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Study RIT-II-001 is a phase II, multicenter study of the safety, tumor and organ dosimetry, dosimetry methods, and efficacy of Iodine-131 Anti-B1 Antibody for the treatment of patients with low-grade or transformed low-grade non-Hodgkin's lymphoma (NHL). The primary objective of this study is to demonstrate that each site could accurately conduct the whole body dosimetry required for the safe and effective dosing of Iodine-131 Anti-B1 Antibody. Additional objectives of this study are to evaluate the efficacy, dosimetry, and safety of Iodine-131 Anti-B1 Antibody.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tositumomab and Iodine I-131 Tositumomab | Experimental | Patients receive a dosimetric dose consisting of 450 milligrams (mg) of unlabeled tositumomab (TST, Anti-B1 Antibody) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after administration and then daily for the next 7 days were used to determine the radioactive clearance and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose. The therapeutic dose was administered 7-14 days after the dosimetric dose and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tositumomab (Anti-B1 Antibody) and Iodine-131 Tositumomab | Biological | Patients receive a dosimetric dose consisting of 450 milligrams (mg) of unlabeled tositumomab (TST, Anti-B1 Antibody) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after administration and then daily for the next 7 days were used to determine the radioactive clearance and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose. The therapeutic dose was administered 7-14 days after the dosimetric dose and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Received the Therapeutic Dose at the Seven Clinical Research Sites | The dosimetry methods were validated for seven different clinical research sites. | Day 1 within one hour of infusion (I) and prior to urination (U); Days 2, 3, and 4 after dosimetric dose (DD) I, following U; Days 6 and 7 after DD I, following U |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Indicated Therapeutic Doses (TD) (Total Body Dose) | Based on their platelet count and body weight. Participants received different TDs of TST. For obese participants (weighing more than 137% of their calculated lean body weight), the calculation to determine the administered activity (mCi) was performed using the maximum effective mass (i.e., the minimum of the participant's mass and 137% of their calculated lean body weight). The administered activity (mCi) for participants with a Baseline platelet count of 100001-149999 cells/millimeter cubed (mm^3) was reduced to a 65 cGy total body dose, after any adjustment for obesity. |
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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 |
|---|---|---|---|
| 104731 | Study Protocol | 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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Participants (par.) received radioimmunotherapy of tositumomab (TST) and Iodine I 131 TST in 2 phases (Ph.): Ph. 1, dosimetric dose; Ph. 2, therapeutic dose. Par. were evaluated until disease progression, they died, or they were on study for 2 years. Par. completing 2 years of study could enter a long-term follow-up study (BEX104526; NCT00240591).
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| ID | Title | Description |
|---|---|---|
| FG000 | TST and Iodine I 131 TST | Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Dosimetric and Therapeutic Treatment |
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| Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
| Number of Participants (Par.) With Response (CR, CCR, or PR), as Assessed by the Investigator | Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
| Number of Participants With Confirmed Response (CR, CCR, or PR), as Assessed by the Investigator | Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
| Number of Participants With CR and CCR, as Assessed by the Investigator | The total number of participants with CR and CCR was reported. CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Clinical Complete Response: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
| Number of Participants With Confirmed CR and CCR, as Assessed by the Investigator | The total number of participants with CR and CCR was reported. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Clinical Complete Response: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
| Duration of Response for All Confirmed Responders (CR, CCR, or PR), as Assessed by the Investigator | Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression 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 >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination. | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
| Duration of Response for All Unconfirmed Responders (CR, CCR, or PR), as Assessed by the Investigator | Duration of response is defined as the time from the first documented response until disease progression. Disease progression 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 >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination. | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
| Duration of Response for All Confirmed Complete Responders, as Assessed by the Investigator | Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression 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 >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination. | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
| Duration of Response for All Unconfirmed Complete Responders, as Assessed by the Investigator | Duration of response is defined as the time from the first documented response until disease progression. Disease progression 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 >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination. | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
| Duration of Response for All Confirmed Clinical Complete Responders, as Assessed by the Investigator | Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression 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 >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination. | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
| Duration of Response for All Unconfirmed Clinical Complete Responders, as Assessed by the Investigator | Duration of response is defined as the time from the first documented response until disease progression. Disease progression 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 >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination. | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
| Median Time to Treatment Failure for All Participants | Time to treatment failure is defined as the length of time from the date of enrollment to the first incidence of treatment withdrawal, study removal, progression, and/or alternative therapy for the participant's lymphoma, or death. | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
| Overall Survival | Overall survival is defined as the time from the treatment start date to the date of death from any cause. Time to death is the time from the dosimetric dose to the date of death. | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
| Time to Disease Progression or Death for Responders, as Assessed by the Investigator | Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
| Time to Disease Progression or Death for All Participants, as Assessed by the Investigator | Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
For additional information about this study please refer to the GSK Clinical Study Register |
| 104731 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104731 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104731 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104731 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104731 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104731 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
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| NOT COMPLETED |
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| Long-Term Follow-Up |
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| ID | Title | Description |
|---|---|---|
| BG000 | TST and Iodine I 131 TST | Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Gender | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| 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 Who Received the Therapeutic Dose at the Seven Clinical Research Sites | The dosimetry methods were validated for seven different clinical research sites. | Intent-to-Treat (ITT) Exposed Population: all participants who enrolled in the study and received at least one dose of study drug. One participant did not receive the therapeutic dose. | Posted | Number | participants | Day 1 within one hour of infusion (I) and prior to urination (U); Days 2, 3, and 4 after dosimetric dose (DD) I, following U; Days 6 and 7 after DD I, following U |
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| Secondary | Number of Participants With the Indicated Therapeutic Doses (TD) (Total Body Dose) | Based on their platelet count and body weight. Participants received different TDs of TST. For obese participants (weighing more than 137% of their calculated lean body weight), the calculation to determine the administered activity (mCi) was performed using the maximum effective mass (i.e., the minimum of the participant's mass and 137% of their calculated lean body weight). The administered activity (mCi) for participants with a Baseline platelet count of 100001-149999 cells/millimeter cubed (mm^3) was reduced to a 65 cGy total body dose, after any adjustment for obesity. | ITT Exposed Population | Posted | Number | participants | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
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| Secondary | Number of Participants (Par.) With Response (CR, CCR, or PR), as Assessed by the Investigator | Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). | ITT Exposed Population. Only those participants evaluable for response were analyzed. | Posted | Number | participants | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
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| Secondary | Number of Participants With Confirmed Response (CR, CCR, or PR), as Assessed by the Investigator | Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). | ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed. | Posted | Number | participants | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
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| Secondary | Number of Participants With CR and CCR, as Assessed by the Investigator | The total number of participants with CR and CCR was reported. CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Clinical Complete Response: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. | ITT Exposed Population. Only those participants evaluable for response were analyzed. | Posted | Number | participants | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
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| Secondary | Number of Participants With Confirmed CR and CCR, as Assessed by the Investigator | The total number of participants with CR and CCR was reported. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Clinical Complete Response: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. | ITT Exposed Population. Only those participants evaluable for confirmed CR and CCR were analyzed. | Posted | Number | participants | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
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| Secondary | Duration of Response for All Confirmed Responders (CR, CCR, or PR), as Assessed by the Investigator | Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression 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 >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination. | ITT Exposed Population. Only those participants with a confirmed response were analyzed. | Posted | Median | 95% Confidence Interval | months | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
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| Secondary | Duration of Response for All Unconfirmed Responders (CR, CCR, or PR), as Assessed by the Investigator | Duration of response is defined as the time from the first documented response until disease progression. Disease progression 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 >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination. | ITT Exposed Population. Only those participants with a confirmed response were analyzed. | Posted | Median | 95% Confidence Interval | months | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
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| Secondary | Duration of Response for All Confirmed Complete Responders, as Assessed by the Investigator | Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression 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 >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination. | ITT Exposed Population. Only those participants with a confirmed CR were analyzed. | Posted | Median | 95% Confidence Interval | months | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
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| Secondary | Duration of Response for All Unconfirmed Complete Responders, as Assessed by the Investigator | Duration of response is defined as the time from the first documented response until disease progression. Disease progression 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 >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination. | ITT Exposed Population. Only those participants with a confirmed CR were analyzed. | Posted | Median | 95% Confidence Interval | months | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
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| Secondary | Duration of Response for All Confirmed Clinical Complete Responders, as Assessed by the Investigator | Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression 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 >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination. | ITT Exposed Population. Only those participants with a confirmed CCR were analyzed. | Posted | Median | 95% Confidence Interval | months | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
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| Secondary | Duration of Response for All Unconfirmed Clinical Complete Responders, as Assessed by the Investigator | Duration of response is defined as the time from the first documented response until disease progression. Disease progression 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 >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination. | ITT Exposed Population. Only those participants with a confirmed CCR were analyzed. | Posted | Median | 95% Confidence Interval | months | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
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| Secondary | Median Time to Treatment Failure for All Participants | Time to treatment failure is defined as the length of time from the date of enrollment to the first incidence of treatment withdrawal, study removal, progression, and/or alternative therapy for the participant's lymphoma, or death. | ITT Exposed Population | Posted | Median | 95% Confidence Interval | months | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
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| Secondary | Overall Survival | Overall survival is defined as the time from the treatment start date to the date of death from any cause. Time to death is the time from the dosimetric dose to the date of death. | ITT Exposed Population. Only those participants who died during the study were analyzed. | Posted | Median | 95% Confidence Interval | months | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
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| Secondary | Time to Disease Progression or Death for Responders, as Assessed by the Investigator | Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. | ITT Exposed Population. Only participants classified as responders with disease progression or those who died were analyzed. | Posted | Median | 95% Confidence Interval | months | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months |
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| Secondary | Time to Disease Progression or Death for All Participants, as Assessed by the Investigator | Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. | ITT Exposed Population. Only participants with disease progression or those who died were analyzed. | Posted | Median | 95% Confidence Interval | months | Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 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 | TST and Iodine I 131 TST | Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years. | 23 | 47 | 46 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myelodysplastic Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Acute Myeloid Leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Bladder Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Breast Cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Lip and/or Oral Cavity Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Lung Squamous Cell Carcinoma Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Skin Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Tongue Neoplasm Malignant Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Disseminated Intravascular Coagulation | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Abdominal Strangulated Hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Anal Fissure | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal Hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Device Related Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumococcal Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary Tract Infection Enterococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Chills | General disorders | MedDRA | Systematic Assessment |
| |
| Multi-Organ Failure | General disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Serum Sickness | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Erythema Nodosum | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Edema Peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Chills | General disorders | MedDRA | Systematic Assessment |
| |
| Local Swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Mucous Membrane Disorder | General disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Catheter Site Erythema | General disorders | MedDRA | Systematic Assessment |
| |
| Catheter Site Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA | Systematic Assessment |
| |
| Feeling Abnormal | General disorders | MedDRA | Systematic Assessment |
| |
| Gait Disturbance | General disorders | MedDRA | Systematic Assessment |
| |
| Hunger | General disorders | MedDRA | Systematic Assessment |
| |
| Infusion Site Extravasation | General disorders | MedDRA | Systematic Assessment |
| |
| Localized Edema | General disorders | MedDRA | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA | Systematic Assessment |
| |
| Multi-Organ Failure | General disorders | MedDRA | Systematic Assessment |
| |
| Absolute Neutrophill Count (ANC) <1000 cells/cubic millim(cm | Investigations | MedDRA | Systematic Assessment |
| |
| Platelets < 50,000 cells/cmm | Investigations | MedDRA | Systematic Assessment |
| |
| WBC (White Blood Cells) < 2,000 cells/cmm | Investigations | MedDRA | Systematic Assessment |
| |
| Hemoglobin < 8.0 grams/deciliter (g/dL) | Investigations | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal Strangulated Hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal Tenderness | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Anal Fissure | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal Hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastroesophageal Reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Rectal Fissure | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bacterial Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Device Related Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes Virus Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infusion Site Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumococcal Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pseudomonas Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary Tract Infection Enterococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Post Herpetic Neuralgia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Sensory Disturbance | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Choking Sensation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal Blistering | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pharyngeal Erythema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleuritic Pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash Erythematous | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Blood Blister | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Erythema Nodosum | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash Pruritic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Disseminated Intravascular Coagulation | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Limb Discomfort | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in Jaw | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Myelodysplastic Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Acute Myeloid Leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Bladder Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Breast Cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lip and/or Oral Cavity Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung Squamous Cell Carcinoma Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Skin Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Tongue Neoplasm Malignant Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Ear Discomfort | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Serum Sickness | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Anaphylactic Reaction | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood Thyroid Stimulating Hormone Increased | Investigations | MedDRA | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Ureteric Obstruction | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
| |
| Periorbital Edema | Eye disorders | MedDRA | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Vaginal Lesion | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Spinocerebellar Ataxia | Congenital, familial and genetic disorders | MedDRA | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C119496 | tositumomab I-131 |
Not provided
Not provided
Not provided
| Black |
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