| Primary | Mean Nasal Symptom Score | Nasal symptoms (sneezing, rhinorrhea and nasal congestion) were recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 4 (intense/severe). Nasal symptom score (0-12 point) consisted of score for severity of sneezing (0-4 point), rhinorrhea (0-4 point) and nasal congestion (0-4 point). Severe symptom period: The three weeks where the cumulative value of the mean daily nasal symptom score is the maximum. The three weeks must also meet one of the following criteria: 2) ≥ 70% of the period with concomitant use of fluticasone propionate is included in this three weeks. 2) ≥ 70% of this three weeks includes the period with concomitant use of fluticasone propionate. If not, severe symptom period was extended at a minimum to meet one of the criteria above. The severe symptom period will be defined as: the three weeks where the cumulative value of the mean daily nasal symptom score will be the maximum. | Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included. | Posted | | Least Squares Mean | Standard Error | score | | Severe symptom period (from 23Feb2018 to 24March2018) | | | | ID | Title | Description |
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| OG000 | Omalizumab | Omalizumab administered subcutaneously for 12 weeks | | OG001 | Placebo | Placebo administered subcutaneously for 12 weeks |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0003.66± 0.151
- OG0014.69± 0.144
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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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| | ANCOVA | | <0.001 | H0: Omalizumab is not different to placebo with respect to mean nasal symptom score over the severe symptom period. H1: Omalizumab is different to placebo with respect to mean nasal symptom score over the severe symptom period. | Least Square Mean | -1.03 | Standard Error of the Mean | 0.209 | 2-Sided | 95 | -1.44 | -0.62 | | | | | Other | | |
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| Secondary | Mean Ocular Symptom Score and Mean Nasal Ocular Symptom Score | Ocular symptoms (itchy and watery eye) were recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 4 (intense/severe). Ocular symptom score (0-8 point) consisted of score for severity of itchy eye (0-4 point) and watery eye (0-4 point). Nasal ocular symptom score consisted of nasal symptom score and ocular symptom score. Nasal ocular symptom score is the sum of nasal symptom score (0-12) and ocular symptom score (0-8) 0 presents no nasal ocular symptom and 20 presents worse outcome. | Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included. | Posted | | Least Squares Mean | Standard Error | Score | | Severe symptom period (from 23Feb2018 to 24Mar2018) | | | | ID | Title | Description |
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| OG000 | Omalizumab | Omalizumab administered subcutaneously for 12 weeks | | OG001 | Placebo | Placebo administered subcutaneously for 12 weeks |
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| Secondary | Mean Nasal Symptom Medication Score, Mean Ocular Symptom Medication Score, and Mean Nasal Ocular Symptom Medication Score | Medication scores were given for fluticasone propionate (nasal, 2 point), fexofenadine hydrochloride (oral, 1 point), tramazoline hydrochloride (nasal, 1 point), and levocabastine hydrochloride (ocular, 1 point). Symptom medication score consisted of severe symptom period. Nasal symptom medication score is the sum of nasal symptom score and medication score (fexofenadine hydrochloride, fluticasone propionate, tramazoline hydrochloride) Ocular symptom medication score is the sum of ocular symptom score and medication score (fexofenadine hydrochloride, levocabastine hydrochloride) Nasal ocular symptom medication score is the sum of nasal symptom score, ocular symptom score and medication score (fexofenadine hydrochloride, fluticasone propionate, tramazoline hydrochloride, levocabastine hydrochloride). | Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included. | Posted | | Least Squares Mean | Standard Error | score | | Severe symptom period (from 23Feb2018 to 24Mar2018) | | | | ID | Title | Description |
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| OG000 | Omalizumab | Omalizumab administered subcutaneously for 12 weeks | | OG001 | Placebo | Placebo administered subcutaneously for 12 weeks |
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| Secondary | Mean Score for Severity of Sneezing, Rhinorrhea and Nasal Congestion | Symptoms of sneezing, rhinorrhea and nasal congestion were evaluated on a scale of 0 (none) to 4 (intense/severe). | Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included. | Posted | | Least Squares Mean | Standard Error | score | | Severe symptom period (from 23Feb2018 to 24Mar2018) | | | | ID | Title | Description |
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| OG000 | Omalizumab | Omalizumab administered subcutaneously for 12 weeks | | OG001 | Placebo | Placebo administered subcutaneously for 12 weeks |
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| Secondary | Mean Score for Severity of Itchy and Watery Eye | Symptoms of itchy and watery eye were evaluated on a scale of 0 (none) to 4 (intense/severe). | Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included. | Posted | | Least Squares Mean | Standard Error | score | | Severe symptom period (from 23Feb2018 to 24Mar2018) | | | | ID | Title | Description |
|---|
| OG000 | Omalizumab | Omalizumab administered subcutaneously for 12 weeks | | OG001 | Placebo | Placebo administered subcutaneously for 12 weeks |
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| Secondary | Mean Score for Impairment of Daily Activities | Impairment of daily activities were evaluated on a scale of 0 (none) to 4 (intense/severe). | Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included. | Posted | | Least Squares Mean | Standard Error | score | | Severe symptom period (from 23Feb2018 to 24Mar2018) | | | | ID | Title | Description |
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| OG000 | Omalizumab | Omalizumab administered subcutaneously for 12 weeks | | OG001 | Placebo | Placebo administered subcutaneously for 12 weeks |
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| Secondary | Number of Symptom Free Days | Nasal symptom free days (days with all nasal symptoms are not more than mild in severity) during the severe symptom period. Ocular symptom free days (days with all ocular symptoms are not more than mild in severity) during the severe symptom period. | Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included. | Posted | | Median | Full Range | days | | Severe symptom period (from 23Feb2018 to 24March2018) | | | | ID | Title | Description |
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| OG000 | Omalizumab | Omalizumab administered subcutaneously for 12 weeks | | OG001 | Placebo | Placebo administered subcutaneously for 12 weeks |
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| Secondary | Completely Nasal Symptom Free Patients | Completely nasal symptom free patients is the number of patients who were nasal symptom free (all nasal symptoms were not more than mild in severity) on all non-missing days and had nasal symptom scores for at least 26 days during the 30 days of severe symptom period. | Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included. | Posted | | Count of Participants | | Participants | | Severe symptom period (from 23Feb2018 to 24Mar2018) | | | | ID | Title | Description |
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| OG000 | Omalizumab | Omalizumab administered subcutaneously for 12 weeks | | OG001 | Placebo | Placebo administered subcutaneously for 12 weeks |
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| Secondary | Rescue Medication Score | Rescue medication scores were given for tramazoline hydrochloride (nasal, 1 point) and levocabastine hydrochloride (ocular, 1 point). Rescue medication score for nasal is medication score for Tramazoline hydrochloride, Rescue medication score for ocular is medication score for Levocabastine hydrochloride and Rescue medication score for nasal and ocular is the sum of medication score for Tramazoline hydrochloride and Levocabastine hydrochlorid | Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included. | Posted | | Least Squares Mean | Standard Error | score | | Severe symptom period (from 23Feb2018 to 24Mar2018) | | | | ID | Title | Description |
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| OG000 | Omalizumab | Omalizumab administered subcutaneously for 12 weeks | | OG001 | Placebo | Placebo administered subcutaneously for 12 weeks |
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| Secondary | Rescue Medication Free Days | Number of days with no rescue medication (tramazoline hydrochloride, levocabastine hydrochloride). Nasal ocular rescue medication free days were defined as the days with no use of tramazoline hydrochloride (nasal rescue medication) and levocabastine hydrochloride (ocular rescue medication). | Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included. | Posted | | Median | Full Range | days | | Severe symptom period (from 23Feb2018 to 24Mar2018) | | | | ID | Title | Description |
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| OG000 | Omalizumab | Omalizumab administered subcutaneously for 12 weeks | | OG001 | Placebo | Placebo administered subcutaneously for 12 weeks |
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| Secondary | Number of Rescue Medication Used | Amount number of rescue medication used (a total number of times used). | Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included. | Posted | | Median | Full Range | Number of times used | | Severe symptom period (from 23Feb2018 to 24Mar2018) | | | | ID | Title | Description |
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| OG000 | Omalizumab | Omalizumab administered subcutaneously for 12 weeks | | OG001 | Placebo | Placebo administered subcutaneously for 12 weeks |
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| Secondary | Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ, No1) Score | Nasal and eye symptoms (JRQLQ I) included 6 categories: Runny nose, Sneezing, Nasal congestion, Itchy nose, itchy eyes and watery eyes, on a 5-point scale of 0 to 4 (no symptoms to very severe symptoms). JRQLQ I score was a mean of these 6 categories. JRQLQ II included 17 items on a 5-point scale, 0 to 4 (no significant problem to very greatly). JRQLQ II scores was a mean of these 17 items. Overall face scale (JRQLQ III) evaluated overall symptoms, condition and feelings on a 5-point scale from 0 to 4 (fine to crying). Evaluation visit was defined as follows independently for each evaluation item and for each patient: 1) If there was a single visit during the severe symptom period, the visit was the evaluation visit. 2) If there were ≥ 2 visits during the severe symptom period and a) if Visit 105 was one of them, Visit 105 was the evaluation visit; b) if Visit 105 was outside the period, the closest visit to Visit 105 during the period was the evaluation visit. | Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Score | | Evaluation Visit, one visit during severe symptom period (23-Feb-2018 to 24-Mar-2018) for each patient | | | | ID | Title | Description |
|---|
| OG000 | Omalizumab | Omalizumab administered subcutaneously for 12 weeks | | OG001 | Placebo | Placebo administered subcutaneously for 12 weeks |
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| Secondary | Number of Participants With Anti-omalizumab Antibodes | Number of participants with antibodies against the Fab and Fc region of omalizumab in serum. | Safety set (SAF): The SAF consisted of all patients who received at least 1 dose of study drug. Patients in the SAF were analyzed according to treatment actually received. | Posted | | Number | | participants | | Prior to first dosing (Day 1), At follow-up investigation which were conducted 20/22 weeks after 12 week-treatment epoch | | | | ID | Title | Description |
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| OG000 | Omalizumab | Omalizumab administered subcutaneously for 12 weeks | | OG001 | Placebo | Placebo administered subcutaneously for 12 weeks |
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| Secondary | Serum Trough Omalizumab Concentration | Blood samples were collected Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and follow-up investigation which were conducted 20/22 weeks after 12 week-treatment epoch | Pharmacokinetic set (PK set): The PK set consisted of all randomized patients who received at least 1 dose of study drug and had at least 1 evaluable PK measurement. Patients in the PK set were analyzed according to the treatment they actually received. | Posted | | Mean | Standard Deviation | μg/mL | | Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and 24 weeks after last dose | | | | ID | Title | Description |
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| OG000 | Omalizumab | Omalizumab administered subcutaneously for 12 weeks |
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| Secondary | Free IgE and Total IgE | Blood samples were collected Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and follow-up investigation were conducted 20/22 weeks after 12 week-treatment epoch | Pharmacokinetic set (PK set): The PK set consisted of all randomized patients who received at least 1 dose of study drug and had at least 1 evaluable PK measurement. Patients in the PK set were analyzed according to the treatment they actually received. | Posted | | Mean | Standard Deviation | ng/mL | | Day 1, at Day 29, Day 57, Day 85 and 24 weeks after last dose | | | | ID | Title | Description |
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| OG000 | Omalizumab | Omalizumab administered subcutaneously for 12 weeks | | OG001 | Placebo | Placebo administered subcutaneously for 12 weeks |
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