Trial Outcomes & Findings for A Study of LY3002813 in Participants With Alzheimer's Disease (NCT NCT01837641)
NCT ID: NCT01837641
Last Updated: 2024-10-04
Results Overview
Data presented are the number of participants who experienced SAEs which were considered to be related to study treatment by the investigator while on treatment and during the follow-up. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
63 participants
Primary outcome timeframe
Day 1 up to Day 253
Results posted on
2024-10-04
Participant Flow
Dose-escalation study in participants(pts) with mild cognitive impairment (MCI) due to Alzheimer's disease (AD).Under an amendment,Pharmacokinetics of unblinded single IV dose of 1 milligram per kilogram (mg/kg) LY3002813 in young,healthy male pts was assessed if absence of amyloid target affected the PK as compared to amyloid-positive pts with AD.
Participant milestones
| Measure |
Placebo IV
Single dose of placebo matching LY3002813 given once, then every 4 weeks for up to 16 weeks by intravenous (IV) infusion.
|
0.1 mg/kg / 0.3 mg/kg LY3002813 IV
Single dose of 0.1 milligram per kilogram (mg/kg) LY3002813 given once, then 0.3 mg/kg LY3002813 every 4 weeks for up to 16 weeks by IV infusion.
|
0.3 mg/kg LY3002813 IV
Single dose of 0.3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
1 mg/kg LY3002813 IV: Healthy Participants
Single dose of 1 mg/kg LY3002813 given once by IV infusion.
|
1 mg/kg LY3002813 IV
Single dose of 1 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
3 mg/kg LY3002813 IV
Single dose of 3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
10 mg/kg LY3002813 IV
Single dose of 10 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
3 mg/kg LY3002813 SC
Single dose of 3 mg/kg LY3002813 given once subcutaneously (SC).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
4
|
7
|
6
|
9
|
11
|
6
|
8
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
12
|
4
|
7
|
6
|
9
|
11
|
6
|
8
|
|
Overall Study
COMPLETED
|
11
|
4
|
7
|
6
|
8
|
9
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
1
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo IV
Single dose of placebo matching LY3002813 given once, then every 4 weeks for up to 16 weeks by intravenous (IV) infusion.
|
0.1 mg/kg / 0.3 mg/kg LY3002813 IV
Single dose of 0.1 milligram per kilogram (mg/kg) LY3002813 given once, then 0.3 mg/kg LY3002813 every 4 weeks for up to 16 weeks by IV infusion.
|
0.3 mg/kg LY3002813 IV
Single dose of 0.3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
1 mg/kg LY3002813 IV: Healthy Participants
Single dose of 1 mg/kg LY3002813 given once by IV infusion.
|
1 mg/kg LY3002813 IV
Single dose of 1 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
3 mg/kg LY3002813 IV
Single dose of 3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
10 mg/kg LY3002813 IV
Single dose of 10 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
3 mg/kg LY3002813 SC
Single dose of 3 mg/kg LY3002813 given once subcutaneously (SC).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Sponsor decision
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Study of LY3002813 in Participants With Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Placebo IV
n=12 Participants
Single dose of placebo matching LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
0.1 mg/kg / 0.3 mg/kg LY3002813 IV
n=4 Participants
Single dose of 0.1 mg/kg LY3002813 given once, then 0.3 mg/kg LY3002813 every 4 weeks for up to 16 weeks by IV infusion.
|
0.3 mg/kg LY3002813 IV
n=7 Participants
Single dose of 0.3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
1 mg/kg LY3002813 IV: Healthy Participants
n=6 Participants
Single dose of 1 mg/kg LY3002813 given once by IV infusion.
|
1 mg/kg LY3002813 IV
n=9 Participants
Single dose of 1 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
3 mg/kg LY3002813 IV
n=11 Participants
Single dose of 3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
10 mg/kg LY3002813 IV
n=6 Participants
Single dose of 10 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
3 mg/kg LY3002813 SC
n=8 Participants
Single dose of 3 mg/kg LY3002813 given once SC.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
76.8 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
71.3 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
75.0 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
25.8 years
STANDARD_DEVIATION 3.3 • n=4 Participants
|
74.7 years
STANDARD_DEVIATION 9.3 • n=21 Participants
|
73.0 years
STANDARD_DEVIATION 8.8 • n=8 Participants
|
72.3 years
STANDARD_DEVIATION 10.7 • n=8 Participants
|
74.5 years
STANDARD_DEVIATION 9.5 • n=24 Participants
|
69.7 years
STANDARD_DEVIATION 16.4 • n=42 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
33 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
30 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
59 Participants
n=42 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
21 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 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
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
38 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
43 Participants
n=42 Participants
|
|
Region of Enrollment
Japan
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
20 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 253Population: All enrolled participants who received at least 1 dose of study drug.
Data presented are the number of participants who experienced SAEs which were considered to be related to study treatment by the investigator while on treatment and during the follow-up. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.
Outcome measures
| Measure |
Placebo IV
n=12 Participants
Single dose of placebo matching LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
0.1 mg/kg / 0.3 mg/kg LY3002813 IV
n=4 Participants
Single dose of 0.1 mg/kg LY3002813 given once, then 0.3 mg/kg LY3002813 every 4 weeks for up to 16 weeks by IV infusion.
|
0.3 mg/kg LY3002813 IV
n=7 Participants
Single dose of 0.3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
1 mg/kg LY3002813 IV: Healthy Participants
n=6 Participants
Single dose of 1 mg/kg LY3002813 given once by IV infusion.
|
1 mg/kg LY3002813 IV
n=9 Participants
Single dose of 1 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
3 mg/kg LY3002813 IV
n=11 Participants
Single dose of 3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
10 mg/kg LY3002813 IV
n=6 Participants
Single dose of 10 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
3 mg/kg LY3002813 SC
n=8 Participants
Single dose of 3 mg/kg LY3002813 given once SC.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, end of infusion for IV or 1h post injection for SC, 3, 24, 72, 96(SC), 120(SC), 144(SC), 168, 336, 504, 672, 1008, 1344, 1680 and 2016 hours (h) post-dosePopulation: All enrolled participants who received at least 1 dose of study drug and have evaluable pharmacokinetic data.
Maximum Concentration (Cmax) of LY3002813 after the first dose was evaluated.
Outcome measures
| Measure |
Placebo IV
n=4 Participants
Single dose of placebo matching LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
0.1 mg/kg / 0.3 mg/kg LY3002813 IV
n=7 Participants
Single dose of 0.1 mg/kg LY3002813 given once, then 0.3 mg/kg LY3002813 every 4 weeks for up to 16 weeks by IV infusion.
|
0.3 mg/kg LY3002813 IV
n=6 Participants
Single dose of 0.3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
1 mg/kg LY3002813 IV: Healthy Participants
n=9 Participants
Single dose of 1 mg/kg LY3002813 given once by IV infusion.
|
1 mg/kg LY3002813 IV
n=11 Participants
Single dose of 1 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
3 mg/kg LY3002813 IV
n=6 Participants
Single dose of 3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
10 mg/kg LY3002813 IV
n=8 Participants
Single dose of 10 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
3 mg/kg LY3002813 SC
Single dose of 3 mg/kg LY3002813 given once SC.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY3002813
|
2.90 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 35
|
5.99 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 77
|
31.5 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 29
|
21.7 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 21
|
71.6 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 24
|
218 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 16
|
12.0 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 34
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, end of infusion for IV or 1h post injection for SC, 3, 24, 72, 96(SC), 120(SC), 144(SC), 168, 336, 504, 672, 1008, 1344, 1680 and 2016h post-dosePopulation: All enrolled participants who received at least 1 dose of study drug and have evaluable pharmacokinetic data.
Area Under the Concentration Versus Time Curve From Time Zero to Infinity \[AUC(0-∞)\] of LY3002813 after the first dose was evaluated.
Outcome measures
| Measure |
Placebo IV
n=4 Participants
Single dose of placebo matching LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
0.1 mg/kg / 0.3 mg/kg LY3002813 IV
n=7 Participants
Single dose of 0.1 mg/kg LY3002813 given once, then 0.3 mg/kg LY3002813 every 4 weeks for up to 16 weeks by IV infusion.
|
0.3 mg/kg LY3002813 IV
n=6 Participants
Single dose of 0.3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
1 mg/kg LY3002813 IV: Healthy Participants
n=9 Participants
Single dose of 1 mg/kg LY3002813 given once by IV infusion.
|
1 mg/kg LY3002813 IV
n=11 Participants
Single dose of 1 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
3 mg/kg LY3002813 IV
n=6 Participants
Single dose of 3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
10 mg/kg LY3002813 IV
n=8 Participants
Single dose of 10 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
3 mg/kg LY3002813 SC
Single dose of 3 mg/kg LY3002813 given once SC.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3002813
|
7.94 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 32
|
26.3 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 33
|
91.6 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 17
|
79.9 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 26
|
263 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 19
|
1140 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 39
|
157 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 41
|
—
|
Adverse Events
Placebo IV
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
0.1 mg/kg / 0.3 mg/kg LY3002813 IV
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
0.3 mg/kg LY3002813 IV
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
1 mg/kg LY3002813 IV: Healthy Participants
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
1 mg/kg LY3002813 IV
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
3 mg/kg LY3002813 IV
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
10 mg/kg LY3002813 IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
3 mg/kg LY3002813 SC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo IV
n=12 participants at risk
Single dose of placebo matching LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
0.1 mg/kg / 0.3 mg/kg LY3002813 IV
n=4 participants at risk
Single dose of 0.1 mg/kg LY3002813 given once, then 0.3 mg/kg LY3002813 every 4 weeks for up to 16 weeks by IV infusion.
|
0.3 mg/kg LY3002813 IV
n=7 participants at risk
Single dose of 0.3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
1 mg/kg LY3002813 IV: Healthy Participants
n=6 participants at risk
Single dose of 1 mg/kg LY3002813 given once by IV infusion.
|
1 mg/kg LY3002813 IV
n=9 participants at risk
Single dose of 1 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
3 mg/kg LY3002813 IV
n=11 participants at risk
Single dose of 3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
10 mg/kg LY3002813 IV
n=6 participants at risk
Single dose of 10 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
3 mg/kg LY3002813 SC
n=8 participants at risk
Single dose of 3 mg/kg LY3002813 given once SC.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Placebo IV
n=12 participants at risk
Single dose of placebo matching LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
0.1 mg/kg / 0.3 mg/kg LY3002813 IV
n=4 participants at risk
Single dose of 0.1 mg/kg LY3002813 given once, then 0.3 mg/kg LY3002813 every 4 weeks for up to 16 weeks by IV infusion.
|
0.3 mg/kg LY3002813 IV
n=7 participants at risk
Single dose of 0.3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
1 mg/kg LY3002813 IV: Healthy Participants
n=6 participants at risk
Single dose of 1 mg/kg LY3002813 given once by IV infusion.
|
1 mg/kg LY3002813 IV
n=9 participants at risk
Single dose of 1 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
3 mg/kg LY3002813 IV
n=11 participants at risk
Single dose of 3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
10 mg/kg LY3002813 IV
n=6 participants at risk
Single dose of 10 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion.
|
3 mg/kg LY3002813 SC
n=8 participants at risk
Single dose of 3 mg/kg LY3002813 given once SC.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oral lichen planus
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 2 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
18.2%
2/11 • Number of events 3 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 3 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • Number of events 5 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
27.3%
3/11 • Number of events 8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram abnormal
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral microhaemorrhage
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Apathy
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Delirium
|
8.3%
1/12 • Number of events 2 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Persecutory delusion
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Restlessness
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
16.7%
2/12 • Number of events 4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Micrographic skin surgery
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Ischaemia
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/12 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60