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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000952-36 | EudraCT Number |
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A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare Efficacy and Safety of CT-P39 and Xolair in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic despite H1 antihistamine Treatment
CT-P39, containing the active ingredient omalizumab, is a recombinant humanized monoclonal antibody that is being developed and manufactured as a proposed biosimilar to Xolair (omalizumab) by the Sponsor. CT-P39 is identical to Xolair with respect to concentration and presentation. The 150 mg of drug product (CT-P39) will have the same pharmaceutical form and strength as 150 mg Xolair (in a prefilled syringe [PFS] for subcutaneous injection) and is intended to have a similar quality profile compared with Xolair.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Planned to receive CT-P39 300 mg every 4 weeks in Treatment Period 1 (TP1) and maintain CT-P39 300 mg in TP2 |
|
| Arm 2 | Active Comparator | Planned to receive Xolair 300 mg every 4 weeks in TP1 and be re-randomized at Week 12 to Arm 2-1 or Arm 2-2 |
|
| Arm 2-1 | Active Comparator | Planned to receive Xolair 300 mg every 4 weeks in TP1 and be re-randomized to switch to CT-P39 300 mg in TP2 |
|
| Arm 2-2 | Active Comparator | Planned to receive Xolair 300 mg every 4 weeks in TP1 and be re-randomized to maintain Xolair 300 mg in TP2 |
|
| Arm 3 | Experimental | Planned to receive CT-P39 150 mg every 4 weeks in Treatment Period 1 (TP1) and increase to CT-P39 300 mg in TP2 |
|
| Arm 4 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P39 | Biological | Prefilled syringe (PFS) of 1 mL solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic Equivalence Based on Change From Baseline in ISS7 at Week 12 in 300 mg Groups | The primary efficacy evaluation was comparison of mean change from baseline in ISS7 of 300 mg of CT-P39 (Arm 1) and 300 mg of Xolair (Arm 2) at Week 12, calculated as ISS7 at Week 12 minus the baseline ISS7. The ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome. The analysis was conducted by analysis of covariance (ANCOVA). The ANCOVA model included the treatment group as a fixed effect and baseline ISS7, body weight on Day 1 and country as covariates. | Week 12 |
| Relative Potency of CT-P39 Compared With Xolair Based on Change From Baseline in ISS7 at Week 12 | The ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome. The relative potency was not calculated due to the assumption of parallel-line assay not being met. A parallel-line assay assumes that dose-efficacy response relationships are linear and parallel on log-dose scale which requires the equal slope in the regression model used to estimate relative potency. However, the slopes of the two treatment groups were estimated to be different, indicating a violation of the parallelism assumption. As a result, the relative potency was not computed. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 | The change from baseline in ISS7 at Week 12 was calculated as ISS7 at Week 12 minus the baseline ISS7. The ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome. The relative potency based on the CFB of ISS7 at Week 12 was not calculated due to assumption of parallel-line assay not being met. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MinJi Ma | Celltrion, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinika Ambroziak ESTEDERM | Warsaw | Poland |
A total of 783 patients were screened for the study. Of these, 149 patients were excluded from the study due to screening failure and 634 patients were enrolled in the study. Of these 634 patients, 15 patients from the significantly GCP noncompliant study center were excluded from all analysis population. Finally, total of 619 patients were included in the data analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | Received CT-P39 300 mg every 4 weeks in Treatment Period 1 (TP1) and maintained CT-P39 300 mg in TP2 CT-P39: Prefilled syringe (PFS) of 1 mL solution |
| FG001 | Arm 2 | Received Xolair 300 mg every 4 weeks in TP1 and re-randomized at Week 12 to Arm 2-1 or Arm 2-2 EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution |
| FG002 | Arm 2-1 | Received Xolair 300 mg every 4 weeks in TP1 and re-randomized to switch to CT-P39 300 mg in TP2 EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution CT-P39: Prefilled syringe (PFS) of 1 mL solution |
| FG003 | Arm 2-2 | Received Xolair 300 mg every 4 weeks in TP1 and maintained Xolair 300 mg in TP2 EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution |
| FG004 | Arm 3 | Received CT-P39 150 mg every 4 weeks in Treatment Period 1 (TP1) and increased to CT-P39 300 mg in TP2 CT-P39: Prefilled syringe (PFS) of 1 mL solution |
| FG005 | Arm 4 | Received Xolair 150 mg every 4 weeks in Treatment Period 1 (TP1) and increased to Xolair 300 mg in TP2 EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (Week 0 to Week 12) |
| |||||||||||||
| Treatment Period 2 (Week 12 to Week 24) |
| |||||||||||||
| Follow Up Period |
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The RAN Set was defined as all randomly assigned patients prior to dosing on Day 1 regardless of whether they received any study drug (CT-P39 or Xolair).
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period (TP1) CT-P39: Prefilled syringe (PFS) of 1 mL solution |
| BG001 | Arm 2 | Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1 EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Therapeutic Equivalence Based on Change From Baseline in ISS7 at Week 12 in 300 mg Groups | The primary efficacy evaluation was comparison of mean change from baseline in ISS7 of 300 mg of CT-P39 (Arm 1) and 300 mg of Xolair (Arm 2) at Week 12, calculated as ISS7 at Week 12 minus the baseline ISS7. The ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome. The analysis was conducted by analysis of covariance (ANCOVA). The ANCOVA model included the treatment group as a fixed effect and baseline ISS7, body weight on Day 1 and country as covariates. | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | Posted | Least Squares Mean | Standard Error | score on a scale | Week 12 |
Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set.
The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs.
The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
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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 | Arm 1/Treatment Period 1 | Received 300 mg of CT-P39 as SC injections via PFS in Treatment Period 1 (TP1) CT-P39: Prefilled syringe (PFS) of 1 mL solution |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial ischaemia | Cardiac disorders | Meddra 25.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | Meddra 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yunju Bae/Head of Clinical Planning 1 Department | Celltrion. Inc | +82 32 850 4160 | Yunju.bae@celltrion.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 10, 2021 | Apr 28, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 3, 2023 | Apr 28, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Active Comparator |
Planned to receive Xolair 150 mg every 4 weeks in Treatment Period 1 (TP1) and increase to Xolair 300 mg in TP2 |
|
| EU-approved Xolair | Biological | Prefilled syringe (PFS) of 1 mL solution |
|
|
| Week 12 |
| Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 24 | The change from baseline in ISS7 at Week 24 was calculated as ISS7 at Week 24 minus the baseline ISS7. The ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome. | Week 24 |
| Time to Minimally Important Difference (MID) in ISS7 by Week 12 | Time to MID response was the time (in weeks) from Day 1 to the study week when reduction of 5 points or more from baseline for ISS7 was first achieved up to Week 12. If a patient failed to achieve an MID response up to Week 12 or terminated the study prior to Week 12 without achieving MID response, the patient was censored at the date (in weeks) of the last non-missing ISS7 evaluation. Time to MID was estimated by Kaplan-Meier method. The lower result means a better outcome. | Up to Week 12 |
| Percentage of Minimally Important Difference (MID) Responders in ISS7 at Week 12 | Number of patients who achieved MID response at Week 12 were presented. MID response is a change from baseline in ISS7 of ≤ -5. If a patient had missing weekly scores for the given week the patient was classified as a non-responder. The higher percentage means a better outcome. | Week 12 |
| Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12 | The change from baseline in HSS7 at Week 12 was calculated as HSS7 at Week 12 minus the baseline HSS7. The HSS was counted twice daily (morning and evening) in the patient eDiary, on a scale of 0 (none) to 3 (intense) points. The daily HSS is the average of the morning and evening scores, and the HSS7 is the sum of the daily HSS over 7 days. HSS7 can range from 0 to 21. The higher scores mean a worse outcome. | Week 12 |
| Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 24 | The change from baseline in HSS7 at Week 24 was calculated as HSS7 at Week 24 minus the baseline HSS7. The HSS was counted twice daily (morning and evening) in the patient eDiary, on a scale of 0 (none) to 3 (intense) points. The daily HSS is the average of the morning and evening scores, and the HSS7 is the sum of the daily HSS over 7 days. HSS7 can range from 0 to 21. The higher scores mean a worse outcome. | Week 24 |
| Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12 | The change from baseline in UAS7 at Week 12 was calculated as UAS7 at Week 12 minus the baseline UAS7. The UAS was calculated as the sum of the ISS and the HSS by diary-based documentation. The sum of the scores represented disease severity on a scale from 0 (minimum) to 6 (maximum). The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS over 7 days. UAS7 can range from 0 to 42. The higher scores mean a worse outcome. | Week 12 |
| Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 24 | The change from baseline in UAS7 at Week 24 was calculated as UAS7 at Week 24 minus the baseline UAS7. The UAS was calculated as the sum of the ISS and the HSS by diary-based documentation. The sum of the scores represented disease severity on a scale from 0 (minimum) to 6 (maximum). The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS over 7 days. UAS7 can range from 0 to 42. The higher scores mean a worse outcome. | Week 24 |
| Percentage of Patients With UAS7 of ≤ 6 Points and Complete Responders in Weekly Urticaria Activity Score at Week 12 | Percentage of patients with Weekly Urticaria Activity Score (UAS7) of ≤ 6 points and complete responders (UAS7 = 0) at Week 12 is presented. If a patient had missing weekly scores for the given week the patient was classified as a non-responder. UAS7 can range from 0 to 42. The higher result means a better outcome. | Week 12 |
| Percentage of Patients With UAS7 of ≤ 6 Points and Complete Responders in Weekly Urticaria Activity Score at Week 24 | The number of patients with Weekly Urticaria Activity Score (UAS7) of ≤ 6 points and complete responders (UAS7 = 0) at Week 24 is presented. If a patient had missing weekly scores for the given week the patient was classified as a non-responder. UAS7 can range from 0 to 42. The higher result means a better outcome. | Week 24 |
| Percentage of Angioedema-Free Days From Week 4 to Week 12 | The proportion of angioedema-free days from Week 4 to Week 12 is defined as the number of days for which the patient indicated a 'No' response to the angioedema question in the patient eDiary divided by the total number of days with a non-missing diary entry starting on Week 4 visit date and ending the day prior to Week 12 visit date. Patients who had missing responses for > 40% of the daily diary entries between Week 4 visit date and Week 12 visit date were not included in this analysis. The higher result means a better outcome. | Week 4 to 12 |
| Change From Baseline in Number of Tablets/Week of Rescue Therapy at Week 12 | The change from baseline in the number of tablets/week of rescue therapy used at Week 12 is presented. The number of tablets for each week of rescue therapy will be defined as the sum of daily use of rescue therapy over the study days which make up a given study week. The higher value means a worse outcome. If a subject switched rescue therapy medication and started a different medication or the prescribed dose of the rescue therapy medication changed during the study, the subject was excluded from the summary. | Week 12 |
| Change From Baseline in Number of Tablets/Week of Rescue Therapy at Week 24 | The change from baseline in the number of tablets/week of rescue therapy used at Week 24 is presented. The number of tablets for each week of rescue therapy will be defined as the sum of daily use of rescue therapy over the study days which make up a given study week. The higher value means a worse outcome. If a subject switched rescue therapy medication and started a different medication or the prescribed dose of the rescue therapy medication changed during the study, the subject was excluded from the summary. | Week 24 |
| Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12 | The change from baseline in mean overall DLQI score at Week 12 is presented. The DLQI is a 10-item dermatology-specific health-related questionnaire across 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspect of their lives. Each question is scored from 0 to 3. Overall DLQI ranges on a scale of 0 to 30. The higher result means a worse outcome. | Week 12 |
| Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 24 | The change from baseline in mean overall DLQI score at Week 24 is presented. The DLQI is a 10-item dermatology-specific health-related questionnaire across 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspect of their lives. Each question is scored from 0 to 3. Overall DLQI ranges on a scale of 0 to 30. The higher result means a worse outcome. | Week 24 |
| Change From Baseline in the Overall Chronic Urticaria Quality of Life Questionnaire Score (CU-Q2oL) Score at Week 12 | The change from baseline in mean overall CU-Q2oL score at Week 12 is presented. The CU-Q2oL is a 23-item CSU specific health-related QoL questionnaire across 6 domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. Patients rated their CSU symptoms and the impact of their CSU on various aspects of their lives. Each question was scored from 1 (not at all) to 5 (extremely), and overall raw score, on a scale of 23 to 115, was calculated by summing the individual raw domain scores. The higher result means a worse outcome. Overall raw scores of CU-Q2oL were converted to 0 to 100 point scores according to the following formula:[(sum of items - minimum) / (maximum - minimum)] × 100, where minimum=23 (1 score for all 23 items), maximum=115 (5 score for all 23 items). | Week 12 |
| Change From Baseline in the Overall Chronic Urticaria Quality of Life Questionnaire Score (CU-Q2oL) Score at Week 24 | The change from baseline in mean overall CU-Q2oL score at Week 24 is presented. The CU-Q2oL is a 23-item CSU specific health-related QoL questionnaire across 6 domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. Patients rated their CSU symptoms and the impact of their CSU on various aspects of their lives. Each question was scored from 1 (not at all) to 5 (extremely), and overall raw score, on a scale of 23 to 115, was calculated by summing the individual raw domain scores. The higher result means a worse outcome. Overall raw scores of CU-Q2oL were converted to 0 to 100 point scores according to the following formula: [(sum of items - minimum) / (maximum - minimum)] × 100, where minimum=23 (1 score for all 23 items), maximum=115 (5 score for all 23 items) | Week 24 |
| Trough Serum Concentration (Ctrough) of Omalizumab at Week 12 | All concentration below lower limit of quantification (BLQ) values were treated as zero (0) for PK parameter summary. Below lower limit of quantification (BLQ) is treated as zero (0). | Week 12 |
| Trough Serum Concentration (Ctrough) of Omalizumab at Week 24 | All concentration below lower limit of quantification (BLQ) values were treated as zero (0) for PK parameter summary. Below lower limit of quantification (BLQ) is treated as zero (0). | Week 24 |
| Immunogenicity Result at Week 12 | Anti-drug Antibody test involved both screening and confirmatory assays to confirm true positive results. Samples that are positive in the screening assay underwent further testing in the confirmatory assay to determine if patients are true positive. Samples that are positive in the ADA confirmatory assay were analyzed further to conduct a NAb assessment. | Week 12 |
| Immunogenicity Result at Week 24 | Anti-drug Antibody test involved both screening and confirmatory assays to confirm true positive results. Samples that are positive in the screening assay underwent further testing in the confirmatory assay to determine if patients are true positive. Samples that are positive in the ADA confirmatory assay were analyzed further to conduct a NAb assessment. | Week 24 |
| COMPLETED | Refers Study drug completion |
|
| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
|
| BG002 | Arm 3 | Received 150 mg of CT-P39 as SC injections via PFS during TP1 CT-P39: Prefilled syringe (PFS) of 1 mL solution |
| BG003 | Arm 4 | Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1 EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Baseline ISS7 | The ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The baseline ISS7 is the sum of the daily ISS over the 7 days (Day -7 to -1) prior to the first study drug administration. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome. | Count of Participants | Participants |
|
| Weight on Day 1, | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Arm 1 | Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1) CT-P39: Prefilled syringe (PFS) of 1 mL solution |
| OG001 | Arm 2 | Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1 EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution |
|
|
|
| Primary | Relative Potency of CT-P39 Compared With Xolair Based on Change From Baseline in ISS7 at Week 12 | The ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome. The relative potency was not calculated due to the assumption of parallel-line assay not being met. A parallel-line assay assumes that dose-efficacy response relationships are linear and parallel on log-dose scale which requires the equal slope in the regression model used to estimate relative potency. However, the slopes of the two treatment groups were estimated to be different, indicating a violation of the parallelism assumption. As a result, the relative potency was not computed. | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | Posted | Number | 90% Confidence Interval | participants | Week 12 |
|
|
|
| Secondary | Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 | The change from baseline in ISS7 at Week 12 was calculated as ISS7 at Week 12 minus the baseline ISS7. The ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome. The relative potency based on the CFB of ISS7 at Week 12 was not calculated due to assumption of parallel-line assay not being met. | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 24 | The change from baseline in ISS7 at Week 24 was calculated as ISS7 at Week 24 minus the baseline ISS7. The ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome. | Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
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| Secondary | Time to Minimally Important Difference (MID) in ISS7 by Week 12 | Time to MID response was the time (in weeks) from Day 1 to the study week when reduction of 5 points or more from baseline for ISS7 was first achieved up to Week 12. If a patient failed to achieve an MID response up to Week 12 or terminated the study prior to Week 12 without achieving MID response, the patient was censored at the date (in weeks) of the last non-missing ISS7 evaluation. Time to MID was estimated by Kaplan-Meier method. The lower result means a better outcome. | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | Posted | Median | 95% Confidence Interval | in Weeks | Up to Week 12 |
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| Secondary | Percentage of Minimally Important Difference (MID) Responders in ISS7 at Week 12 | Number of patients who achieved MID response at Week 12 were presented. MID response is a change from baseline in ISS7 of ≤ -5. If a patient had missing weekly scores for the given week the patient was classified as a non-responder. The higher percentage means a better outcome. | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12 | The change from baseline in HSS7 at Week 12 was calculated as HSS7 at Week 12 minus the baseline HSS7. The HSS was counted twice daily (morning and evening) in the patient eDiary, on a scale of 0 (none) to 3 (intense) points. The daily HSS is the average of the morning and evening scores, and the HSS7 is the sum of the daily HSS over 7 days. HSS7 can range from 0 to 21. The higher scores mean a worse outcome. | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 24 | The change from baseline in HSS7 at Week 24 was calculated as HSS7 at Week 24 minus the baseline HSS7. The HSS was counted twice daily (morning and evening) in the patient eDiary, on a scale of 0 (none) to 3 (intense) points. The daily HSS is the average of the morning and evening scores, and the HSS7 is the sum of the daily HSS over 7 days. HSS7 can range from 0 to 21. The higher scores mean a worse outcome. | Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
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| Secondary | Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12 | The change from baseline in UAS7 at Week 12 was calculated as UAS7 at Week 12 minus the baseline UAS7. The UAS was calculated as the sum of the ISS and the HSS by diary-based documentation. The sum of the scores represented disease severity on a scale from 0 (minimum) to 6 (maximum). The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS over 7 days. UAS7 can range from 0 to 42. The higher scores mean a worse outcome. | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 24 | The change from baseline in UAS7 at Week 24 was calculated as UAS7 at Week 24 minus the baseline UAS7. The UAS was calculated as the sum of the ISS and the HSS by diary-based documentation. The sum of the scores represented disease severity on a scale from 0 (minimum) to 6 (maximum). The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS over 7 days. UAS7 can range from 0 to 42. The higher scores mean a worse outcome. | Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
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| Secondary | Percentage of Patients With UAS7 of ≤ 6 Points and Complete Responders in Weekly Urticaria Activity Score at Week 12 | Percentage of patients with Weekly Urticaria Activity Score (UAS7) of ≤ 6 points and complete responders (UAS7 = 0) at Week 12 is presented. If a patient had missing weekly scores for the given week the patient was classified as a non-responder. UAS7 can range from 0 to 42. The higher result means a better outcome. | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Percentage of Patients With UAS7 of ≤ 6 Points and Complete Responders in Weekly Urticaria Activity Score at Week 24 | The number of patients with Weekly Urticaria Activity Score (UAS7) of ≤ 6 points and complete responders (UAS7 = 0) at Week 24 is presented. If a patient had missing weekly scores for the given week the patient was classified as a non-responder. UAS7 can range from 0 to 42. The higher result means a better outcome. | Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table. The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II. | Posted | Count of Participants | Participants | Week 24 |
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| Secondary | Percentage of Angioedema-Free Days From Week 4 to Week 12 | The proportion of angioedema-free days from Week 4 to Week 12 is defined as the number of days for which the patient indicated a 'No' response to the angioedema question in the patient eDiary divided by the total number of days with a non-missing diary entry starting on Week 4 visit date and ending the day prior to Week 12 visit date. Patients who had missing responses for > 40% of the daily diary entries between Week 4 visit date and Week 12 visit date were not included in this analysis. The higher result means a better outcome. | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | Posted | Mean | Standard Deviation | percentage of Angioedema-Free Days | Week 4 to 12 |
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| Secondary | Change From Baseline in Number of Tablets/Week of Rescue Therapy at Week 12 | The change from baseline in the number of tablets/week of rescue therapy used at Week 12 is presented. The number of tablets for each week of rescue therapy will be defined as the sum of daily use of rescue therapy over the study days which make up a given study week. The higher value means a worse outcome. If a subject switched rescue therapy medication and started a different medication or the prescribed dose of the rescue therapy medication changed during the study, the subject was excluded from the summary. | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | Posted | Mean | Standard Deviation | Number of Tablets/Week | Week 12 |
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| Secondary | Change From Baseline in Number of Tablets/Week of Rescue Therapy at Week 24 | The change from baseline in the number of tablets/week of rescue therapy used at Week 24 is presented. The number of tablets for each week of rescue therapy will be defined as the sum of daily use of rescue therapy over the study days which make up a given study week. The higher value means a worse outcome. If a subject switched rescue therapy medication and started a different medication or the prescribed dose of the rescue therapy medication changed during the study, the subject was excluded from the summary. | Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II. | Posted | Mean | Standard Deviation | Number of Tablets/Week | Week 24 |
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| Secondary | Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12 | The change from baseline in mean overall DLQI score at Week 12 is presented. The DLQI is a 10-item dermatology-specific health-related questionnaire across 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspect of their lives. Each question is scored from 0 to 3. Overall DLQI ranges on a scale of 0 to 30. The higher result means a worse outcome. | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 24 | The change from baseline in mean overall DLQI score at Week 24 is presented. The DLQI is a 10-item dermatology-specific health-related questionnaire across 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspect of their lives. Each question is scored from 0 to 3. Overall DLQI ranges on a scale of 0 to 30. The higher result means a worse outcome. | Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
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| Secondary | Change From Baseline in the Overall Chronic Urticaria Quality of Life Questionnaire Score (CU-Q2oL) Score at Week 12 | The change from baseline in mean overall CU-Q2oL score at Week 12 is presented. The CU-Q2oL is a 23-item CSU specific health-related QoL questionnaire across 6 domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. Patients rated their CSU symptoms and the impact of their CSU on various aspects of their lives. Each question was scored from 1 (not at all) to 5 (extremely), and overall raw score, on a scale of 23 to 115, was calculated by summing the individual raw domain scores. The higher result means a worse outcome. Overall raw scores of CU-Q2oL were converted to 0 to 100 point scores according to the following formula:[(sum of items - minimum) / (maximum - minimum)] × 100, where minimum=23 (1 score for all 23 items), maximum=115 (5 score for all 23 items). | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Change From Baseline in the Overall Chronic Urticaria Quality of Life Questionnaire Score (CU-Q2oL) Score at Week 24 | The change from baseline in mean overall CU-Q2oL score at Week 24 is presented. The CU-Q2oL is a 23-item CSU specific health-related QoL questionnaire across 6 domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. Patients rated their CSU symptoms and the impact of their CSU on various aspects of their lives. Each question was scored from 1 (not at all) to 5 (extremely), and overall raw score, on a scale of 23 to 115, was calculated by summing the individual raw domain scores. The higher result means a worse outcome. Overall raw scores of CU-Q2oL were converted to 0 to 100 point scores according to the following formula: [(sum of items - minimum) / (maximum - minimum)] × 100, where minimum=23 (1 score for all 23 items), maximum=115 (5 score for all 23 items) | Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
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| Secondary | Trough Serum Concentration (Ctrough) of Omalizumab at Week 12 | All concentration below lower limit of quantification (BLQ) values were treated as zero (0) for PK parameter summary. Below lower limit of quantification (BLQ) is treated as zero (0). | Analysis was performed based on PK Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The PK Set was defined as all patients who received at least 1 full dose of either of the study drugs during Treatment Period I and had at least 1 post-treatment PK result prior to dosing at Week 12. | Posted | Mean | Standard Deviation | ug/mL | Week 12 |
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| Secondary | Trough Serum Concentration (Ctrough) of Omalizumab at Week 24 | All concentration below lower limit of quantification (BLQ) values were treated as zero (0) for PK parameter summary. Below lower limit of quantification (BLQ) is treated as zero (0). | Analysis was performed based on PK-TP2 Subset which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The PK-TP2 Subset was defined as all patients in PK Set who received at least 1 full dose of either of the study drugs during Treatment Period II and had at least 1 post-treatment PK result after Week 12 | Posted | Mean | Standard Deviation | ug/mL | Week 24 |
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| Secondary | Immunogenicity Result at Week 12 | Anti-drug Antibody test involved both screening and confirmatory assays to confirm true positive results. Samples that are positive in the screening assay underwent further testing in the confirmatory assay to determine if patients are true positive. Samples that are positive in the ADA confirmatory assay were analyzed further to conduct a NAb assessment. | Analysis was performed based on Safety Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Immunogenicity Result at Week 24 | Anti-drug Antibody test involved both screening and confirmatory assays to confirm true positive results. Samples that are positive in the screening assay underwent further testing in the confirmatory assay to determine if patients are true positive. Samples that are positive in the ADA confirmatory assay were analyzed further to conduct a NAb assessment. | Analysis was performed based on Safety-TP2 Subset which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II. | Posted | Count of Participants | Participants | Week 24 |
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| 0 |
| 203 |
| 4 |
| 203 |
| 22 |
| 203 |
| EG001 | Arm 2/ Treatment Period 1 | Received 300 mg of EU-approved Xolair as SC injections via PFS in TP1 EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution | 0 | 205 | 2 | 205 | 23 | 205 |
| EG002 | Arm 3/ Treatment Period 1 | Received 150mg of CT-P39 as SC injections via PFS in TP1 CT-P39: Prefilled syringe (PFS) of 1 mL solution | 0 | 107 | 2 | 107 | 16 | 107 |
| EG003 | Arm 4/ Treatment Period 1 | Received 150 mg of EU-approved Xolair as SC injections via PFS in TP1 EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution | 0 | 103 | 3 | 103 | 12 | 103 |
| EG004 | Arm 1/Treatment Period 2 | Received 300 mg of CT-P39 as SC injections via PFS in Treatment Period 1 (TP1) and maintained CT-P39 300 mg in Treatment Period 2 (TP2) CT-P39: Prefilled syringe (PFS) of 1 mL solution | 1 | 187 | 5 | 187 | 16 | 187 |
| EG005 | Arm 2-1/ Treatment Period 2 | Received 300 mg of EU-approved Xolair as SC injection via PFS in TP1 and switched to CT-P39 300 mg in TP2 CT-P39: Prefilled syringe (PFS) of 1 mL solution EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution | 0 | 96 | 0 | 96 | 8 | 96 |
| EG006 | Arm 2-2/Treatment Period 2 | Received 300 mg of EU-approved Xolair as SC injection via PFS in TP1 and maintained Xolair 300 mg in TP2 EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution | 0 | 96 | 2 | 96 | 10 | 96 |
| EG007 | Arm 3/ Treatment Period 2 | Received 150 mg of CT-P39 as SC injections via PFS in TP1 and increased to CT-P39 300 mg in TP2 CT-P39: Prefilled syringe (PFS) of 1 mL solution | 0 | 101 | 0 | 101 | 8 | 101 |
| EG008 | Arm 4/ Treatment Period 2 | Received 150 mg of EU-approved Xolair as SC injections via PFS in TP1 and increased to Xolair 300 mg in TP2 EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution | 0 | 98 | 0 | 98 | 5 | 98 |
| EG009 | Arm 1/Follow-up Period | Received 300 mg of CT-P39 as SC injections via PFS in Treatment Period 1 (TP1) CT-P39: Prefilled syringe (PFS) of 1 mL solution | 0 | 203 | 1 | 203 | 8 | 203 |
| EG010 | Arm 2/Follow-up Period | Received 300 mg of EU-approved Xolair as SC injections via PFS in TP1 EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution | 0 | 205 | 4 | 205 | 17 | 205 |
| EG011 | Arm 3/Follow-up Period | Received 150mg of CT-P39 as SC injections via PFS in TP1 CT-P39: Prefilled syringe (PFS) of 1 mL solution | 0 | 107 | 3 | 107 | 8 | 107 |
| EG012 | Arm 4/Follow-up Period | Received 150 mg of EU-approved Xolair as SC injections via PFS in TP1 EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution | 0 | 103 | 0 | 103 | 7 | 103 |
| Colitis | Gastrointestinal disorders | Meddra 25.1 | Systematic Assessment |
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| Femoral hernia | Gastrointestinal disorders | Meddra 25.1 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | Meddra 25.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | Meddra 25.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | Meddra 25.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | Meddra 25.1 | Systematic Assessment |
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| Coronavirus infection | Infections and infestations | Meddra 25.1 | Systematic Assessment |
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| Infection | Infections and infestations | Meddra 25.1 | Systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | Meddra 25.1 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | Meddra 25.1 | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | Meddra 25.1 | Systematic Assessment |
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| Tryptase increased | Investigations | Meddra 25.1 | Systematic Assessment |
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| Arthropathy | Musculoskeletal and connective tissue disorders | Meddra 25.1 | Systematic Assessment |
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| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Meddra 25.1 | Systematic Assessment |
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| Completed suicide | Psychiatric disorders | Meddra 25.1 | Systematic Assessment |
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| Cervical dysplasia | Reproductive system and breast disorders | Meddra 25.1 | Systematic Assessment |
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| Menometrorrhagia | Reproductive system and breast disorders | Meddra 25.1 | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | Meddra 25.1 | Systematic Assessment |
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| Behcet's syndrome | Vascular disorders | Meddra 25.1 | Systematic Assessment |
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| Chronic Tonsillitis | Infections and infestations | Meddra 25.1 | Systematic Assessment |
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| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Meddra 25.1 | Systematic Assessment |
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| Ureteric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Meddra 25.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | Meddra 25.1 | Systematic Assessment |
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| Headache | Nervous system disorders | Meddra 25.1 | Systematic Assessment |
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| Immunisation reaction | Immune system disorders | Meddra 25.1 | Systematic Assessment |
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| Injection site reaction | General disorders | Meddra 25.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Meddra 25.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Meddra 25.1 | Systematic Assessment |
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Not provided
Not provided
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Patients with UAS7 = 0 |
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| Patients with UAS7 = 0 |
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| NAb positive (in ADA positive patients) |
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| NAb positive (in ADA positive patients) |
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