| Primary | Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Peak Grass Pollen Season (PGPS) | The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS. | Participants in the full analysis set. | Posted | | Mean | Standard Error | score on a scale | | During the 2nd PGPS (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. | | OG001 | 5-grass Mix SLIT-drops | Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0007.10± 0.51
- OG0015.22± 0.42
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The null hypothesis was defined as "no difference in means between treatment arms". The endpoint analysis was based on a 5% significance level. The trial was designed to have 86% power for the primary endpoint using the primary (trial product) estimand. | Mixed Models Analysis | Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction | 0.0036 | | Mean Difference (Final Values) | 1.88 | | | 2-Sided | 95 | 0.60 | 3.17 | | | Placebo vs 5-grass mix SLIT-drops | | |
|
| Secondary | Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Peak Grass Pollen Season (PGPS) | The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 2nd PGPS. | Participants in the full analysis set. | Posted | | Mean | Standard Error | score on a scale | | During the 2nd PGPS (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. | | OG001 | 5-grass Mix SLIT-drops | Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. |
| |
| Secondary | Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Peak Grass Pollen Season (PGPS) | The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS. | Participants in the full analysis set. | Posted | | Mean | Standard Error | score on a scale | | During the 1st PGPS (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. | | OG001 | 5-grass Mix SLIT-drops | Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. |
| |
| Secondary | Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Peak Grass Pollen Season (PGPS) | The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 1st PGPS. | Participants in the full analysis set. | Posted | | Mean | Standard Error | score on a scale | | During the 1st PGPS (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. | | OG001 | 5-grass Mix SLIT-drops | Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. |
| |
| Secondary | Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Entire Grass Pollen Season (EGPS) | The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 1st EGPS. | Participants in the full analysis set. | Posted | | Mean | Standard Error | score on a scale | | During the 1st EGPS (observed mean duration of approximately 8 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. | | OG001 | 5-grass Mix SLIT-drops | Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. |
| |
| Secondary | Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Entire Grass Pollen Season (EGPS) | The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 2nd EGPS. | Participants in the full analysis set. | Posted | | Mean | Standard Error | score on a scale | | During the 2nd EGPS (observed mean duration of approximately 9 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. | | OG001 | 5-grass Mix SLIT-drops | Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. |
| |
| Secondary | Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Entire Grass Pollen Season (EGPS) | The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS. | Participants in the full analysis set. | Posted | | Mean | Standard Error | score on a scale | | During the 1st EGPS (observed mean duration of approximately 8 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. | | OG001 | 5-grass Mix SLIT-drops | Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. |
| |
| Secondary | Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Entire Grass Pollen Season (EGPS) | The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS. | Participants in the full analysis set. | Posted | | Mean | Standard Error | score on a scale | | During the 2nd EGPS (observed mean duration of approximately 9 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. | | OG001 | 5-grass Mix SLIT-drops | Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. |
| |
| Secondary | Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Peak Grass Pollen Season (PGPS) | The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS. | Participants in the full analysis set. | Posted | | Mean | Standard Error | score on a scale | | During the 1st PGPS (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. | | OG001 | 5-grass Mix SLIT-drops | Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. |
| |
| Secondary | Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Peak Grass Pollen Season (PGPS) | The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS. | Participants in the full analysis set. | Posted | | Mean | Standard Error | score on a scale | | During the 2nd PGPS (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. | | OG001 | 5-grass Mix SLIT-drops | Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. |
| |
| Secondary | Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Entire Grass Pollen Season (EGPS) | The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS. | Participants in the full analysis set. | Posted | | Mean | Standard Error | score on a scale | | During the 1st EGPS (observed mean duration of approximately 8 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. | | OG001 | 5-grass Mix SLIT-drops | Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. |
| |
| Secondary | Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Entire Grass Pollen Season (EGPS) | The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS. | Participants in the full analysis set. | Posted | | Mean | Standard Error | score on a scale | | During the 2nd EGPS (observed mean duration of approximately 9 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. | | OG001 | 5-grass Mix SLIT-drops | Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. |
| |
| Secondary | Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Peak Grass Pollen Season (PGPS) | The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS. | Participants in the full analysis set. | Posted | | Mean | Standard Error | units on a scale | | During the 1st PGPS (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. | | OG001 | 5-grass Mix SLIT-drops | Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. |
| |
| Secondary | Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Peak Grass Pollen Season (PGPS) | The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale of 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS. | Participants in the full analysis set. | Posted | | Mean | Standard Error | score on a scale | | During the 2nd PGPS (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. | | OG001 | 5-grass Mix SLIT-drops | Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. |
| |
| Secondary | Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Entire Grass Pollen Season (EGPS) | The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication(on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS. | Participants in the full analysis set. | Posted | | Mean | Standard Error | score on a scale | | During the 1st EGPS (observed mean duration of approximately 8 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. | | OG001 | 5-grass Mix SLIT-drops | Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. |
| |
| Secondary | Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Entire Grass Pollen Season (EGPS) | The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS. | Participants in the full analysis set. | Posted | | Mean | Standard Error | score on a scale | | During the 2nd EGPS (observed mean duration of approximately 9 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. | | OG001 | 5-grass Mix SLIT-drops | Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. |
| |