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Eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as the Churg-Strauss syndrome, is a systemic necrotizing vasculitis that affects small and medium sized blood vessels. NUCALA® (mepolizumab 300 milligrams [mg], subcutaneous administration) was approved in Japan in 2018 for the treatment of EGPA in adult participants. This is a single-arm, multi-center, prospective, non-interventional study that aims to assess long-term (2 to 4 years) real-world safety and effectiveness of NUCALA. Approximately 120 participants who completed the NUCALA Post Marketing Surveillance (PMS) study (National Clinical Trial [NCT]03557060) will be enrolled in the study.
NUCALA is a registered trademark of GlaxoSmithKline (GSK) group of companies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with EGPA who have received NUCALA treatment | Data will be collected of participants who have already received NUCALA for 96 weeks in routine clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESI) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with study participation, whether or not considered related to study participation. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, and other situations which involve medical or scientific judgment. An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. AESIs included Hypersensitivity (including anaphylaxis), Infections and Malignant tumors. | Up to 96 weeks |
| Number of Participants With Adverse Drug Reactions (ADRs) | An ADR is defined as an AE for which the investigator classifies the possible relationship to study intervention as "Yes". ADRs related to NUCALA were collected. | Up to 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Symptoms | Clinical symptoms as assessed by 9 organ-systems (i.e. systemic, skin, mucous membranes/eyes, ears/nose/throat, chest, cardiovascular, abdominal, renal, nervous system [motor and sensory]) relevant to EGPA in systemic vasculitis were assessed. Data were summarized for following categories; none, active, worsening, active + worsening. "None" is defined as absence of clinical symptoms. "Active disease" is defined as follows: The participant has clinical symptoms, or worsening of symptoms is noted as compared to those in the preceding observation period and the status in the preceding observation period was assessed as "None". "Worsening" is defined as follows: The participant has worsening clinical symptoms, or worsening of symptoms is noted as compared to those in the preceding observation period and the status in the preceding observation period was assessed as "Active disease" or "Worsening". Percentage values are rounded off. |
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Inclusion Criteria:
Adult participants with EGPA of >=20 years of age inclusive, at the time of signing the informed consent.
Participants must have a current clinical diagnosis of EGPA by physician.
Participants have continuously used NUCALA for at least 96 weeks for the treatment of EGPA as mentioned in the current label in Japan.
• Participants thus were registered and completed the NUCALA PMS study (special drug use investigation; Protocol Number 208505, NCT03557060) prior to be enrolled in this study.
Physician's decision to continue treatment with NUCALA for the treatment of EGPA as mentioned in the current label in Japan.
Prior to commencing any study related activities, participants must be able and willing to provide written informed consent.
Exclusion Criteria:
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Adult participants with EGPA who have already received NUCALA treatment for 96 weeks after its market launch in Japan.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aichi | 489-8642 | Japan | |||
| GSK Investigational Site |
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A total of 118 participants were enrolled in the study.
This non-interventional study aims to assess the long-term safety and effectiveness of NUCALA in the real-world setting in participants with Eosinophilic granulomatosis with polyangiitis (EGPA) who have already used NUCALA for 96 weeks after its market launch in Japan and who completed the NUCALA Post marketing surveillance (PMS) study 208505 (NCT03557060).
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With EGPA Who Have Received Mepolizumab 300 mg | Participants with EGPA who have already received mepolizumab 300 milligrams (mg) subcutaneously (SC) for 96 weeks after its market launch in Japan and who completed the NUCALA Post marketing surveillance (PMS) study (Protocol 208505 [NCT03557060]) were included in this observational study. No study treatment was administered in current study (NCT04551989). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jul 27, 2020 | Apr 25, 2024 |
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| At 96 weeks |
| Percentage of Participants With Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | EGPA relapse is defined as any of the following with worsening EGPA: increased dose of oral corticosteroids (OCS), initiation/increased dose of immuno-suppressive agents or EGPA treatment with hospitalization. Percentage of participants with EGPA relapse were reported. Percentage values are rounded off. | Up to 96 weeks |
| Annualized Rate of Hospitalization for EGPA-related Events | Annualized rate of hospitalization = (Number of corresponding hospital visits * 365)/ (number of days in the observation period). The annualized rate and associated 95 percent (%) confidence intervals (CIs) were calculated using a negative binomial generalized linear model with logarithm of time as an offset variable, without covariate. Number (estimated event per person year) and 95% CI were reported. | Up to 96 weeks |
| Annualized Rate of Emergency Room/Unscheduled Visit for EGPA-related Events | Annualized rate of Emergency Room/Unscheduled Visit = (Number of corresponding Emergency Room/Unscheduled Visits * 365)/(number of days in the observation period). The annualized rate and associated 95% CIs were calculated using a negative binomial generalized linear model with logarithm of time as an offset variable, without covariate. Number (estimated event per person year) and 95% CI were reported. | Up to 96 weeks |
| Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) | Average daily dose of OCS for each participant was calculated by 12-weekly periods as: Total dosage of OCS (mg) / Total duration of administration of OCS (day). Total duration of administration is defined as: Last date of period minus later date of (first date of each period or start date of OCS) +1. | Week 0, Weeks 9-12, Weeks 21-24, Weeks 33-36, Weeks 45-48, Weeks 57-60, Weeks 69-72, Weeks 81-84, Weeks 93-96 |
| Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Number of participants by each category of average daily prednisolone-equivalent of OCS were assessed. The dosing categories included: zero, greater than (>)0 to less than or equal to (<=) 4.0 milligrams per day (mg/day), >4.0 to <=7.5 mg/day, >7.5 mg/day. | Week 0, Weeks 9-12, Weeks 21-24, Weeks 33-36, Weeks 45-48, Weeks 57-60, Weeks 69-72, Weeks 81-84, Weeks 93-96 |
| Gunma |
| 371-8511 |
| Japan |
| GSK Investigational Site | Hyōgo | 653-0013 | Japan |
| GSK Investigational Site | Hyōgo | 670-8520 | Japan |
| GSK Investigational Site | Hyōgo | 674-0063 | Japan |
| GSK Investigational Site | Hyōgo | 675-8611 | Japan |
| GSK Investigational Site | Ishikawa | 920-8530 | Japan |
| GSK Investigational Site | Ishikawa | 923-8560 | Japan |
| GSK Investigational Site | Kanagawa | 216-8511 | Japan |
| GSK Investigational Site | Kanagawa | 241-0801 | Japan |
| GSK Investigational Site | Kanagawa | 241-0811 | Japan |
| GSK Investigational Site | Kanagawa | 252-0392 | Japan |
| GSK Investigational Site | Kochi | 780-8522 | Japan |
| GSK Investigational Site | Mie | 510-8567 | Japan |
| GSK Investigational Site | Mie | 511-0061 | Japan |
| GSK Investigational Site | Miyagi | 980-8574 | Japan |
| GSK Investigational Site | Osaka | 533-0024 | Japan |
| GSK Investigational Site | Osaka | 534-0021 | Japan |
| GSK Investigational Site | Saitama | 350-8550 | Japan |
| GSK Investigational Site | Shiga | 520-2192 | Japan |
| GSK Investigational Site | Shizuoka | 430-8525 | Japan |
| GSK Investigational Site | Shizuoka | 436-8555 | Japan |
| GSK Investigational Site | Tokyo | 104-8560 | Japan |
| GSK Investigational Site | Tokyo | 113-8431 | Japan |
| GSK Investigational Site | Tokyo | 113-8603 | Japan |
| GSK Investigational Site | Tokyo | 113-8655 | Japan |
| GSK Investigational Site | Tokyo | 173-8606 | Japan |
| GSK Investigational Site | Tokyo | 183-8524 | Japan |
| GSK Investigational Site | Tokyo | 190-0014 | Japan |
| GSK Investigational Site | Tokyo | 194-0023 | Japan |
| GSK Investigational Site | Tokyo | 204-8585 | Japan |
| GSK Investigational Site | Tottori | 680-0833 | Japan |
| GSK Investigational Site | Wakayama | 640-8558 | Japan |
| GSK Investigational Site | Yamaguchi | 755-8505 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With EGPA Who Have Received Mepolizumab 300 mg | Participants with EGPA who have already received mepolizumab 300 milligrams (mg) subcutaneously (SC) for 96 weeks after its market launch in Japan and who completed the NUCALA Post marketing surveillance (PMS) study (Protocol 208505 [NCT03557060]) were included in this observational study. No study treatment was administered in current study (NCT04551989). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | 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 | Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESI) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with study participation, whether or not considered related to study participation. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, and other situations which involve medical or scientific judgment. An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. AESIs included Hypersensitivity (including anaphylaxis), Infections and Malignant tumors. | Treated Population (TP) included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA. | Posted | Count of Participants | Participants | Up to 96 weeks |
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| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Drug Reactions (ADRs) | An ADR is defined as an AE for which the investigator classifies the possible relationship to study intervention as "Yes". ADRs related to NUCALA were collected. | Treated Population | Posted | Count of Participants | Participants | Up to 96 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Symptoms | Clinical symptoms as assessed by 9 organ-systems (i.e. systemic, skin, mucous membranes/eyes, ears/nose/throat, chest, cardiovascular, abdominal, renal, nervous system [motor and sensory]) relevant to EGPA in systemic vasculitis were assessed. Data were summarized for following categories; none, active, worsening, active + worsening. "None" is defined as absence of clinical symptoms. "Active disease" is defined as follows: The participant has clinical symptoms, or worsening of symptoms is noted as compared to those in the preceding observation period and the status in the preceding observation period was assessed as "None". "Worsening" is defined as follows: The participant has worsening clinical symptoms, or worsening of symptoms is noted as compared to those in the preceding observation period and the status in the preceding observation period was assessed as "Active disease" or "Worsening". Percentage values are rounded off. | Treated Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Posted | Number | Percentage of Participants | At 96 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | EGPA relapse is defined as any of the following with worsening EGPA: increased dose of oral corticosteroids (OCS), initiation/increased dose of immuno-suppressive agents or EGPA treatment with hospitalization. Percentage of participants with EGPA relapse were reported. Percentage values are rounded off. | Treated Population | Posted | Number | Percentage of Participants | Up to 96 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Annualized Rate of Hospitalization for EGPA-related Events | Annualized rate of hospitalization = (Number of corresponding hospital visits * 365)/ (number of days in the observation period). The annualized rate and associated 95 percent (%) confidence intervals (CIs) were calculated using a negative binomial generalized linear model with logarithm of time as an offset variable, without covariate. Number (estimated event per person year) and 95% CI were reported. | Treated Population | Posted | Number | 95% Confidence Interval | Events per Person-year | Up to 96 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Annualized Rate of Emergency Room/Unscheduled Visit for EGPA-related Events | Annualized rate of Emergency Room/Unscheduled Visit = (Number of corresponding Emergency Room/Unscheduled Visits * 365)/(number of days in the observation period). The annualized rate and associated 95% CIs were calculated using a negative binomial generalized linear model with logarithm of time as an offset variable, without covariate. Number (estimated event per person year) and 95% CI were reported. | Treated Population | Posted | Number | 95% Confidence Interval | Events per Person-year | Up to 96 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) | Average daily dose of OCS for each participant was calculated by 12-weekly periods as: Total dosage of OCS (mg) / Total duration of administration of OCS (day). Total duration of administration is defined as: Last date of period minus later date of (first date of each period or start date of OCS) +1. | Treated Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Posted | Median | Full Range | Milligrams | Week 0, Weeks 9-12, Weeks 21-24, Weeks 33-36, Weeks 45-48, Weeks 57-60, Weeks 69-72, Weeks 81-84, Weeks 93-96 |
|
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| Secondary | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Number of participants by each category of average daily prednisolone-equivalent of OCS were assessed. The dosing categories included: zero, greater than (>)0 to less than or equal to (<=) 4.0 milligrams per day (mg/day), >4.0 to <=7.5 mg/day, >7.5 mg/day. | Treated Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Posted | Count of Participants | Participants | Week 0, Weeks 9-12, Weeks 21-24, Weeks 33-36, Weeks 45-48, Weeks 57-60, Weeks 69-72, Weeks 81-84, Weeks 93-96 |
|
|
All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96
Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
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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 | Participants With EGPA Who Have Received Mepolizumab 300 mg | Participants with EGPA who have already received mepolizumab 300 milligrams (mg) subcutaneously (SC) for 96 weeks after its market launch in Japan and who completed the NUCALA Post marketing surveillance (PMS) study (Protocol 208505 [NCT03557060]) were included in this observational study. No study treatment was administered in current study (NCT04551989). | 3 | 118 | 26 | 118 | 23 | 118 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Enterocolitis viral | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gastric varices haemorrhage | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Systematic Assessment |
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| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Systematic Assessment |
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| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Systematic Assessment |
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| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
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| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
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| Aortic aneurysm | Vascular disorders | MedDRA v26.0 | Systematic Assessment |
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| Aortic dissection | Vascular disorders | MedDRA v26.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
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| Goitre | Endocrine disorders | MedDRA v26.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA v26.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA v26.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA v26.0 | Systematic Assessment |
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| Rectal ulcer | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 17, 2023 | Apr 25, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015267 | Churg-Strauss Syndrome |
| ID | Term |
|---|---|
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| D056647 | Systemic Vasculitis |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006099 | Granuloma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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