Trial Outcomes & Findings for A Study of Galcanezumab in Healthy Participants. (NCT NCT02836613)
NCT ID: NCT02836613
Last Updated: 2019-03-13
Results Overview
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
160 participants
Primary outcome timeframe
8, 24, 48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688 and 3360 hours post dose
Results posted on
2019-03-13
Participant Flow
Open label, randomized, parallel group with study drug administration on Day 1 and up to 20 weeks blood sampling.
Participant milestones
| Measure |
Galcanezumab Pre Filled Syringe (PFS)
Single dose of 240 mg galcanezumab administered subcutaneously (SC) by manual prefilled syringe.
|
Galcanezumab Autoinjector
Single dose of 240 mg galcanezumab administered SC by autoinjector.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
80
|
|
Overall Study
COMPLETED
|
79
|
77
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Galcanezumab Pre Filled Syringe (PFS)
Single dose of 240 mg galcanezumab administered subcutaneously (SC) by manual prefilled syringe.
|
Galcanezumab Autoinjector
Single dose of 240 mg galcanezumab administered SC by autoinjector.
|
|---|---|---|
|
Overall Study
Accidental drowning
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
A Study of Galcanezumab in Healthy Participants.
Baseline characteristics by cohort
| Measure |
Galcanezumab Pre Filled Syringe (PFS)
n=80 Participants
Single dose of 240 mg galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe.
|
Galcanezumab Autoinjector
n=80 Participants
Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
38.4 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Weight
|
78.39 kilograms (kg)
STANDARD_DEVIATION 14.34 • n=5 Participants
|
81.61 kilograms (kg)
STANDARD_DEVIATION 13.72 • n=7 Participants
|
80.00 kilograms (kg)
STANDARD_DEVIATION 14.08 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8, 24, 48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688 and 3360 hours post dosePopulation: All participants who received at least 1 dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab
Outcome measures
| Measure |
Galcanezumab Pre Filled Syringe (PFS)
n=74 Participants
Single dose of 240 mg galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe.
|
Galcanezumab Autoinjector
n=75 Participants
Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab
|
31.5 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 40
|
32.3 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 33
|
PRIMARY outcome
Timeframe: 8, 24, 48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688 and 3360 hours post dosePopulation: All participants who received at least 1 dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-inf\] of Galcanezumab
Outcome measures
| Measure |
Galcanezumab Pre Filled Syringe (PFS)
n=74 Participants
Single dose of 240 mg galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe.
|
Galcanezumab Autoinjector
n=75 Participants
Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf] of Galcanezumab
|
1170 day*ug/mL
Geometric Coefficient of Variation 35
|
1110 day*ug/mL
Geometric Coefficient of Variation 35
|
SECONDARY outcome
Timeframe: Pre dose, 24,48,96,120,168,264,336,504,672,1008,1244,1680,2016,2688, and 3360 hours post dosePopulation: All participants who received at least 1 dose of study drug and had evaluable Cmax CGRP PD data.
Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax)
Outcome measures
| Measure |
Galcanezumab Pre Filled Syringe (PFS)
n=74 Participants
Single dose of 240 mg galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe.
|
Galcanezumab Autoinjector
n=75 Participants
Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.
|
|---|---|---|
|
Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax)
|
3.11 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 41
|
3.13 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 48
|
SECONDARY outcome
Timeframe: Pre dose, 24,48,96,120,168,264,336,504,672,1008,1244,1680,2016,2688, and 3360 hours post dosePopulation: All participants who received at least 1 dose of study drug and had evaluable AUC\[0-tlast, CGRP\] PD data.
Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve from Time Zero to Time T, Where T is the Last Time Point with a Measurable Concentration of CGRP (AUC\[0-tlast, CGRP\])
Outcome measures
| Measure |
Galcanezumab Pre Filled Syringe (PFS)
n=66 Participants
Single dose of 240 mg galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe.
|
Galcanezumab Autoinjector
n=63 Participants
Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.
|
|---|---|---|
|
Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration of CGRP (AUC[0-tlast, CGRP])
|
242 day*ng/mL
Geometric Coefficient of Variation 50
|
242 day*ng/mL
Geometric Coefficient of Variation 58
|
Adverse Events
Galcanezumab Pre Filled Syringe (PFS)
Serious events: 1 serious events
Other events: 27 other events
Deaths: 1 deaths
Galcanezumab Autoinjector
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Galcanezumab Pre Filled Syringe (PFS)
n=80 participants at risk
Single dose of 240 mg galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe.
|
Galcanezumab Autoinjector
n=80 participants at risk
Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.
|
|---|---|---|
|
General disorders
Drowning
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Galcanezumab Pre Filled Syringe (PFS)
n=80 participants at risk
Single dose of 240 mg galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe.
|
Galcanezumab Autoinjector
n=80 participants at risk
Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.
|
|---|---|---|
|
Eye disorders
Eye irritation
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
2.5%
2/80 • Number of events 2 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site bruising
|
2.5%
2/80 • Number of events 3 • up to 8 months
All participants who received at least 1 dose of study drug.
|
3.8%
3/80 • Number of events 3 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site erythema
|
2.5%
2/80 • Number of events 2 • up to 8 months
All participants who received at least 1 dose of study drug.
|
5.0%
4/80 • Number of events 6 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site induration
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
2.5%
2/80 • Number of events 3 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site pain
|
2.5%
2/80 • Number of events 2 • up to 8 months
All participants who received at least 1 dose of study drug.
|
12.5%
10/80 • Number of events 14 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site pruritus
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
2.5%
2/80 • Number of events 3 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site swelling
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
2.5%
2/80 • Number of events 2 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tinea pedis
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
4/80 • Number of events 4 • up to 8 months
All participants who received at least 1 dose of study drug.
|
7.5%
6/80 • Number of events 6 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
2.5%
2/80 • Number of events 2 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.5%
2/80 • Number of events 2 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 2 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Investigations
White blood cells urine positive
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 2 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
4/80 • Number of events 5 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
2.5%
2/80 • Number of events 2 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
1/80 • Number of events 2 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
2.5%
2/80 • Number of events 2 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
6.2%
5/80 • Number of events 5 • up to 8 months
All participants who received at least 1 dose of study drug.
|
11.2%
9/80 • Number of events 11 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuritis
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
2.5%
2/80 • Number of events 2 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
1.2%
1/80 • Number of events 1 • up to 8 months
All participants who received at least 1 dose of study drug.
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/80 • up to 8 months
All participants who received at least 1 dose of study drug.
|
1.2%
1/80 • Number of events 1 • up to 8 months
All 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: GT60