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This multicenter study will determine the response rate, the complete response rate, duration of response, time to progression, time-to-treatment failure, safety, and survival following treatment with Iodine-131 Anti-B1 Antibody for the retreatment of patients with non-Hodgkin's lymphoma who previously responded with a duration of response of at least 3 months to Iodine-131 Anti-B1 Antibody therapy. Patients will undergo two phases of study. In the first phase, patients will receive a dosimetric dose of unlabeled Anti-B1 Antibody (450 mg) followed by Anti-B1 Antibody (35 mg) which has been radiolabeled with 5 mCi of Iodine-131. Whole body gamma camera scans will be obtained after the dosimetric dose and data from three imaging time points will be used to calculate a patient-specific dose to deliver the desired total body dose of radiotherapy. In the second phase, patients will receive the therapeutic dose of unlabeled Anti-B1 Antibody (450 mg) followed by 35 mg of Anti-B1 Antibody labeled with the patient-specific dose to deliver the desired whole body dose of radiation. Patients will be treated with thyroid blocking medication at least 24 hours prior to the first infusion and continuing for 14 days following the last infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retreatment of NHL with Iodine-131 Anti-B1 Antibody | Experimental | Patients with non-Hodgkin's lymphoma who previously responded with a duration of response of at least 3 months to Iodine-131 Anti-B1 Antibody therapy will undergo two phases of study. In the first phase, patients will receive a dosimetric dose of unlabeled Anti-B1 Antibody (450 mg) followed by Anti-B1 Antibody (35 mg) which has been radiolabeled with 5 mCi of Iodine-131. Whole body gamma camera scans will be obtained after the dosimetric dose and data from three imaging time points will be used to calculate a patient-specific dose to deliver the desired total body dose of radiotherapy. In the second phase, patients will receive the therapeutic dose of unlabeled Anti-B1 Antibody (450 mg) followed by 35 mg of Anti-B1 Antibody labeled with the patient-specific dose to deliver the desired whole body dose of radiation. Patients will be treated with thyroid blocking medication at least 24 hours prior to the first infusion and continuing for 14 days following the last infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tositumomab and Iodine I 131 Tositumomab | Biological | Tositumomab and Iodine I 131 Tositumomab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Response and Confirmed Complete Response | Complete response (CR) is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Response is defined as the best response achieved at any evaluation. A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart. | Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months) |
| Duration of Response for All Confirmed Responders (CR + CCR + PR) | For participants with CR, clinical CR (CCR), or partial response (PR), duration of response is defined as the time from the first documented response to the first documented progression. CCR is defined as the complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion <=2 centimeters (cm) in diameter by radiographic evaluation or <=1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations and, if unchanged or if further decreases for 6 months or longer are present, the participant will then be reclassified as a CR (complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease). PR is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions. | Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months) |
| Progression-free Survival | Progression-free survival (time to progression or death) is defined as the time from the start of retreatment (i.e., the dosimetric dose) to the first documented progression or death. Disease Progression (PD) is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be grater than 2 cm diameter by radiographic evaluation or grater than 1 cm diameter by physical examination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 393229/010 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab | Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab | Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush. |
| 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 | Number of Participants With Complete Response and Confirmed Complete Response | Complete response (CR) is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Response is defined as the best response achieved at any evaluation. A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart. | ITT-Exposed Population: all participants who received at least one dose of study drug | Posted | Number | Participants | Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months) |
|
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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 | Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab | Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA, version 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C119496 | tositumomab I-131 |
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| Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months) |
| Time to Treatment Failure | Time to treatment failure is defined as the time from the dosimetric dose to the first occurrence of treatment withdrawal, a decision to receive additional therapy, study withdrawal, disease progression, or death. | Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months) |
| Overall Survival | Time to death (overall survival) is defined as the time from the start of retreatment (i.e., the dosimetric dose) to the date of death from any cause. | Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months) |
| Number of Participants With Any Serious Adverse Event (SAE) and Adverse Event (AE) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; or resulted in disability, congenital anomaly, or cancer. Refer to the general AE/SAE module for a complete list of all AEs and SAEs. | Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months) |
For additional information about this study please refer to the GSK Clinical Study Register |
| 393229/010 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 393229/010 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 393229/010 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 393229/010 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 393229/010 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 393229/010 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Death |
|
| Adrenal Insufficiency |
|
| Years |
|
| Gender | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
|
|
|
| Primary | Duration of Response for All Confirmed Responders (CR + CCR + PR) | For participants with CR, clinical CR (CCR), or partial response (PR), duration of response is defined as the time from the first documented response to the first documented progression. CCR is defined as the complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion <=2 centimeters (cm) in diameter by radiographic evaluation or <=1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations and, if unchanged or if further decreases for 6 months or longer are present, the participant will then be reclassified as a CR (complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease). PR is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions. | ITT-Exposed Population. Only those participants with a confirmed CR, CCR, or PR were analyzed. | Posted | Median | 95% Confidence Interval | Months | Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months) |
|
|
|
| Primary | Progression-free Survival | Progression-free survival (time to progression or death) is defined as the time from the start of retreatment (i.e., the dosimetric dose) to the first documented progression or death. Disease Progression (PD) is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be grater than 2 cm diameter by radiographic evaluation or grater than 1 cm diameter by physical examination. | ITT-Exposed Population. Participants who did not progress or die were censored at their date of last contact in the study. | Posted | Median | 95% Confidence Interval | Months | Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months) |
|
|
|
| Primary | Time to Treatment Failure | Time to treatment failure is defined as the time from the dosimetric dose to the first occurrence of treatment withdrawal, a decision to receive additional therapy, study withdrawal, disease progression, or death. | ITT-Exposed Population. Participants who withdrew from the study for reasons other than progression or death were censored at the date of study withdrawal. Participants who did not meet any of the criteria for treatment failure were censored at their date of last contact in the study. | Posted | Median | 95% Confidence Interval | Months | Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months) |
|
|
|
| Primary | Overall Survival | Time to death (overall survival) is defined as the time from the start of retreatment (i.e., the dosimetric dose) to the date of death from any cause. | ITT-Exposed Population. Participants who did not die were censored at the date of their last contact in the study. | Posted | Median | 95% Confidence Interval | Months | Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months) |
|
|
|
| Primary | Number of Participants With Any Serious Adverse Event (SAE) and Adverse Event (AE) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; or resulted in disability, congenital anomaly, or cancer. Refer to the general AE/SAE module for a complete list of all AEs and SAEs. | ITT-Exposed Population | Posted | Number | Participants | Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months) |
|
|
|
| 18 |
| 32 |
| 31 |
| 32 |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 16.0 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 16.0 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 16.0 | Systematic Assessment |
|
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 16.0 | Systematic Assessment |
|
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 16.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Caecitis | Gastrointestinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA, version 16.0 | Systematic Assessment |
|
| Pseudomonal sepsis | Infections and infestations | MedDRA, version 16.0 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA, version 16.0 | Systematic Assessment |
|
| Lymphomatoid papulosis | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA, version 16.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Axillary pain | General disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Tongue eruption | Gastrointestinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| White blood cell < 2000 cells/mm^3 | Investigations | MedDRA, version 16.0 | Systematic Assessment |
|
| Absolute neutrophil count < 1000 cells/mm^3 | Investigations | MedDRA, version 16.0 | Systematic Assessment |
|
| Platelets < 50000 cells/mm^3 | Investigations | MedDRA, version 16.0 | Systematic Assessment |
|
| Hemoglobin < 8.0 grams/deciliter | Investigations | MedDRA, version 16.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA, version 16.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA, version 16.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA, version 16.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA, version 16.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA, version 16.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA, version 16.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA, version 16.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA, version 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Mental impairment | Nervous system disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Axillary mass | Musculoskeletal and connective tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA, version 16.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA, version 16.0 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA, version 16.0 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA, version 16.0 | Systematic Assessment |
|
| Breath sounds abnormal | Investigations | MedDRA, version 16.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Pupillary reflex impaired | Eye disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Strabismus | Eye disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Stress urinary incontinence | Renal and urinary disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA, version 16.0 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA, version 16.0 | Systematic Assessment |
|
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.
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |