Trial Outcomes & Findings for Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE) (NCT NCT03679676)

Last Updated: 2026-05-29

Results Overview

Success is defined as passing a cumulative dose of \>=1,043 mg at the Week 44 DBPCFC if the subject has no or mild objective reactions. The primary endpoints would be compared between cohort A and cohort B. Outcome measures (rates) are presented as the percent of participants who passed, with the additional detail of the counts of participants who pass, and the participants who were analyzed.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

130 participants

Primary outcome timeframe

44 weeks

Results posted on

2026-05-29

Participant Flow

130 participants were consented and screened for eligibility; 108 participants were randomized to receive biologics treatment/placebo, Oral Immunotherapy (OIT) and Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)

Participant milestones

Participant milestones
Measure	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy Participants receive omalizumab for 8 weeks, followed by 24 weeks of placebo for dupilumab and multi oral immunotherapy.	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy Participants receive omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy Participants receive placebo for omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.
Overall Study STARTED	49	49	10
Overall Study Completed at Least One DBPCFC at Week 44	34	45	8
Overall Study COMPLETED	34	45	8
Overall Study NOT COMPLETED	15	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy Participants receive omalizumab for 8 weeks, followed by 24 weeks of placebo for dupilumab and multi oral immunotherapy.	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy Participants receive omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy Participants receive placebo for omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.
Overall Study Adverse Event	8	0	0
Overall Study Non-compliance	3	0	0
Overall Study Study Burden	4	3	1
Overall Study Individual safety stopping rules	0	1	1

Baseline Characteristics

Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy n=49 Participants Participants receive omalizumab for 8 weeks, followed by 24 weeks of placebo for dupilumab and multi oral immunotherapy.	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=49 Participants Participants receive omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=10 Participants Participants receive placebo for omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.	Total n=108 Participants Total of all reporting groups
Age, Continuous	12.14 Years STANDARD_DEVIATION 6.66 • n=51 Participants	13.08 Years STANDARD_DEVIATION 7.22 • n=14 Participants	10.15 Years STANDARD_DEVIATION 3.42 • n=65 Participants	12.38 Years STANDARD_DEVIATION 6.71 • n=57 Participants
Sex: Female, Male Female	16 Participants n=51 Participants	15 Participants n=14 Participants	4 Participants n=65 Participants	35 Participants n=57 Participants
Sex: Female, Male Male	33 Participants n=51 Participants	34 Participants n=14 Participants	6 Participants n=65 Participants	73 Participants n=57 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=51 Participants	4 Participants n=14 Participants	1 Participants n=65 Participants	7 Participants n=57 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=51 Participants	43 Participants n=14 Participants	9 Participants n=65 Participants	98 Participants n=57 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=51 Participants	2 Participants n=14 Participants	0 Participants n=65 Participants	3 Participants n=57 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants	0 Participants n=57 Participants
Race (NIH/OMB) Asian	15 Participants n=51 Participants	19 Participants n=14 Participants	3 Participants n=65 Participants	37 Participants n=57 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=51 Participants	2 Participants n=14 Participants	0 Participants n=65 Participants	2 Participants n=57 Participants
Race (NIH/OMB) Black or African American	2 Participants n=51 Participants	1 Participants n=14 Participants	0 Participants n=65 Participants	3 Participants n=57 Participants
Race (NIH/OMB) White	18 Participants n=51 Participants	15 Participants n=14 Participants	1 Participants n=65 Participants	34 Participants n=57 Participants
Race (NIH/OMB) More than one race	13 Participants n=51 Participants	11 Participants n=14 Participants	4 Participants n=65 Participants	28 Participants n=57 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=51 Participants	1 Participants n=14 Participants	2 Participants n=65 Participants	4 Participants n=57 Participants
Region of Enrollment United States	49 Participants n=51 Participants	49 Participants n=14 Participants	10 Participants n=65 Participants	108 Participants n=57 Participants
Atopic Disorder Asthma	31 Participants n=51 Participants	30 Participants n=14 Participants	3 Participants n=65 Participants	64 Participants n=57 Participants
Atopic Disorder Atopic Dermatitis	43 Participants n=51 Participants	41 Participants n=14 Participants	9 Participants n=65 Participants	93 Participants n=57 Participants
Atopic Disorder Allergic Rhinitis	32 Participants n=51 Participants	25 Participants n=14 Participants	6 Participants n=65 Participants	63 Participants n=57 Participants
Number of Allergens 3 food allergens	31 Participants n=51 Participants	30 Participants n=14 Participants	6 Participants n=65 Participants	67 Participants n=57 Participants
Number of Allergens 2 food allergens	18 Participants n=51 Participants	19 Participants n=14 Participants	4 Participants n=65 Participants	41 Participants n=57 Participants

PRIMARY outcome

Timeframe: 44 weeks

Outcome measures

Outcome measures
Measure	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=10 Participants Participants receive placebo for omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy n=49 Participants Participants receive omalizumab for 8 weeks, followed by 24 weeks of placebo for dupilumab and multi oral immunotherapy.	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=49 Participants Participants receive omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.
The Success Rates of Passing a Peanut Double-Blind Placebo Controlled Food Challenge (DBPCFC)	3 Participants	19 Participants	27 Participants

PRIMARY outcome

Timeframe: 44 weeks

Outcome measures

Outcome measures
Measure	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=10 Participants Participants receive placebo for omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy n=49 Participants Participants receive omalizumab for 8 weeks, followed by 24 weeks of placebo for dupilumab and multi oral immunotherapy.	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=49 Participants Participants receive omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.
The Success Rates of Passing a DBPCFC to Peanut and at Least One Other FA	3 Participants	17 Participants	24 Participants

PRIMARY outcome

Timeframe: 44 weeks

Population: Participants who had 3 allergens as part of their OIT.

Outcome measures

Outcome measures
Measure	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=6 Participants Participants receive placebo for omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy n=31 Participants Participants receive omalizumab for 8 weeks, followed by 24 weeks of placebo for dupilumab and multi oral immunotherapy.	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=30 Participants Participants receive omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.
The Success Rates of Passing a DBPCFC to Peanut and Two Other FAs	2 Participants	6 Participants	9 Participants

SECONDARY outcome

Timeframe: 44 weeks

Outcome measures (rates) are presented as the percent of participants who passed, with the additional detail of the counts of participants who pass, and the participants who were analyzed.

Outcome measures

Outcome measures
Measure	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=10 Participants Participants receive placebo for omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy n=49 Participants Participants receive omalizumab for 8 weeks, followed by 24 weeks of placebo for dupilumab and multi oral immunotherapy.	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=49 Participants Participants receive omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.
Proportion of Participants Who Successfully Pass DBPCFCs to a Cumulative Dose of >=1,043 mg Protein to 1, 2, or 3 FAs When Applicable at Week 44 Any one allergen	7 Participants	25 Participants	38 Participants
Proportion of Participants Who Successfully Pass DBPCFCs to a Cumulative Dose of >=1,043 mg Protein to 1, 2, or 3 FAs When Applicable at Week 44 Any two allergens	3 Participants	20 Participants	25 Participants

SECONDARY outcome

Timeframe: 32 weeks

Population: 67 of 108 participants were undergoing OIT for 3 allergens; 41 of 108 participants were undergoing OIT for 2 allergens

Outcome measures (rates) are presented as the percent of participants who passed, with the additional detail of the counts of participants who pass, and the participants who were analyzed.

Outcome measures

Outcome measures
Measure	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=10 Participants Participants receive placebo for omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy n=49 Participants Participants receive omalizumab for 8 weeks, followed by 24 weeks of placebo for dupilumab and multi oral immunotherapy.	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=49 Participants Participants receive omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.
Proportion of Participants Who Successfully Pass DBPCFCs to a Cumulative Dose of ≥2,043 mg to 1, 2, or 3 FAs When Applicable at Week 32 Any one allergen	8 Participants	32 Participants	46 Participants
Proportion of Participants Who Successfully Pass DBPCFCs to a Cumulative Dose of ≥2,043 mg to 1, 2, or 3 FAs When Applicable at Week 32 Any two allergens	8 Participants	30 Participants	43 Participants
Proportion of Participants Who Successfully Pass DBPCFCs to a Cumulative Dose of ≥2,043 mg to 1, 2, or 3 FAs When Applicable at Week 32 Three Allergens	2 Participants	17 Participants	22 Participants

SECONDARY outcome

Timeframe: week 32 and/or 44

Population: Number of participants who underwent DBPCFCs for respective FAs

Outcome measures (rates) are presented as the percent of participants who passed, with the additional detail of the counts of participants who pass, and the participants who were analyzed.

Outcome measures

Outcome measures
Measure	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=10 Participants Participants receive placebo for omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy n=49 Participants Participants receive omalizumab for 8 weeks, followed by 24 weeks of placebo for dupilumab and multi oral immunotherapy.	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=49 Participants Participants receive omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.
Proportion of Participants Who Pass DBPCFCs for Each FA at a Cumulative Dose of ≥1,043 mg, ≥2,043 mg, or ≥4,043 mg at Week 32 and/or Week 44. Peanut	8 Participants	31 Participants	45 Participants
Proportion of Participants Who Pass DBPCFCs for Each FA at a Cumulative Dose of ≥1,043 mg, ≥2,043 mg, or ≥4,043 mg at Week 32 and/or Week 44. Cashew	5 Participants	15 Participants	24 Participants
Proportion of Participants Who Pass DBPCFCs for Each FA at a Cumulative Dose of ≥1,043 mg, ≥2,043 mg, or ≥4,043 mg at Week 32 and/or Week 44. Walnut	6 Participants	17 Participants	12 Participants
Proportion of Participants Who Pass DBPCFCs for Each FA at a Cumulative Dose of ≥1,043 mg, ≥2,043 mg, or ≥4,043 mg at Week 32 and/or Week 44. Hazelnut	1 Participants	6 Participants	10 Participants
Proportion of Participants Who Pass DBPCFCs for Each FA at a Cumulative Dose of ≥1,043 mg, ≥2,043 mg, or ≥4,043 mg at Week 32 and/or Week 44. Egg	0 Participants	4 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline and week 32 and/or 44

Population: 67 of 108 participants were undergoing OIT for 3 allergens; 41 of 108 participants were undergoing OIT for 2 allergens

Outcome measures (rates) are presented as the percent of participants who had a 10-fold change, with the additional detail of the counts of participants who had that change, and the participants who were analyzed.

Outcome measures

Outcome measures
Measure	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=10 Participants Participants receive placebo for omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy n=49 Participants Participants receive omalizumab for 8 weeks, followed by 24 weeks of placebo for dupilumab and multi oral immunotherapy.	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=49 Participants Participants receive omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.
Proportion of Participants Who Have a 10-fold Change in the Cumulative Tolerance Dose for Each FA at Weeks 32 and/or Week 44, Compared to Baseline Peanut	8 Participants	32 Participants	46 Participants
Proportion of Participants Who Have a 10-fold Change in the Cumulative Tolerance Dose for Each FA at Weeks 32 and/or Week 44, Compared to Baseline Cashew	5 Participants	15 Participants	25 Participants
Proportion of Participants Who Have a 10-fold Change in the Cumulative Tolerance Dose for Each FA at Weeks 32 and/or Week 44, Compared to Baseline Walnut	6 Participants	17 Participants	12 Participants
Proportion of Participants Who Have a 10-fold Change in the Cumulative Tolerance Dose for Each FA at Weeks 32 and/or Week 44, Compared to Baseline Hazelnut	1 Participants	6 Participants	9 Participants
Proportion of Participants Who Have a 10-fold Change in the Cumulative Tolerance Dose for Each FA at Weeks 32 and/or Week 44, Compared to Baseline Egg	0 Participants	4 Participants	8 Participants

Adverse Events

Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy n=49 participants at risk Participants receive omalizumab for 8 weeks, followed by 24 weeks of placebo for dupilumab and multi oral immunotherapy.	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=49 participants at risk Participants receive omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=10 participants at risk Participants receive placebo for omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.
Gastrointestinal disorders Stomach pain	0.00% 0/49 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	0.00% 0/49 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Nervous system disorders Dizziness	0.00% 0/49 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	0.00% 0/49 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Gastrointestinal disorders Abdominal pain	0.00% 0/49 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	2.0% 1/49 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	0.00% 0/10 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Gastrointestinal disorders Nausea	0.00% 0/49 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	2.0% 1/49 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	0.00% 0/10 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Gastrointestinal disorders Vomiting	0.00% 0/49 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	2.0% 1/49 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	0.00% 0/10 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Gastrointestinal disorders Itchy mouth/throat/lips/tongue	0.00% 0/49 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	0.00% 0/49 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	10.0% 1/10 • Number of events 2 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/49 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	2.0% 1/49 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	0.00% 0/10 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/49 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	2.0% 1/49 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	0.00% 0/10 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Vascular disorders Flushing	0.00% 0/49 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	2.0% 1/49 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	0.00% 0/10 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Vascular disorders Hypotension	0.00% 0/49 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	2.0% 1/49 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.

Other adverse events

Additional Information

Sharon Chinthrajah

Sean N Parker Center for Allergy & Asthma Research at Stanford University

Phone: 650-521-7237

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy n=49 participants at risk Participants receive omalizumab for 8 weeks, followed by 24 weeks of placebo for dupilumab and multi oral immunotherapy.	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=49 participants at risk Participants receive omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n=10 participants at risk Participants receive placebo for omalizumab for 8 weeks, followed by 24 weeks of dupilumab and multi-food oral immunotherapy.
General disorders Edema face	2.0% 1/49 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	4.1% 2/49 • Number of events 2 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	20.0% 2/10 • Number of events 2 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
General disorders Facial pain	0.00% 0/49 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	0.00% 0/49 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Immune system disorders Allergic reaction	10.2% 5/49 • Number of events 5 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	10.2% 5/49 • Number of events 8 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Respiratory, thoracic and mediastinal disorders Cough	10.2% 5/49 • Number of events 6 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	18.4% 9/49 • Number of events 10 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	20.0% 2/10 • Number of events 2 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Respiratory, thoracic and mediastinal disorders Nasal congestion	12.2% 6/49 • Number of events 6 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	14.3% 7/49 • Number of events 10 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Respiratory, thoracic and mediastinal disorders Wheezing	6.1% 3/49 • Number of events 4 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	12.2% 6/49 • Number of events 8 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	20.0% 2/10 • Number of events 2 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/49 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	14.3% 7/49 • Number of events 10 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	20.0% 2/10 • Number of events 2 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Respiratory, thoracic and mediastinal disorders Chest tightness	4.1% 2/49 • Number of events 2 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	8.2% 4/49 • Number of events 5 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	0.00% 0/10 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Respiratory, thoracic and mediastinal disorders Throat tightness	4.1% 2/49 • Number of events 3 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	6.1% 3/49 • Number of events 4 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	0.00% 0/10 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Respiratory, thoracic and mediastinal disorders Rhinorrhea (Runny nose)	4.1% 2/49 • Number of events 2 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	6.1% 3/49 • Number of events 3 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Respiratory, thoracic and mediastinal disorders Throat Sensation	4.1% 2/49 • Number of events 2 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	6.1% 3/49 • Number of events 3 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	0.00% 0/10 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Eye disorders Conjunctivitis	6.1% 3/49 • Number of events 3 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	12.2% 6/49 • Number of events 8 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Gastrointestinal disorders Abdominal pain	20.4% 10/49 • Number of events 19 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	24.5% 12/49 • Number of events 17 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	30.0% 3/10 • Number of events 3 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Gastrointestinal disorders Vomiting	28.6% 14/49 • Number of events 39 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	6.1% 3/49 • Number of events 16 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Gastrointestinal disorders Nausea	22.4% 11/49 • Number of events 19 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	8.2% 4/49 • Number of events 5 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	20.0% 2/10 • Number of events 3 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Gastrointestinal disorders Itchy mouth/throat/lips/tongue	10.2% 5/49 • Number of events 6 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	16.3% 8/49 • Number of events 11 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	30.0% 3/10 • Number of events 4 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Gastrointestinal disorders Diarrhea	2.0% 1/49 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	6.1% 3/49 • Number of events 3 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	20.0% 2/10 • Number of events 2 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Gastrointestinal disorders Stomach pain	4.1% 2/49 • Number of events 2 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	0.00% 0/49 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
General disorders Injection site reaction	18.4% 9/49 • Number of events 20 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	24.5% 12/49 • Number of events 26 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	0.00% 0/10 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
General disorders Pain	6.1% 3/49 • Number of events 5 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	8.2% 4/49 • Number of events 5 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
General disorders Localized edema	4.1% 2/49 • Number of events 2 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	2.0% 1/49 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Respiratory, thoracic and mediastinal disorders Sneezing	2.0% 1/49 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	6.1% 3/49 • Number of events 4 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Skin and subcutaneous tissue disorders Urticaria	10.2% 5/49 • Number of events 6 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	22.4% 11/49 • Number of events 17 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	40.0% 4/10 • Number of events 4 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Skin and subcutaneous tissue disorders Pruritus	8.2% 4/49 • Number of events 4 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	16.3% 8/49 • Number of events 12 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	20.0% 2/10 • Number of events 2 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Skin and subcutaneous tissue disorders Rash	2.0% 1/49 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	14.3% 7/49 • Number of events 12 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	0.00% 0/10 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Skin and subcutaneous tissue disorders Erythema (flushing)	2.0% 1/49 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	8.2% 4/49 • Number of events 5 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.
Vascular disorders Flushing	2.0% 1/49 • Number of events 1 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	6.1% 3/49 • Number of events 4 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.	0.00% 0/10 • From Week 0 to Week 44 Recorded AEs and SAEs may have multiple symptoms.