## Protocol Section
### Identification Module
**NCT ID:** NCT00418379

**Brief Title:** Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of 300 IR Sublingual Immunotherapy Tablets

**Official Title:** A Randomised, Double-blind, Placebo-controlled, Multi-national, Multi-centre, Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of Two Dosing Regimens of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis

#### Organization Study ID Info
**ID:** VO53.06
#### Organization
**Class:** INDUSTRY
**Full Name:** Stallergenes Greer
### Status Module
#### Completion Date
**Date:** 2011-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-05-25

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-04-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-08

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2016-05-25

**Type:** ESTIMATED

**Results First Submit Date:** 2016-01-25

**Results First Submit QC Date:** 2016-04-18

#### Start Date
**Date:** 2006-12

**Status Verified Date:** 2016-04

#### Study First Post Date
**Date:** 2007-01-04
**Type:** ESTIMATED
**Study First Submit Date:** 2007-01-03
**Study First Submit QC Date:** 2007-01-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Stallergenes Greer

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** A phase III study to evaluate Long term efficacy , carry-over effect and safety of 300 IR sublingual Immunotherapy (SLIT) tablets in adults patients suffering from grass pollen rhinoconjunctivitis

### Conditions Module

**Conditions:**

- Allergy

**Keywords:**

- Sublingual immunotherapy

- Grass pollen tablet

- Allergic rhinoconjunctivitis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 633

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season

**Intervention Names:**

- Drug: 300 IR (4M)

**Label:** 300 IR (4M)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season

**Intervention Names:**

- Drug: 300 IR (2M)

**Label:** 300 IR (2M)

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Placebo tablet

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 300 IR (4M)

**Description:** 300 IR grass pollen allergen extract tablet starting 4 months before the pollen season

**Name:** 300 IR (4M)

**Other Names:**

- Sublingual immunotherapy tablet

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 300 IR (2M)

**Description:** 300 IR grass pollen allergen extract tablet starting 2 months before the pollen season

**Name:** 300 IR (2M)

**Other Names:**

- Sublingual immunotherapy tablet

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Placebo

**Description:** Placebo tablet

**Name:** Placebo

**Other Names:**

- Sublingual placebo tablet

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Average Adjusted Symptom Score (AAdSS)

**Time Frame:** Pollen period (average of 33.8 days) of Year 3

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or female outpatients aged 18 to 50 years
* Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons
* Positive SPT and specific IgE values of at least Class 2 for grass pollen allergens
* A score of greater than or equal to 12 out of a possible 18 on the Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS)

Exclusion Criteria:

* Patients with symptoms of rhinoconjunctivitis during the grass pollen season due to sensitisation to allergens other than grass pollen must not be included. Patients must be asymptomatic to all other allergens during the grass pollen season. Patients who have allergic rhinitis due to perennial allergen may not be included.
* Asthma requiring treatment other than beta-2 inhaled agonists.
* Patients who have received any desensitisation treatment for grass pollen or with any other allergen within the previous 5 years.

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Toulouse

**Country:** France

**Facility:** DIDIER

**Zip:** 31400

#### Overall Officials

**Official 1:**

**Affiliation:** Hôpital Rangueil-Larrey, Toulouse, France

**Name:** Alain DIDIER, MD, Pr

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Didier A, Worm M, Horak F, Sussman G, de Beaumont O, Le Gall M, Melac M, Malling HJ. Sustained 3-year efficacy of pre- and coseasonal 5-grass-pollen sublingual immunotherapy tablets in patients with grass pollen-induced rhinoconjunctivitis. J Allergy Clin Immunol. 2011 Sep;128(3):559-66. doi: 10.1016/j.jaci.2011.06.022. Epub 2011 Jul 29.

**PMID:** 21802126

**Citation:** Didier A, Malling HJ, Worm M, Horak F, Sussman G, Melac M, Soulie S, Zeldin RK. Post-treatment efficacy of discontinuous treatment with 300IR 5-grass pollen sublingual tablet in adults with grass pollen-induced allergic rhinoconjunctivitis. Clin Exp Allergy. 2013 May;43(5):568-77. doi: 10.1111/cea.12100.

**PMID:** 23600548

**Citation:** Didier A, Malling HJ, Worm M, Horak F, Sussman GL. Prolonged efficacy of the 300IR 5-grass pollen tablet up to 2 years after treatment cessation, as measured by a recommended daily combined score. Clin Transl Allergy. 2015 May 22;5:12. doi: 10.1186/s13601-015-0057-8. eCollection 2015.

**PMID:** 26097680

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M2853

- Name: Immunomodulating Agents

- Relevance: HIGH

- As Found: Computer

- ID: M10201

- Name: Immunologic Factors

- Relevance: HIGH

- As Found: Computer

### Intervention Browse Module - Meshes

- ID: D000091369

- Term: Immunomodulating Agents

- ID: D000007155

- Term: Immunologic Factors

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** 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.

#### Event Groups

**Group ID:** EG000

**Title:** 300 IR (4M)

**Description:** 300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season

**ID:** EG000

**Other Num Affected:** 179

**Other Num at Risk:** 207

**Serious Number Affected:** 9

**Serious Number At Risk:** 207

**Title:** 300 IR (4M)

**Group ID:** EG001

**Title:** 300 IR (2M)

**Description:** 300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season

**ID:** EG001

**Other Num Affected:** 167

**Other Num at Risk:** 207

**Serious Number Affected:** 7

**Serious Number At Risk:** 207

**Title:** 300 IR (2M)

**Group ID:** EG002

**Title:** Placebo

**Description:** Placebo tablet

**ID:** EG002

**Other Num Affected:** 170

**Other Num at Risk:** 219

**Serious Number Affected:** 6

**Serious Number At Risk:** 219

**Title:** Placebo

**Frequency Threshold:** 5

#### Other Events

**Term:** THROAT IRRITATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** SNEEZING

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** RHINORRHOEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** NASAL DISCOMFORT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** NASAL CONGESTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** COUGH

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** PHARYNGOLARYNGEAL PAIN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** RHINITIS ALLERGIC

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** ORAL PRURITUS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** OEDEMA MOUTH

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** DYSPEPSIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** EYE PRURITUS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** LACRIMATION INCREASED

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** CONJUNCTIVITIS ALLERGIC

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** CONJUNCTIVITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** NASOPHARYNGITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** RHINITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** HEADACHE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** EAR PRURITUS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** ASTHMA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** PHARYNGEAL OEDEMA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** ORAL DISCOMFORT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** GLOSSODYNIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** PARAESTHESIA ORAL

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** PHARYNGITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** INFLUENZA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** SEASONAL ALLERGY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA Version 9.1.

**Term:** BACK PAIN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 9.1.

#### Serious Events

**Term:** APPENDICITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 207

**Group ID:** EG001

**Num At Risk:** 207

**Group ID:** EG002

**Num At Risk:** 219

**Term:** DIARRHOEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 207

**Group ID:** EG001

**Num At Risk:** 207

**Group ID:** EG002

**Num At Risk:** 219

**Term:** HEPATITIS B

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num At Risk:** 207

**Group ID:** EG001

**Num At Risk:** 207

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 219

**Term:** GENITAL INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 207

**Group ID:** EG001

**Num At Risk:** 207

**Group ID:** EG002

**Num At Risk:** 219

**Term:** CERVICAL VERTEBRAL FRACTURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 207

**Group ID:** EG001

**Num At Risk:** 207

**Group ID:** EG002

**Num At Risk:** 219

**Term:** LOWER LIMB FRACTURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num At Risk:** 207

**Group ID:** EG001

**Num At Risk:** 207

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 219

**Term:** CONTUSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 207

**Group ID:** EG001

**Num At Risk:** 207

**Group ID:** EG002

**Num At Risk:** 219

**Term:** MENISCUS LESION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num At Risk:** 207

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 207

**Group ID:** EG002

**Num At Risk:** 219

**Term:** BENIGN NEOPLASM OF CERVIX UTERI

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num At Risk:** 207

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 207

**Group ID:** EG002

**Num At Risk:** 219

**Term:** TESTICULAR GERM CELL TUMOUR MIXED STAGE I

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num At Risk:** 207

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 207

**Group ID:** EG002

**Num At Risk:** 219

**Term:** FAMILIAL MEDITERRANEAN FEVER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Congenital, familial and genetic disorders

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 207

**Group ID:** EG001

**Num At Risk:** 207

**Group ID:** EG002

**Num At Risk:** 219

**Term:** HYPERSENSITIVITY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 207

**Group ID:** EG001

**Num At Risk:** 207

**Group ID:** EG002

**Num At Risk:** 219

**Term:** INTERVERTEBRAL DISC PROTRUSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 207

**Group ID:** EG001

**Num At Risk:** 207

**Group ID:** EG002

**Num At Risk:** 219

**Term:** ECTOPIC PREGNANCY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Pregnancy, puerperium and perinatal conditions

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 207

**Group ID:** EG001

**Num At Risk:** 207

**Group ID:** EG002

**Num At Risk:** 219

**Term:** ANGIOEDEMA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 207

**Group ID:** EG001

**Num At Risk:** 207

**Group ID:** EG002

**Num At Risk:** 219

**Term:** CONCUSSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num At Risk:** 167

**Group ID:** EG001

**Num At Risk:** 159

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 182

**Term:** SPINAL COLUMN INJURY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 167

**Group ID:** EG001

**Num At Risk:** 159

**Group ID:** EG002

**Num At Risk:** 182

**Term:** ARTHROPATHY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num At Risk:** 167

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 159

**Group ID:** EG002

**Num At Risk:** 182

**Term:** ABORTION INDUCED

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num At Risk:** 167

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 159

**Group ID:** EG002

**Num At Risk:** 182

**Term:** EYE INJURY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 151

**Group ID:** EG001

**Num At Risk:** 148

**Group ID:** EG002

**Num At Risk:** 166

**Term:** LIGAMENT SPRAIN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num At Risk:** 151

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 148

**Group ID:** EG002

**Num At Risk:** 166

**Term:** GASTROENTERITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num At Risk:** 151

**Group ID:** EG001

**Num At Risk:** 148

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 166

**Term:** ROAD TRAFFIC ACCIDENT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num At Risk:** 151

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 148

**Group ID:** EG002

**Num At Risk:** 166

**Term:** RENAL COLIC

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num At Risk:** 151

**Group ID:** EG001

**Num At Risk:** 148

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 166

**Term:** ASTHMA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 9.1.

##### Stats

**Group ID:** EG000

**Num At Risk:** 151

**Group ID:** EG001

**Num At Risk:** 148

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 166

**Time Frame:** Over 3 years during the treatment periods .

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 188

**Group ID:** BG001

**Value:** 188

**Group ID:** BG002

**Value:** 205

**Group ID:** BG003

**Value:** 581

**Units:** Participants

### Group

**ID:** BG000

**Title:** 300 IR (4M)

**Description:** 300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season

### Group

**ID:** BG001

**Title:** 300 IR (2M)

**Description:** 300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season

### Group

**ID:** BG002

**Title:** Placebo

**Description:** Placebo tablet

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 8.25

**Value:** 30.9

#### Measurement

**Group ID:** BG001

**Spread:** 7.57

**Value:** 30.4

#### Measurement

**Group ID:** BG002

**Spread:** 8.56

**Value:** 30.2

#### Measurement

**Group ID:** BG003

**Spread:** 8.14

**Value:** 30.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 66

#### Measurement

**Group ID:** BG001

**Value:** 77

#### Measurement

**Group ID:** BG002

**Value:** 83

#### Measurement

**Group ID:** BG003

**Value:** 226

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 122

#### Measurement

**Group ID:** BG001

**Value:** 111

#### Measurement

**Group ID:** BG002

**Value:** 122

#### Measurement

**Group ID:** BG003

**Value:** 355

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
**Population Description:** Full Analysis Set Year 1 (FASY1). FASY1 included all patients who received at least one dose of the investigational product and had at least one Adjusted Symptom Score (ASS) during the pollen period while on treatment during the Year 1.
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** lpaolozzi@stallergenes.com
**Organization:** Stallergenes
**Phone:** +33 (0) 1 55 59 26 33
**Title:** Laurence Paolozzi, Medical Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** < 0.0001
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** < 0.0001
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.357
- **Upper Limit:** 
- **Value:** 3.39
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.369
- **Upper Limit:** 
- **Value:** 3.25
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.348
- **Upper Limit:** 
- **Value:** 5.21
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Pollen period (average of 33.8 days) of Year 3
**Title:** Average Adjusted Symptom Score (AAdSS)
**Type:** PRIMARY
**Unit of Measure:** Units on a scale (range: 0 to 18)
##### Group
**Description:** 300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
**ID:** OG000
**Title:** 300 IR (4M)
##### Group
**Description:** 300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
**ID:** OG001
**Title:** 300 IR (2M)
##### Group
**Description:** Placebo tablet
**ID:** OG002
**Title:** Placebo
### Participant Flow Module
#### Group
**Description:** 300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
**ID:** FG000
**Title:** 300 IR (4M)
#### Group
**Description:** 300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
**ID:** FG001
**Title:** 300 IR (2M)
#### Group
**Description:** Placebo tablet
**ID:** FG002
**Title:** Placebo
#### Period
**Title:** Year 1
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 9
###### Reason
**Group ID:** FG001
**Number of Subjects:** 15
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
###### Reason
**Group ID:** FG001
**Number of Subjects:** 8
###### Reason
**Group ID:** FG002
**Number of Subjects:** 5
##### Withdraw
**Type:** Any other reason not above-mentioned
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
###### Reason
**Group ID:** FG002
**Number of Subjects:** 7
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 207
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 207
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 219
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 189
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 179
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 204
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 18
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 28
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 15
#### Period
**Title:** Year 2
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
##### Withdraw
**Type:** Any other reason not above-mentioned
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 6
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 167
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 159
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 182
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 159
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 155
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 172
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 10
#### Period
**Title:** Year 3
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
##### Withdraw
**Type:** Any other reason not above-mentioned
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 151
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 148
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 166
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 148
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 146
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 163
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 3
#### Period
**Title:** Year 4
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
##### Withdraw
**Type:** Any other reason not above-mentioned
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 145
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 141
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 156
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 142
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 136
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 154
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 2
#### Period
**Title:** Year 5
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Any other reason not above-mentioned
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 128
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 120
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 134
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 126
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 115
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 131
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 3
**Recruitment Details:** First Patient First Visit 08 DEC 2006, Last Patient Last Visit 07 SEP 2011
**Has Results:** True