Trial Outcomes & Findings for Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of 300 IR Sublingual Immunotherapy Tablets (NCT NCT00418379)
NCT ID: NCT00418379
Last Updated: 2016-05-25
Results Overview
The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use. Participants assessed daily, during the Year 3 pollen period while on treatment, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
633 participants
Primary outcome timeframe
Pollen period (average of 33.8 days) of Year 3
Results posted on
2016-05-25
Participant Flow
First Patient First Visit 08 DEC 2006, Last Patient Last Visit 07 SEP 2011
Participant milestones
| Measure |
300 IR (4M)
300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
|
300 IR (2M)
300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
|
Placebo
Placebo tablet
|
|---|---|---|---|
|
Year 1
STARTED
|
207
|
207
|
219
|
|
Year 1
COMPLETED
|
189
|
179
|
204
|
|
Year 1
NOT COMPLETED
|
18
|
28
|
15
|
|
Year 2
STARTED
|
167
|
159
|
182
|
|
Year 2
COMPLETED
|
159
|
155
|
172
|
|
Year 2
NOT COMPLETED
|
8
|
4
|
10
|
|
Year 3
STARTED
|
151
|
148
|
166
|
|
Year 3
COMPLETED
|
148
|
146
|
163
|
|
Year 3
NOT COMPLETED
|
3
|
2
|
3
|
|
Year 4
STARTED
|
145
|
141
|
156
|
|
Year 4
COMPLETED
|
142
|
136
|
154
|
|
Year 4
NOT COMPLETED
|
3
|
5
|
2
|
|
Year 5
STARTED
|
128
|
120
|
134
|
|
Year 5
COMPLETED
|
126
|
115
|
131
|
|
Year 5
NOT COMPLETED
|
2
|
5
|
3
|
Reasons for withdrawal
| Measure |
300 IR (4M)
300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
|
300 IR (2M)
300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
|
Placebo
Placebo tablet
|
|---|---|---|---|
|
Year 1
Adverse Event
|
9
|
15
|
3
|
|
Year 1
Withdrawal by Subject
|
7
|
8
|
5
|
|
Year 1
Any other reason not above-mentioned
|
2
|
5
|
7
|
|
Year 2
Adverse Event
|
5
|
2
|
1
|
|
Year 2
Withdrawal by Subject
|
1
|
1
|
3
|
|
Year 2
Any other reason not above-mentioned
|
2
|
1
|
6
|
|
Year 3
Withdrawal by Subject
|
1
|
1
|
2
|
|
Year 3
Any other reason not above-mentioned
|
2
|
1
|
1
|
|
Year 4
Adverse Event
|
0
|
1
|
0
|
|
Year 4
Withdrawal by Subject
|
2
|
3
|
2
|
|
Year 4
Any other reason not above-mentioned
|
1
|
1
|
0
|
|
Year 5
Adverse Event
|
0
|
1
|
0
|
|
Year 5
Any other reason not above-mentioned
|
2
|
4
|
3
|
Baseline Characteristics
Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of 300 IR Sublingual Immunotherapy Tablets
Baseline characteristics by cohort
| Measure |
300 IR (4M)
n=188 Participants
300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
|
300 IR (2M)
n=188 Participants
300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
|
Placebo
n=205 Participants
Placebo tablet
|
Total
n=581 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
30.9 years
STANDARD_DEVIATION 8.25 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 7.57 • n=7 Participants
|
30.2 years
STANDARD_DEVIATION 8.56 • n=5 Participants
|
30.5 years
STANDARD_DEVIATION 8.14 • n=4 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
226 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
355 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pollen period (average of 33.8 days) of Year 3Population: Full Analysis Set Year 3 (FASY3). FASY3 included all patients who received at least one dose of the investigational product and had at least one Adjusted Symptom Score (AdSS) during the pollen period while on treatment during the Year 3.
The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use. Participants assessed daily, during the Year 3 pollen period while on treatment, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome.
Outcome measures
| Measure |
300 IR (4M)
n=149 Participants
300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
|
300 IR (2M)
n=147 Participants
300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
|
Placebo
n=165 Participants
Placebo tablet
|
|---|---|---|---|
|
Average Adjusted Symptom Score (AAdSS)
|
3.39 Units on a scale (range: 0 to 18)
Standard Error 0.357
|
3.25 Units on a scale (range: 0 to 18)
Standard Error 0.369
|
5.21 Units on a scale (range: 0 to 18)
Standard Error 0.348
|
Adverse Events
300 IR (4M)
Serious events: 9 serious events
Other events: 179 other events
Deaths: 0 deaths
300 IR (2M)
Serious events: 7 serious events
Other events: 167 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 170 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
300 IR (4M)
n=207 participants at risk
300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
|
300 IR (2M)
n=207 participants at risk
300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
|
Placebo
n=219 participants at risk
Placebo tablet
|
|---|---|---|---|
|
Infections and infestations
APPENDICITIS
|
0.48%
1/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Infections and infestations
DIARRHOEA
|
0.48%
1/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Infections and infestations
HEPATITIS B
|
0.00%
0/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.46%
1/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Infections and infestations
GENITAL INFECTION
|
0.48%
1/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Injury, poisoning and procedural complications
CERVICAL VERTEBRAL FRACTURE
|
0.48%
1/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.00%
0/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.46%
1/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.48%
1/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Injury, poisoning and procedural complications
MENISCUS LESION
|
0.00%
0/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.48%
1/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN NEOPLASM OF CERVIX UTERI
|
0.00%
0/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.48%
1/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TESTICULAR GERM CELL TUMOUR MIXED STAGE I
|
0.00%
0/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.48%
1/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Congenital, familial and genetic disorders
FAMILIAL MEDITERRANEAN FEVER
|
0.48%
1/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.48%
1/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.48%
1/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Pregnancy, puerperium and perinatal conditions
ECTOPIC PREGNANCY
|
0.48%
1/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Skin and subcutaneous tissue disorders
ANGIOEDEMA
|
0.48%
1/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.00%
0/167 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/159 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.55%
1/182 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Injury, poisoning and procedural complications
SPINAL COLUMN INJURY
|
0.60%
1/167 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/159 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/182 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Musculoskeletal and connective tissue disorders
ARTHROPATHY
|
0.00%
0/167 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.63%
1/159 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/182 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Surgical and medical procedures
ABORTION INDUCED
|
0.00%
0/167 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.63%
1/159 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/182 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Injury, poisoning and procedural complications
EYE INJURY
|
0.66%
1/151 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/148 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/166 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.00%
0/151 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.68%
1/148 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/166 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/151 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/148 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.60%
1/166 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/151 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.68%
1/148 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/166 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Renal and urinary disorders
RENAL COLIC
|
0.00%
0/151 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/148 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.60%
1/166 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/151 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.00%
0/148 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.60%
1/166 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
Other adverse events
| Measure |
300 IR (4M)
n=207 participants at risk
300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
|
300 IR (2M)
n=207 participants at risk
300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
|
Placebo
n=219 participants at risk
Placebo tablet
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
THROAT IRRITATION
|
33.8%
70/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
29.0%
60/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
9.1%
20/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
17.4%
36/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
16.9%
35/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
18.7%
41/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
16.9%
35/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
15.9%
33/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
17.4%
38/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DISCOMFORT
|
13.0%
27/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
13.5%
28/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
16.9%
37/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
12.6%
26/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
12.6%
26/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
15.1%
33/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
15.0%
31/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
15.9%
33/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
15.5%
34/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
8.7%
18/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
9.2%
19/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
5.9%
13/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
5.8%
12/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
10.1%
21/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
6.4%
14/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Gastrointestinal disorders
ORAL PRURITUS
|
51.7%
107/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
43.0%
89/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
14.6%
32/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Gastrointestinal disorders
OEDEMA MOUTH
|
12.6%
26/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
8.2%
17/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
1.4%
3/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
6.3%
13/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
4.8%
10/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.46%
1/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Eye disorders
EYE PRURITUS
|
14.5%
30/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
15.9%
33/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
17.8%
39/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Eye disorders
LACRIMATION INCREASED
|
7.7%
16/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
10.6%
22/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
12.8%
28/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Eye disorders
CONJUNCTIVITIS ALLERGIC
|
5.3%
11/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
6.8%
14/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
9.6%
21/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Eye disorders
CONJUNCTIVITIS
|
6.8%
14/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
8.2%
17/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
5.9%
13/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Infections and infestations
NASOPHARYNGITIS
|
20.3%
42/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
12.6%
26/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
21.0%
46/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Infections and infestations
RHINITIS
|
7.7%
16/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
7.7%
16/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
5.9%
13/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Nervous system disorders
HEADACHE
|
11.1%
23/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
13.5%
28/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
21.0%
46/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Ear and labyrinth disorders
EAR PRURITUS
|
15.5%
32/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
7.2%
15/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
2.3%
5/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
6.8%
14/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
5.8%
12/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
7.8%
17/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL OEDEMA
|
5.3%
11/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
5.3%
11/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.91%
2/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Gastrointestinal disorders
ORAL DISCOMFORT
|
6.3%
13/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
5.8%
12/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
1.4%
3/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Gastrointestinal disorders
GLOSSODYNIA
|
5.3%
11/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
3.9%
8/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.46%
1/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Gastrointestinal disorders
PARAESTHESIA ORAL
|
5.3%
11/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
2.9%
6/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
0.46%
1/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Infections and infestations
PHARYNGITIS
|
4.8%
10/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
7.7%
16/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
8.7%
19/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Infections and infestations
INFLUENZA
|
5.8%
12/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
3.4%
7/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
5.9%
13/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Immune system disorders
SEASONAL ALLERGY
|
5.3%
11/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
4.8%
10/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
6.8%
15/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.4%
7/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
3.4%
7/207 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
5.5%
12/219 • Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
|
Additional Information
Laurence Paolozzi, Medical Director
Stallergenes
Phone: +33 (0) 1 55 59 26 33
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place