Trial Outcomes & Findings for A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis (NCT NCT04881461)
NCT ID: NCT04881461
Last Updated: 2024-12-16
Results Overview
The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
445 participants
Primary outcome timeframe
During the 2nd PGPS (14 days)
Results posted on
2024-12-16
Participant Flow
445 participants were randomized and treated. Participants were recruited from 45 sites in 6 countries (Czechia, Estonia, France, Latvia, Lithuania, and Poland).
Participant milestones
| Measure |
Placebo
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
5-grass Mix SLIT-drops
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
|---|---|---|
|
Overall Study
STARTED
|
223
|
222
|
|
Overall Study
COMPLETED
|
196
|
193
|
|
Overall Study
NOT COMPLETED
|
27
|
29
|
Reasons for withdrawal
| Measure |
Placebo
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
5-grass Mix SLIT-drops
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
19
|
19
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Reason stated as "other" in CRF
|
1
|
2
|
Baseline Characteristics
A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis
Baseline characteristics by cohort
| Measure |
Placebo
n=223 Participants
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
5-grass Mix SLIT-drops
n=222 Participants
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
Total
n=445 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.0 Years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
32.2 Years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
32.6 Years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
223 Participants
n=5 Participants
|
222 Participants
n=7 Participants
|
445 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
56 participants
n=5 Participants
|
57 participants
n=7 Participants
|
113 participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
France
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Latvia
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
117 participants
n=5 Participants
|
116 participants
n=7 Participants
|
233 participants
n=5 Participants
|
|
Ongoing asthma
|
63 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the 2nd PGPS (14 days)Population: Participants in the full analysis set.
The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.
Outcome measures
| Measure |
Placebo
n=192 Participants
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
5-grass Mix SLIT-drops
n=187 Participants
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
|---|---|---|
|
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Peak Grass Pollen Season (PGPS)
|
7.10 score on a scale
Standard Error 0.51
|
5.22 score on a scale
Standard Error 0.42
|
SECONDARY outcome
Timeframe: During the 2nd PGPS (14 days)Population: Participants in the full analysis set.
The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 2nd PGPS.
Outcome measures
| Measure |
Placebo
n=187 Participants
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
5-grass Mix SLIT-drops
n=182 Participants
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
|---|---|---|
|
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Peak Grass Pollen Season (PGPS)
|
1.04 score on a scale
Standard Error 0.08
|
0.86 score on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: During the 1st PGPS (14 days)Population: Participants in the full analysis set.
The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS.
Outcome measures
| Measure |
Placebo
n=207 Participants
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
5-grass Mix SLIT-drops
n=203 Participants
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
|---|---|---|
|
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Peak Grass Pollen Season (PGPS)
|
8.10 score on a scale
Standard Error 0.54
|
6.76 score on a scale
Standard Error 0.42
|
SECONDARY outcome
Timeframe: During the 1st PGPS (14 days)Population: Participants in the full analysis set.
The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 1st PGPS.
Outcome measures
| Measure |
Placebo
n=205 Participants
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
5-grass Mix SLIT-drops
n=197 Participants
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
|---|---|---|
|
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Peak Grass Pollen Season (PGPS)
|
1.26 score on a scale
Standard Error 0.09
|
1.19 score on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: During the 1st EGPS (observed mean duration of approximately 8 weeks)Population: Participants in the full analysis set.
The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 1st EGPS.
Outcome measures
| Measure |
Placebo
n=207 Participants
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
5-grass Mix SLIT-drops
n=205 Participants
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
|---|---|---|
|
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Entire Grass Pollen Season (EGPS)
|
1.16 score on a scale
Standard Error 0.09
|
1.09 score on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: During the 2nd EGPS (observed mean duration of approximately 9 weeks)Population: Participants in the full analysis set.
The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 2nd EGPS.
Outcome measures
| Measure |
Placebo
n=192 Participants
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
5-grass Mix SLIT-drops
n=190 Participants
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
|---|---|---|
|
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Entire Grass Pollen Season (EGPS)
|
1.03 score on a scale
Standard Error 0.08
|
0.83 score on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: During the 1st EGPS (observed mean duration of approximately 8 weeks)Population: Participants in the full analysis set.
The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS.
Outcome measures
| Measure |
Placebo
n=207 Participants
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
5-grass Mix SLIT-drops
n=205 Participants
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
|---|---|---|
|
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Entire Grass Pollen Season (EGPS)
|
7.42 score on a scale
Standard Error 0.54
|
6.23 score on a scale
Standard Error 0.45
|
SECONDARY outcome
Timeframe: During the 2nd EGPS (observed mean duration of approximately 9 weeks)Population: Participants in the full analysis set.
The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS.
Outcome measures
| Measure |
Placebo
n=193 Participants
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
5-grass Mix SLIT-drops
n=190 Participants
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
|---|---|---|
|
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Entire Grass Pollen Season (EGPS)
|
6.58 score on a scale
Standard Error 0.50
|
4.86 score on a scale
Standard Error 0.43
|
SECONDARY outcome
Timeframe: During the 1st PGPS (14 days)Population: Participants in the full analysis set.
The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS.
Outcome measures
| Measure |
Placebo
n=207 Participants
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
5-grass Mix SLIT-drops
n=203 Participants
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
|---|---|---|
|
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Peak Grass Pollen Season (PGPS)
|
4.08 score on a scale
Standard Error 0.27
|
3.83 score on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: During the 2nd PGPS (14 days)Population: Participants in the full analysis set.
The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.
Outcome measures
| Measure |
Placebo
n=192 Participants
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
5-grass Mix SLIT-drops
n=187 Participants
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
|---|---|---|
|
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Peak Grass Pollen Season (PGPS)
|
3.64 score on a scale
Standard Error 0.26
|
3.09 score on a scale
Standard Error 0.25
|
SECONDARY outcome
Timeframe: During the 1st EGPS (observed mean duration of approximately 8 weeks)Population: Participants in the full analysis set.
The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS.
Outcome measures
| Measure |
Placebo
n=207 Participants
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
5-grass Mix SLIT-drops
n=205 Participants
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
|---|---|---|
|
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Entire Grass Pollen Season (EGPS)
|
3.82 score on a scale
Standard Error 0.24
|
3.61 score on a scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: During the 2nd EGPS (observed mean duration of approximately 9 weeks)Population: Participants in the full analysis set.
The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS.
Outcome measures
| Measure |
Placebo
n=193 Participants
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
5-grass Mix SLIT-drops
n=190 Participants
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
|---|---|---|
|
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Entire Grass Pollen Season (EGPS)
|
3.46 score on a scale
Standard Error 0.23
|
2.89 score on a scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: During the 1st PGPS (14 days)Population: Participants in the full analysis set.
The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS.
Outcome measures
| Measure |
Placebo
n=207 Participants
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
5-grass Mix SLIT-drops
n=203 Participants
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
|---|---|---|
|
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Peak Grass Pollen Season (PGPS)
|
3.34 units on a scale
Standard Error 0.34
|
2.23 units on a scale
Standard Error 0.25
|
SECONDARY outcome
Timeframe: During the 2nd PGPS (14 days)Population: Participants in the full analysis set.
The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale of 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.
Outcome measures
| Measure |
Placebo
n=192 Participants
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
5-grass Mix SLIT-drops
n=187 Participants
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
|---|---|---|
|
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Peak Grass Pollen Season (PGPS)
|
2.77 score on a scale
Standard Error 0.30
|
1.52 score on a scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: During the 1st EGPS (observed mean duration of approximately 8 weeks)Population: Participants in the full analysis set.
The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication(on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS.
Outcome measures
| Measure |
Placebo
n=207 Participants
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
5-grass Mix SLIT-drops
n=205 Participants
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
|---|---|---|
|
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Entire Grass Pollen Season (EGPS)
|
3.04 score on a scale
Standard Error 0.35
|
2.10 score on a scale
Standard Error 0.27
|
SECONDARY outcome
Timeframe: During the 2nd EGPS (observed mean duration of approximately 9 weeks)Population: Participants in the full analysis set.
The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS.
Outcome measures
| Measure |
Placebo
n=193 Participants
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
5-grass Mix SLIT-drops
n=190 Participants
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.
|
|---|---|---|
|
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Entire Grass Pollen Season (EGPS)
|
2.62 score on a scale
Standard Error 0.31
|
1.51 score on a scale
Standard Error 0.23
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 111 other events
Deaths: 0 deaths
5-grass Mix SLIT-drops
Serious events: 4 serious events
Other events: 128 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=223 participants at risk
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed
|
5-grass Mix SLIT-drops
n=222 participants at risk
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed
|
|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.45%
1/223 • Number of events 1 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
0.45%
1/222 • Number of events 1 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/223 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
0.45%
1/222 • Number of events 1 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Infections and infestations
Diverticulitis
|
0.45%
1/223 • Number of events 1 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
0.00%
0/222 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Injury, poisoning and procedural complications
Gastrointestinal procedural complication
|
0.00%
0/223 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
0.45%
1/222 • Number of events 1 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.45%
1/223 • Number of events 1 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
0.00%
0/222 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.45%
1/223 • Number of events 1 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
0.00%
0/222 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/223 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
0.45%
1/222 • Number of events 1 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/223 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
0.45%
1/222 • Number of events 1 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/223 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
0.45%
1/222 • Number of events 1 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Product Issues
Device breakage
|
0.45%
1/223 • Number of events 1 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
0.00%
0/222 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Vascular disorders
Varicose vein
|
0.45%
1/223 • Number of events 1 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
0.00%
0/222 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
Other adverse events
| Measure |
Placebo
n=223 participants at risk
Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed
|
5-grass Mix SLIT-drops
n=222 participants at risk
Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed
|
|---|---|---|
|
Infections and infestations
COVID-19
|
19.3%
43/223 • Number of events 50 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
18.5%
41/222 • Number of events 44 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Infections and infestations
Nasopharyngitis
|
19.3%
43/223 • Number of events 75 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
17.1%
38/222 • Number of events 67 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Infections and infestations
Viral infection
|
3.1%
7/223 • Number of events 8 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
6.3%
14/222 • Number of events 15 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Infections and infestations
Influenza
|
4.9%
11/223 • Number of events 13 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
5.4%
12/222 • Number of events 12 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
15/223 • Number of events 20 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
4.5%
10/222 • Number of events 19 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Infections and infestations
Bronchitis
|
6.3%
14/223 • Number of events 15 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
3.2%
7/222 • Number of events 9 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Infections and infestations
Pharyngitis
|
9.0%
20/223 • Number of events 25 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
1.8%
4/222 • Number of events 4 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Gastrointestinal disorders
Oral pruritus
|
4.9%
11/223 • Number of events 12 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
18.0%
40/222 • Number of events 49 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.45%
1/223 • Number of events 1 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
6.8%
15/222 • Number of events 18 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Gastrointestinal disorders
Mouth swelling
|
0.00%
0/223 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
5.9%
13/222 • Number of events 15 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
1.8%
4/223 • Number of events 4 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
7.2%
16/222 • Number of events 16 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
|
Nervous system disorders
Headache
|
8.5%
19/223 • Number of events 30 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
5.0%
11/222 • Number of events 11 • Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
|
Additional Information
Senior Director, Clinical Data Science, Global Clinical Development
ALK-Abelló A/S
Phone: +4545747576
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No publication can be made before the first multi-center publication. PI shall allow Sponsor (S) no less than 60 days to review publications and presentations. S can comment and require removal of confidential information. Upon S request, PI must delay the publication or presentation for 6 months to permit S to file a patent application or take other steps to protect S' information. Any other public statements regarding the trial requires prior written consent from S.
- Publication restrictions are in place
Restriction type: OTHER