Trial Outcomes & Findings for Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis (NCT NCT04602390)
NCT ID: NCT04602390
Last Updated: 2025-05-31
Results Overview
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2025-05-31
Participant Flow
Participant milestones
| Measure |
Part A SAD Cohort 1, 0.3 mg/kg ANK-700
All enrolled patients will receive one dose of 0.3 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part A SAD Cohort 2, 1.0 mg/kg ANK-700
All enrolled patients will receive one dose of 1.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part A SAD Cohort 3, 3.0 mg/kg ANK-700
All enrolled patients will receive one dose of 3.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part B MAD Cohort 4, 0.3 mg/kg ANK-700
All enrolled patients will receive three doses of 0.3 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part B MAD Cohort 5, 1.0 mg/kg ANK-700
All enrolled patients will receive three doses of 1.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part B MAD Cohort Placebo
All enrolled patients will receive three doses of Placebo
Placebo: Intravenous (IV) infusion
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
9
|
8
|
8
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
9
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Part A SAD Cohort 1, 0.3 mg/kg ANK-700
All enrolled patients will receive one dose of 0.3 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part A SAD Cohort 2, 1.0 mg/kg ANK-700
All enrolled patients will receive one dose of 1.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part A SAD Cohort 3, 3.0 mg/kg ANK-700
All enrolled patients will receive one dose of 3.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part B MAD Cohort 4, 0.3 mg/kg ANK-700
All enrolled patients will receive three doses of 0.3 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part B MAD Cohort 5, 1.0 mg/kg ANK-700
All enrolled patients will receive three doses of 1.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part B MAD Cohort Placebo
All enrolled patients will receive three doses of Placebo
Placebo: Intravenous (IV) infusion
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Part A SAD Cohort 2, 1.0 mg/kg ANK-700
n=3 Participants
All enrolled patients will receive one dose of 1.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part A SAD Cohort 1, 0.3 mg/kg ANK-700
n=3 Participants
All enrolled patients will receive one dose of 0.3 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part A SAD Cohort 3, 3.0 mg/kg ANK-700
n=3 Participants
All enrolled patients will receive one dose of 3.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part B MAD Cohort 4, 0.3 mg/kg ANK-700
n=9 Participants
All enrolled patients will receive three doses of 0.3 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part B MAD Cohort 5, 1.0 mg/kg ANK-700
n=8 Participants
All enrolled patients will receive three doses of 1.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part B MAD Cohort Placebo
n=8 Participants
All enrolled patients will receive three doses of Placebo
Placebo: Intravenous (IV) infusion
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
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=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
47.0 years
STANDARD_DEVIATION 7.00 • n=5 Participants
|
50.3 years
STANDARD_DEVIATION 6.43 • n=7 Participants
|
48.7 years
STANDARD_DEVIATION 9.87 • n=5 Participants
|
49.1 years
STANDARD_DEVIATION 8.43 • n=4 Participants
|
50.9 years
STANDARD_DEVIATION 7.49 • n=21 Participants
|
44 years
STANDARD_DEVIATION 9.59 • n=8 Participants
|
48.2 years
STANDARD_DEVIATION 8.18 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
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=8 Participants
|
0 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
8 participants
n=21 Participants
|
8 participants
n=8 Participants
|
34 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: All patients who received any amount of study drug with treatment group based on the dose level received.
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
Outcome measures
| Measure |
Part A SAD Cohort 1, 0.3 mg/kg ANK-700
n=3 Participants
All enrolled patients will receive one dose of 0.3 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part A SAD Cohort 2, 1.0 mg/kg ANK-700
n=3 Participants
All enrolled patients will receive one dose of 1.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part A SAD Cohort 3, 3.0 mg/kg ANK-700
n=3 Participants
All enrolled patients will receive one dose of 3.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part B MAD Cohort 4, 0.3 mg/kg ANK-700
n=9 Participants
All enrolled patients will receive three doses of 0.3 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part B MAD Cohort 5, 1.0 mg/kg ANK-700
n=8 Participants
All enrolled patients will receive three doses of 1.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part B MAD Cohort Placebo
n=8 Participants
All enrolled patients will receive three doses of Placebo
Placebo: Intravenous (IV) infusion
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAE
|
2 Participants
|
1 Participants
|
3 Participants
|
9 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Grade 3 or higher TEAE
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
SAE
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
no TEAE
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Days 1 and 7: One PK sample was taken pre-dose (≥at least 5 min prior to infusion), with all subsequent PK samples taken after end of infusion at the following time points: 0 min, 7min, 15min, 30min, 1h, 2h, 3h, 4h, 6h, 8hPopulation: PK Analysis Set (PKAS) included all enrolled patients who received ≥ 1 complete dose of study drug and had ≥ 1 pre-dose and 1 post-dose measurement.
Geometric mean of maximum plasma concentration (Cmax)
Outcome measures
| Measure |
Part A SAD Cohort 1, 0.3 mg/kg ANK-700
n=2 Participants
All enrolled patients will receive one dose of 0.3 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part A SAD Cohort 2, 1.0 mg/kg ANK-700
n=3 Participants
All enrolled patients will receive one dose of 1.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part A SAD Cohort 3, 3.0 mg/kg ANK-700
n=2 Participants
All enrolled patients will receive one dose of 3.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part B MAD Cohort 4, 0.3 mg/kg ANK-700
n=8 Participants
All enrolled patients will receive three doses of 0.3 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part B MAD Cohort 5, 1.0 mg/kg ANK-700
n=8 Participants
All enrolled patients will receive three doses of 1.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part B MAD Cohort Placebo
All enrolled patients will receive three doses of Placebo
Placebo: Intravenous (IV) infusion
|
|---|---|---|---|---|---|---|
|
CMAX
Day 1
|
NA ng/mL
Interval 1308.0 to 1349.0
not applicable; insufficient number of samples to calculate
|
7120.7 ng/mL
Interval 3380.0 to 12096.0
|
NA ng/mL
Interval 20462.0 to 33374.0
not applicable; insufficient number of samples to calculate
|
800.28 ng/mL
Interval 105.0 to 1448.0
|
3816 ng/mL
Interval 1830.0 to 9760.0
|
—
|
|
CMAX
Day 7
|
—
|
—
|
—
|
540.99 ng/mL
Interval 42.6 to 1650.0
|
1942.2 ng/mL
Interval 197.0 to 9570.0
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7: One PK sample was taken pre-dose (≥at least 5 min prior to infusion), with all subsequent PK samples taken after the end-of-infusion at the following time points: 0 min, 7 min, 15min, 30 min, 1h, 2h, 3h, 4h, 6h, 8hPopulation: PK Analysis Set (PKAS) included all enrolled patients who received ≥ 1 complete dose of study drug and had ≥ 1 pre-dose and 1 post-dose measurement.
Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC last)
Outcome measures
| Measure |
Part A SAD Cohort 1, 0.3 mg/kg ANK-700
n=2 Participants
All enrolled patients will receive one dose of 0.3 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part A SAD Cohort 2, 1.0 mg/kg ANK-700
n=3 Participants
All enrolled patients will receive one dose of 1.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part A SAD Cohort 3, 3.0 mg/kg ANK-700
n=2 Participants
All enrolled patients will receive one dose of 3.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part B MAD Cohort 4, 0.3 mg/kg ANK-700
n=8 Participants
All enrolled patients will receive three doses of 0.3 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part B MAD Cohort 5, 1.0 mg/kg ANK-700
n=8 Participants
All enrolled patients will receive three doses of 1.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
Part B MAD Cohort Placebo
All enrolled patients will receive three doses of Placebo
Placebo: Intravenous (IV) infusion
|
|---|---|---|---|---|---|---|
|
AUC Last
Day 1
|
NA h*ng/mL
Interval 431.0 to 488.0
not applicable; insufficient number of samples to calculate
|
3620 h*ng/mL
Interval 1530.0 to 6270.0
|
NA h*ng/mL
Interval 13600.0 to 19800.0
not applicable; insufficient number of samples to calculate
|
309 h*ng/mL
Interval 45.1 to 551.0
|
1620 h*ng/mL
Interval 529.0 to 4480.0
|
—
|
|
AUC Last
Day 7
|
—
|
—
|
—
|
217 h*ng/mL
Interval 16.2 to 661.0
|
887 h*ng/mL
Interval 149.0 to 4700.0
|
—
|
Adverse Events
ANK-700 SAD Cohort 1, 0.3 mg/kg ANK-700
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
ANK-700 SAD Cohort 2, 1.0 mg/kg ANK-700
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ANK-700 SAD Cohort 3, 3.0 mg/kg ANK-700
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MAD Cohort 4, 0.3 mg/kg ANK-700
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
MAD Cohort 5, 1.0 mg/kg ANK-700
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
MAD Cohort Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ANK-700 SAD Cohort 1, 0.3 mg/kg ANK-700
n=3 participants at risk
All enrolled patients will receive one dose of 0.3 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
ANK-700 SAD Cohort 2, 1.0 mg/kg ANK-700
n=3 participants at risk
All enrolled patients will receive one dose of 1.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
ANK-700 SAD Cohort 3, 3.0 mg/kg ANK-700
n=3 participants at risk
All enrolled patients will receive one dose of 3.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
MAD Cohort 4, 0.3 mg/kg ANK-700
n=9 participants at risk
All enrolled patients will receive three doses of 0.3 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
MAD Cohort 5, 1.0 mg/kg ANK-700
n=8 participants at risk
All enrolled patients will receive three doses of 1.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
MAD Cohort Placebo
n=8 participants at risk
All enrolled patients will receive three doses of Placebo
Placebo: Intravenous (IV) infusion
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Psychiatric disorders
Psychotic disorder
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
Other adverse events
| Measure |
ANK-700 SAD Cohort 1, 0.3 mg/kg ANK-700
n=3 participants at risk
All enrolled patients will receive one dose of 0.3 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
ANK-700 SAD Cohort 2, 1.0 mg/kg ANK-700
n=3 participants at risk
All enrolled patients will receive one dose of 1.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
ANK-700 SAD Cohort 3, 3.0 mg/kg ANK-700
n=3 participants at risk
All enrolled patients will receive one dose of 3.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
MAD Cohort 4, 0.3 mg/kg ANK-700
n=9 participants at risk
All enrolled patients will receive three doses of 0.3 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
MAD Cohort 5, 1.0 mg/kg ANK-700
n=8 participants at risk
All enrolled patients will receive three doses of 1.0 mg/kg ANK-700
ANK-700: Intravenous (IV) infusion
|
MAD Cohort Placebo
n=8 participants at risk
All enrolled patients will receive three doses of Placebo
Placebo: Intravenous (IV) infusion
|
|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
33.3%
3/9 • Number of events 3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
66.7%
2/3 • Number of events 2 • Up to 393 days (1 year + 28 days screening period)
|
44.4%
4/9 • Number of events 7 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 2 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 2 • Up to 393 days (1 year + 28 days screening period)
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 2 • Up to 393 days (1 year + 28 days screening period)
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Nervous system disorders
Amnesia
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Nervous system disorders
Multiple Sclerosis relapse
|
33.3%
1/3 • Number of events 2 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
22.2%
2/9 • Number of events 3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
|
Nervous system disorders
Multiple Sclerosis pseudo relapse
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
22.2%
2/9 • Number of events 2 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Nervous system disorders
Gait spastic
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 2 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 2 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
66.7%
2/3 • Number of events 3 • Up to 393 days (1 year + 28 days screening period)
|
22.2%
2/9 • Number of events 2 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
33.3%
3/9 • Number of events 5 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
|
General disorders
Gait disturbance
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
General disorders
Infusion site discolouration
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
General disorders
Non-cardiac checst pain
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
General disorders
Asthenia
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
22.2%
2/9 • Number of events 2 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 2 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
General disorders
Pain
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
22.2%
2/9 • Number of events 3 • Up to 393 days (1 year + 28 days screening period)
|
50.0%
4/8 • Number of events 4 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
|
Infections and infestations
Localised infection
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 2 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Number of events 2 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • Number of events 2 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Investigations
Blood alkaline phsophatase increased
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
|
Investigations
Lymphocyte percentage decreased
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Eye disorders
Eye pain
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Eye disorders
Eye irritation
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
|
Musculoskeletal and connective tissue disorders
Arthalgia
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
22.2%
2/9 • Number of events 2 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
|
Musculoskeletal and connective tissue disorders
Greater trochanteric pain syndrome
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
33.3%
3/9 • Number of events 3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
22.2%
2/9 • Number of events 2 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Musculoskeletal and connective tissue disorders
Facial myokymia
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Psychiatric disorders
Depersonalisation/derealization disorder
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Psychiatric disorders
Psychotic disorder
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
22.2%
2/9 • Number of events 2 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Renal and urinary disorders
Dysuria
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
11.1%
1/9 • Number of events 3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/3 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/9 • Up to 393 days (1 year + 28 days screening period)
|
0.00%
0/8 • Up to 393 days (1 year + 28 days screening period)
|
12.5%
1/8 • Number of events 1 • Up to 393 days (1 year + 28 days screening period)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place