Trial Outcomes & Findings for A Study of LY3451838 in Participants With Migraine (NCT NCT04498910)
NCT ID: NCT04498910
Last Updated: 2023-11-28
Results Overview
Migraine Headache Day is a calendar day on which a migraine or probable migraine headache occurs. Per International Headache Society \[IHS\] International Classification of Headache Disorders version 3 \[ICHD-3\], migraine is defined as a headache, with or without aura, of \>=30 minutes duration with both of the following required features (A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity (B) During headache at least 1 of the following: Nausea and/or vomiting; Photophobia and phonophobia. Least square mean was assessed using Bayesian Mixed Model Analysis with baseline number of monthly migraine headache days as a covariate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Baseline, Month 1
Results posted on
2023-11-28
Participant Flow
Participant milestones
| Measure |
1500 Milligram (mg) LY3451838
Participants received a single intravenous (IV) dose of 1500 mg LY3451838.
|
Placebo
Participants received a single IV dose of placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
Received at Least One Dose of Study Drug
|
19
|
19
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
1500 Milligram (mg) LY3451838
Participants received a single intravenous (IV) dose of 1500 mg LY3451838.
|
Placebo
Participants received a single IV dose of placebo.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Study of LY3451838 in Participants With Migraine
Baseline characteristics by cohort
| Measure |
1500 mg LY3451838
n=19 Participants
Participants received a single IV dose of 1500 mg LY3451838.
|
Placebo
n=19 Participants
Participants received a single IV dose of placebo.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 10.84 • n=93 Participants
|
48.0 years
STANDARD_DEVIATION 12.59 • n=4 Participants
|
48.3 years
STANDARD_DEVIATION 11.59 • n=27 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Monthly Number of Migraine Headache Days
|
14.0 migraine days per month
STANDARD_DEVIATION 6.21 • n=93 Participants
|
13.0 migraine days per month
STANDARD_DEVIATION 7.71 • n=4 Participants
|
13.5 migraine days per month
STANDARD_DEVIATION 6.92 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 1Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
Migraine Headache Day is a calendar day on which a migraine or probable migraine headache occurs. Per International Headache Society \[IHS\] International Classification of Headache Disorders version 3 \[ICHD-3\], migraine is defined as a headache, with or without aura, of \>=30 minutes duration with both of the following required features (A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity (B) During headache at least 1 of the following: Nausea and/or vomiting; Photophobia and phonophobia. Least square mean was assessed using Bayesian Mixed Model Analysis with baseline number of monthly migraine headache days as a covariate.
Outcome measures
| Measure |
1500 mg LY3451838
n=19 Participants
Participants received a single IV dose of 1500 mg LY3451838.
|
Placebo
n=19 Participants
Participants received a single IV dose of Placebo.
|
|---|---|---|
|
Change From Baseline in the Number of Monthly Migraine Headache Days During 1-Month
|
-3.8 migraine days per month
Interval -5.8 to -1.7
|
-2.7 migraine days per month
Interval -5.0 to -0.3
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
Migraine Headache Day is a calendar day on which a migraine or probable migraine headache occurs. Per International Headache Society \[IHS\] International Classification of Headache Disorders version 3 \[ICHD-3\], migraine is defined as a headache, with or without aura, of \>=30 minutes duration with both of the following required features (A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity (B) During headache at least 1 of the following: Nausea and/or vomiting; Photophobia and phonophobia. Least square mean was assessed using Bayesian Mixed Model Analysis with baseline number of monthly migraine headache days as a covariate.
Outcome measures
| Measure |
1500 mg LY3451838
n=19 Participants
Participants received a single IV dose of 1500 mg LY3451838.
|
Placebo
n=19 Participants
Participants received a single IV dose of Placebo.
|
|---|---|---|
|
Change From Baseline in the Number of Monthly Headache Days During 3-Month
|
-3.6 migraine days per month
Interval -5.9 to -1.4
|
-2.2 migraine days per month
Interval -4.7 to 0.4
|
SECONDARY outcome
Timeframe: Month 1Population: All randomized participants who received at least one dose of study drug.
Percentage of Participants with ≥50% Reduction from Baseline in Monthly Migraine Headache Days are reported.
Outcome measures
| Measure |
1500 mg LY3451838
n=19 Participants
Participants received a single IV dose of 1500 mg LY3451838.
|
Placebo
n=19 Participants
Participants received a single IV dose of Placebo.
|
|---|---|---|
|
Percentage of Participants With ≥50% Reduction From Baseline in Monthly Migraine Headache Days
|
21.1 Percentage of participants
|
26.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to 5 MonthsPopulation: All randomized participants who received at least one dose of study drug.
Number of Participants with at least one TEAEs are reported. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
1500 mg LY3451838
n=19 Participants
Participants received a single IV dose of 1500 mg LY3451838.
|
Placebo
n=19 Participants
Participants received a single IV dose of Placebo.
|
|---|---|---|
|
Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
|
11 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 5 MonthsPopulation: All randomized participants who received at least one dose of study drug.
Number of Participants with at least one SAEs are reported. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
1500 mg LY3451838
n=19 Participants
Participants received a single IV dose of 1500 mg LY3451838.
|
Placebo
n=19 Participants
Participants received a single IV dose of Placebo.
|
|---|---|---|
|
Number of Participants With at Least One Serious Adverse Events (SAEs)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-infusion, end of infusion, 3hours(h), 365h, 730h, 1095h, 1460h, 1825h, 2190h, 2920h, 3650h post-infusionPopulation: All randomized participants who received at least one dose of LY3451838 and had evaluable serum concentrations.
PK: AUC(0-t) of LY3451838
Outcome measures
| Measure |
1500 mg LY3451838
n=19 Participants
Participants received a single IV dose of 1500 mg LY3451838.
|
Placebo
Participants received a single IV dose of Placebo.
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Serum Concentration (AUC 0-t) of LY3451838
|
176000 microgram*hour per milliliter (μg*h/mL)
Geometric Coefficient of Variation 26.5
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion, end of infusion, 3hours(h), 365h, 730h, 1095h, 1460h, 1825h, 2190h, 2920h, 3650h post-infusionPopulation: All randomized participants who received at least one dose of LY3451838 and had evaluable serum concentrations.
PK: Cmax of LY3451838
Outcome measures
| Measure |
1500 mg LY3451838
n=19 Participants
Participants received a single IV dose of 1500 mg LY3451838.
|
Placebo
Participants received a single IV dose of Placebo.
|
|---|---|---|
|
PK: Maximum Observed Serum Concentration (Cmax) of LY3451838
|
613 microgram per milliliter (µg/ml)
Geometric Coefficient of Variation 32.6
|
—
|
Adverse Events
1500 mg LY3451838
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1500 mg LY3451838
n=19 participants at risk
Participants received a single IV dose of 1500 mg LY3451838.
|
Placebo
n=19 participants at risk
Participants received a single IV dose of placebo.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
1500 mg LY3451838
n=19 participants at risk
Participants received a single IV dose of 1500 mg LY3451838.
|
Placebo
n=19 participants at risk
Participants received a single IV dose of placebo.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
1/19 • Number of events 2 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.8%
3/19 • Number of events 3 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
21.1%
4/19 • Number of events 5 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.5%
2/19 • Number of events 2 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Viral infection
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 2 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase abnormal
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Biopsy breast normal
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Heart rate increased
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Lumbar puncture
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Sars-cov-2 test positive
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Cataract
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 2 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chest pain
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chills
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Malaise
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Acute sinusitis
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
21.1%
4/19 • Number of events 5 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.5%
2/19 • Number of events 2 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.5%
2/19 • Number of events 2 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.5%
2/19 • Number of events 2 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.5%
2/19 • Number of events 2 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Aphasia
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Aura
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Migraine
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Confusional state
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Major depression
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Dysuria
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.5%
2/19 • Number of events 2 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Pollakiuria
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/18 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/19 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline up to 5 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60