Trial Outcomes & Findings for Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and Children (NCT NCT01199133)

NCT ID: NCT01199133

Last Updated: 2025-02-11

Results Overview

The primary efficacy endpoint was the Average Adjusted Symptom Score (AAdSS) during the period from 1 October 2010 to 30 November 2010 (Year 1 Primary Period) assessed in the Full Analysis Set defined for Year 1. The Average Adjusted Symptom Score (AAdSS) ranges from 0 to 12, with a higher score meaning a worse outcome. It is a score assessing four rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, adjusted on the rescue medication intake

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

471 participants

Primary outcome timeframe

Year 1 Primary Period = 01 OCT to 30 NOV 2010 The value was obtained by averaging the daily scores over the primary period

Results posted on

2025-02-11

Participant Flow

First Patient First Visit 27 OCT 2009, Last Patient Last Visit 30 SEP 2011

Participant milestones

Participant milestones
Measure	300 IR 300 IR house dust mites allergen extract tablet	Placebo Placebo tablet
Year 1 STARTED	241	230
Year 1 COMPLETED	211	215
Year 1 NOT COMPLETED	30	15
Year 2 STARTED	211	215
Year 2 COMPLETED	208	212
Year 2 NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	300 IR 300 IR house dust mites allergen extract tablet	Placebo Placebo tablet
Year 1 Adverse Event	16	4
Year 1 Withdrawal by Subject	8	4
Year 1 Any other reason not above-mentioned	6	7
Year 2 Adverse Event	1	0
Year 2 Withdrawal by Subject	1	1
Year 2 Any other reason not above-mentioned	1	2

Baseline Characteristics

Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	300 IR n=222 Participants 300 IR house dust mites allergen extract tablet	Placebo n=221 Participants Placebo tablet	Total n=443 Participants Total of all reporting groups
Age, Continuous	11.0 years STANDARD_DEVIATION 3.24 • n=5 Participants	11.2 years STANDARD_DEVIATION 3.41 • n=7 Participants	11.1 years STANDARD_DEVIATION 3.32 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	81 Participants n=7 Participants	156 Participants n=5 Participants
Sex: Female, Male Male	147 Participants n=5 Participants	140 Participants n=7 Participants	287 Participants n=5 Participants

PRIMARY outcome

Timeframe: Year 1 Primary Period = 01 OCT to 30 NOV 2010 The value was obtained by averaging the daily scores over the primary period

Population: The Full Analysis Set included all randomized patients who received at least one dose of study treatment and had at least one evaluation of Adjusted Symptom Score (AdSS) during the treatment Year 1 period.

Outcome measures

Outcome measures
Measure	300 IR n=222 Participants 300 IR house dust mites allergen extract tablet	Placebo n=221 Participants Placebo tablet
Average Adjusted Symptom Score (AASS) During the Treatment Period	2.85 units on a scale Standard Error 0.160	2.84 units on a scale Standard Error 0.155

Adverse Events

300 IR

Serious events: 8 serious events

Other events: 149 other events

Deaths: 0 deaths

Placebo

Serious events: 7 serious events

Other events: 124 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	300 IR n=241 participants at risk 300 IR house dust mites allergen extract tablet	Placebo n=230 participants at risk Placebo tablet
Injury, poisoning and procedural complications Concussion	0.41% 1/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	0.00% 0/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Injury, poisoning and procedural complications Radius fracture	0.41% 1/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	0.00% 0/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	0.43% 1/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Injury, poisoning and procedural complications Ligament injury	0.00% 0/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	0.43% 1/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Respiratory, thoracic and mediastinal disorders Asthma	0.83% 2/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	0.00% 0/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.00% 0/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	0.43% 1/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Infections and infestations Appendicitis	0.41% 1/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	0.00% 0/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Infections and infestations Gastroenteritis salmonella	0.41% 1/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	0.00% 0/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Gastrointestinal disorders Umbilical hernia	0.41% 1/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	0.00% 0/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Surgical and medical procedures Abortion induced	0.41% 1/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	0.00% 0/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Psychiatric disorders Adjustment disorder	0.00% 0/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	0.43% 1/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Psychiatric disorders Suicide attempt	0.00% 0/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	0.43% 1/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Nervous system disorders Epilepsy	0.00% 0/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	0.43% 1/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Reproductive system and breast disorders Varicocele	0.00% 0/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	0.43% 1/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.

Other adverse events

Other adverse events
Measure	300 IR n=241 participants at risk 300 IR house dust mites allergen extract tablet	Placebo n=230 participants at risk Placebo tablet
Respiratory, thoracic and mediastinal disorders Cough	12.9% 31/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	15.7% 36/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Respiratory, thoracic and mediastinal disorders Asthma	12.4% 30/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	13.0% 30/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Respiratory, thoracic and mediastinal disorders Throat irritation	10.0% 24/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	2.6% 6/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Infections and infestations Pharyngitis	9.5% 23/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	9.1% 21/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Infections and infestations Bronchitis	9.1% 22/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	12.2% 28/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Infections and infestations Tonsillitis	5.8% 14/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	1.7% 4/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Infections and infestations Upper respiratory tract infection	5.4% 13/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	3.9% 9/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Infections and infestations Nasopharyngitis	4.1% 10/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	6.5% 15/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Gastrointestinal disorders Oral pruritus	11.2% 27/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	3.0% 7/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Gastrointestinal disorders Abdominal pain	5.8% 14/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	1.7% 4/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Gastrointestinal disorders Tooth loss	5.4% 13/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	3.5% 8/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Gastrointestinal disorders Tongue oedema	5.4% 13/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	0.00% 0/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Nervous system disorders Headache	8.7% 21/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	10.0% 23/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
General disorders Pyrexia	2.1% 5/241 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.	8.3% 19/230 • Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months. Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.

Additional Information

Michel Roux, Medical Director

Stallergenes

Phone: +33 (0) 1 55 59 29 70

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place