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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-003858-26 | EudraCT Number |
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Comparison of clinical efficacy and safety of levocetirizine in PER continuous versus on demand, measured by evolution of individual symptom scores during 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Treatment | Experimental | 5 mg of Levocetirizine (LCTZ) was taken orally once a day. |
|
| On Demand Treatment | Experimental | 5 mg of Levocetirizine (LCTZ) was taken whenever needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levocetirizine | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period | The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. | During the treatment period until week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period | The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genova | Italy |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Participant Flow refers to the Randomized Set.
The study started to enroll patients in March 2005 and concluded in June 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Treatment (CT) | 5 mg of Levocetirizine (LCTZ) was taken orally once a day. |
| FG001 | On Demand Treatment (ODT) | 5 mg of Levocetirizine (LCTZ) was taken whenever needed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline Characteristics refer to the Intention-to-Treat Population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Treatment (CT) | 5 mg of Levocetirizine (LCTZ) was taken orally once a day. |
| BG001 | On Demand Treatment (ODT) | 5 mg of Levocetirizine (LCTZ) was taken whenever needed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period | The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. | Only patients with a valid mean weekly T4SS during the treatment period were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | During the treatment period until week 24 |
|
Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continuous Treatment (SS) | 5 mg of Levocetirizine (LCTZ) was taken orally once a day. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eustachian tube obstruction | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844 599 | 2273 | UCBCares@ucb.com |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D012912 | Sneezing |
| D000086722 | Rhinorrhea |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C472067 | levocetirizine |
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|
| During month 1 of the 6 months treatment period |
| Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period | The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. | During month 2 of the 6 months treatment period |
| Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period | The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. | During month 3 of the 6 months treatment period |
| Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period | The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. | During month 4 of the 6 months treatment period |
| Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period | The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. | During month 5 of the 6 months treatment period |
| Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period | The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. | During month 6 of the 6 months treatment period |
| Mean Weekly Individual Symptoms Scores During the Treatment Period | Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity. | During the treatment period until week 24 |
| Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period | Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity. | During month 1 of the 6 months treatment period |
| Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period | Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity. | During month 2 of the 6 months treatment period |
| Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period | Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity. | During month 3 of the 6 months treatment period |
| Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period | Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity. | During month 4 of the 6 months treatment period |
| Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period | Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity. | During month 5 of the 6 months treatment period |
| Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period | Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity. | During month 6 of the 6 months treatment period |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG002 | Total Title |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| On Demand Treatment (ODT) |
5 mg of Levocetirizine (LCTZ) was taken whenever needed. |
|
|
|
| Secondary | Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period | The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. | Only patients with a valid T4SS at month 1 were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | During month 1 of the 6 months treatment period |
|
|
|
| Secondary | Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period | The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. | Only patients with a valid T4SS at month 2 were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | During month 2 of the 6 months treatment period |
|
|
|
| Secondary | Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period | The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. | Only patients with a valid T4SS at month 3 were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | During month 3 of the 6 months treatment period |
|
|
|
| Secondary | Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period | The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. | Only patients with a valid T4SS at month 4 were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | During month 4 of the 6 months treatment period |
|
|
|
| Secondary | Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period | The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. | Only patients with a valid T4SS at month 5 were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | During month 5 of the 6 months treatment period |
|
|
|
| Secondary | Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period | The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. | Only patients with a valid T4SS at month 6 were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | During month 6 of the 6 months treatment period |
|
|
|
| Secondary | Mean Weekly Individual Symptoms Scores During the Treatment Period | Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity. | 31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean weekly individual symptoms scores were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score. | Posted | Least Squares Mean | Standard Error | units on a scale | During the treatment period until week 24 |
|
|
|
| Secondary | Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period | Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity. | 31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 1 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score. | Posted | Least Squares Mean | Standard Error | units on a scale | During month 1 of the 6 months treatment period |
|
|
|
| Secondary | Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period | Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity. | 31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 2 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score. | Posted | Least Squares Mean | Standard Error | units on a scale | During month 2 of the 6 months treatment period |
|
|
|
| Secondary | Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period | Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity. | 31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 3 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score. | Posted | Least Squares Mean | Standard Error | units on a scale | During month 3 of the 6 months treatment period |
|
|
|
| Secondary | Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period | Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity. | 31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 4 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score. | Posted | Least Squares Mean | Standard Error | units on a scale | During month 4 of the 6 months treatment period |
|
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| Secondary | Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period | Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity. | 31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 5 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score. | Posted | Least Squares Mean | Standard Error | units on a scale | During month 5 of the 6 months treatment period |
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| Secondary | Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period | Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity. | 31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 6 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score. | Posted | Least Squares Mean | Standard Error | units on a scale | During month 6 of the 6 months treatment period |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 4 |
| 30 |
| EG001 | On Demand Treatment (SS) | 5 mg of Levocetirizine (LCTZ) was taken whenever needed. | 0 | 32 | 0 | 32 | 10 | 32 |
| Vertigo | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Rhinorrhea Score |
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| Nasal Pruritus Score |
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| Ocular Pruritus Score |
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| Nasal Congestion Score |
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| Rhinorrhea Score |
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| Nasal Pruritus Score |
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| Ocular Pruritus Score |
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| Nasal Congestion Score |
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| Rhinorrhea Score |
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| Nasal Pruritus Score |
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| Ocular Pruritus Score |
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| Nasal Congestion Score |
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| Rhinorrhea Score |
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| Nasal Pruritus Score |
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| Ocular Pruritus Score |
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| Nasal Congestion Score |
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| Rhinorrhea Score |
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| Nasal Pruritus Score |
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| Ocular Pruritus Score |
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| Nasal Congestion Score |
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| Rhinorrhea Score |
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| Nasal Pruritus Score |
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| Ocular Pruritus Score |
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| Nasal Congestion Score |
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| Rhinorrhea Score |
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| Nasal Pruritus Score |
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| Ocular Pruritus Score |
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| Nasal Congestion Score |
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