| Primary | Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days) | Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). Total score ranges from 0 to 15. | Number of participants from the Intent to treat (ITT) population with available T5SS over the Total Treatment Period | Posted | | Mean | Standard Deviation | points on a scale | | Over the total treatment period (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0008.68± 3.44
- OG0017.87± 3.17
|
|
| | 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 |
|---|
| The Null Hypothesis for the primary endpoint is expressed as follows: 'The mean 24-hr reflective T5SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.' | ANCOVA | ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate. | <0.001 | If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups. | Mean Difference (Final Values) | -0.89 | | | | 95 | -1.33 | -0.45 | | | The difference presented is 'Levocetirizine 5 mg - Placebo' | No |
|
| Secondary | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. | Number of participants from the ITT population with available overall RQLQ score at Endpoint visit and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and at endpoint of the 2 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1 | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6. | Number of participants from the ITT population with available RQLQ overall score at Visit 3 (Week 1) and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2 | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6. | Number of participants from the ITT population with available overall RQLQ score at Visit 4 (Week 2) and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. | Number of participants from the ITT population with available RQLQ activities score at Endpoint visit and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and at endpoint of the 2 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1 | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. | Number of participants from the ITT population with available RQLQ activities score at Visit 3 (Week 1) and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2 | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. | Number of participants from the ITT population with available RQLQ activities score at Visit 4 (Week 2) and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. | Number of participants from the ITT population with available RQLQ sleep score at Endpoint visit and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and at endpoint of the 2 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1 | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. | Number of participants from the ITT population with available RQLQ sleep score at Visit 3 (Week 1) and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2 | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. | Number of participants from the ITT population with available RQLQ sleep score at Visit 4 (Week 2) and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Endpoint During the Two-week Treatment Period | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. | Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Endpoint visit and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and at endpoint of the 2 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1 | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. | Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Visit 3 (Week 1) and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2 | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. | Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Visit 4 (Week 2) and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Endpoint During the Two-week Treatment Period | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. | Number of participants from the ITT population with available RQLQ practical problems score at Endpoint visit and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and at endpoint of the 2 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1 | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. | Number of participants from the ITT population with available RQLQ practical problems score at Visit 3 (Week 1) and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2 | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. | Number of participants from the ITT population with available RQLQ practical problems score at Visit 4 (Week 2) and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Endpoint During the Two-week Treatment Period | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. | Number of participants from the ITT population with available RQLQ nasal symptoms score at Endpoint visit and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and at endpoint of the 2 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1 | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. | Number of participants from the ITT population with available RQLQ nasal symptoms score at Visit 3 (Week 1) and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2 | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. | Number of participants from the ITT population with available RQLQ nasal symptoms score at Visit 4 (Week 2) and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Endpoint During the Two-week Treatment Period | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. | Number of participants from the ITT population with available RQLQ eye symptoms score at Endpoint visit and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and at endpoint of the 2 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1 | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. | Number of participants from the ITT population with available RQLQ eye symptoms score at Visit 3 (Week 1) and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2 | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. | Number of participants from the ITT population with available RQLQ eye symptoms score at Visit 4 (Week 2) and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Endpoint During the Two-week Treatment Period | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. | Number of participants from the ITT population with available RQLQ emotional score at Endpoint visit and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and at endpoint of the 2 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1 | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. | Number of participants from the ITT population with available RQLQ emotional score at Visit 3 (Week 1) and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2 | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. | Number of participants from the ITT population with available RQLQ emotional score at Visit 4 (Week 2) and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Total 5 Symptoms Score (T5SS) Over the First Week | Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T5SS ranges from 0 to 15. An average over the first week is provided. | Number of participants from the ITT population with available T5SS over Week 1 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Total 5 Symptoms Score (T5SS) Over the Second Week | Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T5SS ranges from 0 to 15. An average over the second week of treatment is provided. | Number of participants from the ITT population with available T5SS over Week 2 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Total 4 Symptoms Score (T4SS) Over the First Week | Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the first week of treatment is provided. | Number of participants from the ITT population with available T4SS over Week 1 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Total 4 Symptoms Score (T4SS) Over the Second Week | Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the second week of treatment is provided. | Number of participants from the ITT population with available T4SS over Week 2 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days) | Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the total treatment period of 14 days is provided. | Number of participants from the ITT population with available T4SS over the Total Treatment period | Posted | | Mean | Standard Deviation | points on a scale | | Over total treatment period (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Total Nasal Symptom Score (TNSS) Over the First Week | Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the first week of treatment is provided. | Number of participants from the ITT population with available TNSS over Week 1 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Total Nasal Symptom Score (TNSS) Over the Second Week | Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the second week of treatment is provided. | Number of participants from the ITT population with available TNSS over Week 2 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days) | Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the total treatment period is provided. | Number of participants from the ITT population with available TNSS over the Total Treatment period | Posted | | Mean | Standard Deviation | points on a scale | | Over total treatment period (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Total Ocular Symptom Score (TOSS) Over the First Week | Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the first week of treatment is provided. | Number of participants from the ITT population with available TOSS over Week 1 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Total Ocular Symptom Score (TOSS) Over the Second Week | Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the second week of treatment is provided. | Number of participants from the ITT population with available TOSS over Week 2 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days) | Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the total treatment period is provided. | Number of participants from the ITT population with available TOSS over the Total Treatment period | Posted | | Mean | Standard Deviation | points on a scale | | Over total treatment period (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Sneezing Score Over the First Week | The sneezing score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. | Number of participants from the ITT population with available sneezing score over Week 1 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Sneezing Score Over the Second Week | The sneezing score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. | Number of participants from the ITT population with available sneezing score over Week 2 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Sneezing Score Over the Total Treatment Period (14 Days) | The sneezing score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. | Number of participants from the ITT population with available sneezing score over the Total Treatment period | Posted | | Mean | Standard Deviation | points on a scale | | Over total treatment period (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Rhinorrhea Score Over the First Week | The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. | Number of participants from the ITT population with available rhinorrhea score over Week 1 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Rhinorrhea Score Over the Second Week | The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. | Number of participants from the ITT population with available rhinorrhea score over Week 2 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Rhinorrhea Score Over the Total Treatment Period (14 Days) | The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. | Number of participants from the ITT population with available rhinorrhea score over the Total Treatment period | Posted | | Mean | Standard Deviation | points on a scale | | Over total treatment period (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Nasal Congestion Score Over the First Week | The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. | Number of participants from the ITT population with available nasal congestion score over Week 1 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Nasal Congestion Score Over the Second Week | The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. | Number of participants from the ITT population with available nasal congestion score over Week 2 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Nasal Congestion Score Over the Total Treatment Period (14 Days) | The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. | Number of participants from the ITT population with available nasal congestion score over the Total Treatment period | Posted | | Mean | Standard Deviation | points on a scale | | Over total treatment period (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Nasal Pruritus Score Over the First Week | The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. | Number of participants from the ITT population with available nasal pruritus score over Week 1 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Nasal Pruritus Score Over the Second Week | The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. | Number of participants from the ITT population with available nasal pruritus score over Week 2 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Nasal Pruritus Score Over the Total Treatment Period (14 Days) | The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. | Number of participants from the ITT population with available nasal pruritus score over the Total Treatment period | Posted | | Mean | Standard Deviation | points on a scale | | Over total treatment period (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Post-nasal Drip Score Over the First Week | The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. | Number of participants from the ITT population with available post-nasal drip score over Week 1 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Post-nasal Drip Score Over the Second Week | The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. | Number of participants from the ITT population with available post-nasal drip score over Week 2 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Post-nasal Drip Score Over the Total Treatment Period (14 Days) | The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. | Number of participants from the ITT population with available post-nasal drip score over the Total Treatment period | Posted | | Mean | Standard Deviation | points on a scale | | Over total treatment period (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Ocular Pruritus Score Over the First Week | The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. | Number of participants from the ITT population with available ocular pruritus score over Week 1 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Ocular Pruritus Score Over the Second Week | The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. | Number of participants from the ITT population with available ocular pruritus score over Week 2 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Ocular Pruritus Score Over the Total Treatment Period (14 Days) | The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. | Number of participants from the ITT population with available ocular pruritus score over the Total Treatment period | Posted | | Mean | Standard Deviation | points on a scale | | Over total treatment period (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Ocular Itching/Burning Score Over the First Week | The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. | Number of participants from the ITT population with available ocular itching/burning score over Week 1 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Ocular Itching/Burning Score Over the Second Week | The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. | Number of participants from the ITT population with available ocular itching/burning score over Week 2 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Ocular Itching/Burning Score Over the Total Treatment Period (14 Days) | The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. | Number of participants from the ITT population with available ocular itching/burning score over the Total Treatment period | Posted | | Mean | Standard Deviation | points on a scale | | Over total treatment period (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Ocular Tearing/Watering Score Over the First Week | The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. | Number of participants from the ITT population with available ocular tearing/watering score over Week 1 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Ocular Tearing/Watering Score Over the Second Week | The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. | Number of participants from the ITT population with available ocular tearing/watering score over Week 2 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days) | The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. | Number of participants from the ITT population with available ocular tearing/watering score over the Total Treatment period | Posted | | Mean | Standard Deviation | points on a scale | | Over total treatment period (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Ocular Redness Score Over the First Week | The ocular redness score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. | Number of participants from the ITT population with available ocular redness score over Week 1 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Ocular Redness Score Over the Second Week | The ocular redness score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. | Number of participants from the ITT population with available ocular redness score over Week 2 | Posted | | Mean | Standard Deviation | points on a scale | | Over week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Ocular Redness Score Over the Total Treatment Period (14 Days) | The ocular redness score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. | Number of participants from the ITT population with available ocular redness score over the Total Treatment period | Posted | | Mean | Standard Deviation | points on a scale | | Over total treatment period (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period | Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Patient had to tick a box going from "Marked worsening" to "Marked improvement". | Number of participants from the ITT population | Posted | | Number | | participants | | Baseline and at endpoint of the 2 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period | Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Physician had to tick a box going from "Marked worsening" to "Marked improvement". | Number of participants from the ITT population | Posted | | Number | | participants | | Baseline and at endpoint of the 2 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. | Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Endpoint visit and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and at endpoint of the 2 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 1 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. | Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Week 1 and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 2 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. | Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Week 2 and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Endpoint During the Two-week Treatment Period | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. | Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Endpoint visit and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and at endpoint of the 2 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 1 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. | Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Week 1 and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 2 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. | Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Week 2 and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Endpoint During the Two-week Treatment Period | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. | Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Endpoint visit and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and at endpoint of the 2 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 1 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. | Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Week 1 and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 2 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. | Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Week 2 and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. | Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Endpoint visit and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and at endpoint of the 2 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 1 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. | Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Week 1 and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 2 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. | Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Week 2 and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Endpoint During the Two-week Treatment Period | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. | Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Endpoint visit and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and at endpoint of the 2 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 1 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. | Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Week 1 and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 2 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. | Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Week 2 and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Endpoint During the Two-week Treatment Period | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. | Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Endpoint visit and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and at endpoint of the 2 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 1 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. | Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Week 1 and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
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| Secondary | Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 2 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. | Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Week 2 and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
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| Secondary | Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Endpoint During the Two-week Treatment Period | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. | Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Endpoint visit and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and at endpoint of the 2 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 1 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. | Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Week 1 and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 2 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. | Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Week 2 and at Baseline | Posted | | Mean | Standard Deviation | percent change | | Baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Endpoint During the Two-week Treatment Period | The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. | Number of participants from the ITT population with available ESS score at Endpoint visit and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and at endpoint of the 2 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1 | The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness. | Number of participants from the ITT population with available ESS score at Week 1 and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2 | The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness. | Number of participants from the ITT population with available ESS score at Week 2 and at Baseline | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |
| Secondary | Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period | The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. | Number of participants from the ITT population | Posted | | Number | | participants | | Baseline and at endpoint of the 2 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching oral placebo tablet daily for 14 days | | OG001 | Levocetirizine | Levocetirizine (LCTZ) 5 mg tablet daily for 14 days |
| |