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This is a phase II, open-label, multicenter study of the efficacy and safety of sequential administration of CVP x 6 followed by tositumomab and iodine I 131 tositumomab (formerly referred to as tositumomab and iodine I 131 tositumomab). All patients who complete three cycles of CVP, regardless of response, will be eligible for treatment with tositumomab and iodine I 131 tositumomab. Subjects who have rapidly progressive disease prior to completing three cycles of CVP may be removed from study.
In order to proceed to tositumomab and iodine I 131 tositumomab therapy, patients must have completed six cycles of CVP within 20 weeks as described. Patients may proceed to Iodine-131 Anti-B1 Antibody if they have progressive disease documented at the response evaluation following 6 cycles of CVP. In addition, patients must still meet the eligibility inclusion exclusion criteria based upon the week 20 assessments, as applicable. Patients must also have an average of ≤25% bone marrow involved by NHL to receive treatment with tositumomab and iodine I 131 tositumomab. The dosimetric dose of tositumomab and iodine I 131 tositumomab must be given within 28 days of the response evaluation following CVP and no later than 56 days from the first day of the sixth cycle of CVP.
This is a phase II, open-label, multicenter study of the efficacy and safety sequential administration of cycolophosphamide, vacristine, and prednisone (CVP) x6 cycles followed by tositumomab and iodine I 131 tositumomab for previously untreated subjects with low-grade Non-Hodgkin's Lymphoma (NHL). CVP will be repeated every 21 days for a total of six cycles. tositumomab and iodine I 131 tositumomab will begin within 56 days following the first day of the sixth cycle of CVP. Subjects will undergo two dosing phase for the tositumomab and iodine I 131 tositumomab therapy. In the first phase, "dosimetric dose", patients will receive an infusion of unlabeled Anti-B1 Antibody (450mg) over 60 minutes followed by a 30 minute infusion (including a 10-minutes flush) of Anti-B1 (35mg) containing 5mCi of Iodine-131. Whole body gamma camera scans will be obtained on Day 0; Day 2, 3, or 4 and Day 6 or 7 following the dosimetric dose. Using the dosimetric data from three time points, a patient-specific dose of Iodine-131 will be calculated to deliver the desired total body dose of radiotherapy. In the second phase, termed the "therapeutic dose", patients will receive 60-minute infusion of unlabeled Anti-B1 Antibody (450 mg) followed by a 30-minute infusion (including a 10-minute flush) of 35 mg Anti-B1 Antibody labeled with the subjects -specific dose of Iodine-131 calculate to deliver a 75cGy total body radiation dose. Subjects who have platelet counts of 100,000-149,999 cells/mm3 will receive 65 cGy; obese patients will be dosed base upon 137% of their lean body mass. Subjects will be treated with saturated solution potassium iodide (SSKI), Lugol's solution, or potassium iodide tablets starting at least 24 hours prior to the first infusion of the tositumomab and iodine I 131 tositumomab (i.e., the dosimetric dose) and continuing for 14 days following the least infusion of tositumomab and iodine I 131 tositumomab (i.e., the therapeutic dose).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open-label, single arm | Experimental | cycolophosphamide, vacristine, and pednisone (CVP) x6 cycles followed by tositumomab and iodine I 131 tositumomab. CVP will be repeated every 21 days for a total of six cycles. tositumomab and iodine I 131 tositumomab will begin within 56 days following the first day of the sixth cycle of CVP. Patient will undergo two dosing phase for the tositumomab and iodine I 131 tositumomab therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cycolophosphamide, vacristine, and pednisone (CVP) x6 cycles followed by tositumomab and iodine I 131 tositumomab. | Biological | cycolophosphamide, vacristine, and pednisone (CVP) x6 cycles followed by tositumomab and iodine I 131 tositumomab. CVP will be repeated every 21 days for a total of six cycles. tositumomab and iodine I 131 tositumomab will begin within 56 days following the first day of the sixth cycle of CVP. Patient will undergo two dosing phase for the tositumomab and iodine I 131 tositumomab therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants (Par.) With Unconfirmed Response (Complete Response, Complete Response/Unconfirmed, or Partial Response), 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), Complete Response/unconfirmed (CRu: complete resolution of all disease-related symptoms; residual lymph node mass >1.5 centimeters in the greatest transverse diameter that has regressed by >75%, indeterminate bone marrow, 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). | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
| Number of Participants (Par.) With Confirmed Response (Complete Response [CR], Complete Response/Unconfirmed [CRu], or Partial Response [PR]), as Assessed by the Investigator | CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. CRu: complete resolution of all disease-related symptoms; residual lymph node mass >1.5 centimeters in the greatest transverse diameter that has regressed by >75%, indeterminate bone marrow, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. Confirmed response required CR, CRu, or PR, which were confirmed by 2 separate response evaluations >=4 weeks apart. | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Unconfirmed Complete Response (CR), as Assessed by the Investigator | CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy. | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20458031 | Background | Link BK, Martin P, Kaminski MS, Goldsmith SJ, Coleman M, Leonard JP. Cyclophosphamide, vincristine, and prednisone followed by tositumomab and iodine-131-tositumomab in patients with untreated low-grade follicular lymphoma: eight-year follow-up of a multicenter phase II study. J Clin Oncol. 2010 Jun 20;28(18):3035-41. doi: 10.1200/JCO.2009.27.8325. Epub 2010 May 10. |
| 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 |
|---|---|---|---|
| 104514 | Informed Consent Form | 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 cyclophosphamide (C), vincristine (V), prednisone (P) in the first study phase (P). Upon completion of this P, par. began the first of 2 phases of radio immunotherapy: P1, dosimetric dose (DD); P2, therapeutic dose. Par. completing 2 years of the study could enter a long-term follow-up study (BEX104528; NCT00240578).
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy; TST and Iodine I 131 TST | Par. received 6 cycles of chemotherapy (chemo.): oral Cyclophosphamide (400 milligrams/meters squared [mg/m^2]/day) for 1-5 days; intravenous (IV) Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled tositumomab (TST) (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) Iodine 131. Par. received 4 drops by mouth (DBM) 3 times a day (TID) of potassium iodide (KI) and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the therapeutic dose (TD: a 1 hour IV infusion of 450 mg TST), followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Dosimetric and Therapeutic Treatment |
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| Number of Participants With Confirmed Complete Response (CR), as Assessed by the Investigator | CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy. Confirmed response required CR, which was confirmed by 2 separate response evaluations >=4 weeks apart. | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
| Duration of Response (DOR), as Assessed by the Investigator | DOR=the time from the first documented response (for par. with CR, CRu, or PR) until disease progression (DP). DP=a >=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) 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 >1.5 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
| DOR for Unconfirmed and Confirmed Complete Response, as Assessed by the Investigator | DOR=the time from the first documented response (for par. with CR) until disease progression (DP). DP=a >=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) 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 >1.5 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
| Time to Progression of Disease or Death, as Assessed by the Investigator | Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. Disease progression is defined as a >=50% increase from the nadir value (lowest laboratory value recorded following administration of the study medication) 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 >1.5 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination. | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
| Time to Treatment Failure, as Assessed by the Investigator | Time to treatment failure is defined as the time from the start of treatment to the first occurrence of study withdrawal, progression, or death. | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
| Total Body Residence Time (TBRT; Average Amount of Time TST Spends in the Body, Calculated From the Rate of TB Clearance of Radioactivity During the Dosimetric Dose [DD]) of Iodine 131 TST Antibody Following the DD | To determine TBRT, the percent-injected activity (PIA) is calculated from the background-corrected (BC) total body count (TBC) at D 0; D 2/3/4; and D 7. The time from the DD to the acquisition of whole body count (WBC) is then determined. The PIA remaining at each time point (TP) is then calculated by dividing the BC WBC for that TP by the BC WBC from the first TP (D 0) * 100. To determine RT, a best-fit line from 100% (pre-plotted D 0 value) through 2 plotted points (other TPs) is made. TBRT=the x-axis value at the point where the line intersects the horizontal 37% injected activity line. | Day (D) 0; D 2, 3, or 4; and D 6 or 7 |
| Time to Nadir for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, Platelets, and White Blood Cell (WBC) Count | Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose). | Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose) |
| Time to Recovery (TTR) to Baseline (BL) for Hematologic Laboratory (Lab.) Evaluations | TTR to BL grade (gr.) for par. with a Gr. 0 toxicity (tox.=lab. value outside the normal range) at BL=time from the last administration of study drug (SD) to the first post-nadir (PN) date with Gr. 0 toxicity with no other Gr. 1-4 toxicities recorded within the next week. For par. with a higher gr. tox. at BL, TTR=time from the last administration of SD to the first PN date with the BL gr. or better with no other higher gr. toxicities recorded during the next week. Each lab. established its own reference range using data from its own equipment/methods; there is no standard reference range. | Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose) |
| Nadir Values for Absolute Neutrophil Count (ANC) | Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose). | Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose) |
| Nadir Values for Hemoglobin | Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose). | Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose) |
| Nadir Values for Platelet Count | Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose). | Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose) |
| Nadir Values for WBC Count | Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose). | Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose) |
| Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) | AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
| Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug | AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. The Investigator assessed whether the AE was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities (values outside the normal range) were assumed to be possibly or probably related to study drug. | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
| Number of Participants With Any Treatment-related Serious Adverse Event (SAE) | An SAE is defined as any event occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience (at immediate risk of death from the experience as it occurred), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious adverse drug experience when based upon appropriate medical judgment. | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
| Number of Participants With the Indicated Primary Cause of Death | The primary cause of death of the participants was assessed by the Investigator. | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
| Number of Participants Who Received Any Supportive Care | Supportive care is defined as interventions that help the participants achieve comfort but do not affect the course of a disease. | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
| Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Study Entry) But Positive or Negative at Month 24 | The administration of murine antibodies may form HAMA. A HAMA assay was performed using the ImmunoSTRIP HAMA IgG enzyme-linked immune absorbent assay by a central laboratory (Covance Classic Laboratory Services, Indianapolis, IN). To be "positive," a participant had to have a positive HAMA assessment during the first 24 months. | Day 1 to Day 730 (24 months) after receiving the dosimetric dose |
| Overall Survival | Overall survival is defined as the time from the treatment start date to the date of death from any cause. | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 104514 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104514 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104514 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104514 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104514 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104514 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
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| Long-Term Follow-Up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy; TST and Iodine I 131 TST | Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given. |
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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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants (Par.) With Unconfirmed Response (Complete Response, Complete Response/Unconfirmed, or Partial Response), 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), Complete Response/unconfirmed (CRu: complete resolution of all disease-related symptoms; residual lymph node mass >1.5 centimeters in the greatest transverse diameter that has regressed by >75%, indeterminate bone marrow, 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). | Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for response were analyzed. | Posted | Number | participants | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
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| Primary | Number of Participants (Par.) With Confirmed Response (Complete Response [CR], Complete Response/Unconfirmed [CRu], or Partial Response [PR]), as Assessed by the Investigator | CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. CRu: complete resolution of all disease-related symptoms; residual lymph node mass >1.5 centimeters in the greatest transverse diameter that has regressed by >75%, indeterminate bone marrow, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. Confirmed response required CR, CRu, or PR, which were confirmed by 2 separate response evaluations >=4 weeks apart. | Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for response were analyzed. | Posted | Number | participants | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
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| Secondary | Number of Participants With Unconfirmed Complete Response (CR), as Assessed by the Investigator | CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy. | ITT Exposed Population | Posted | Number | participants | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
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| Secondary | Number of Participants With Confirmed Complete Response (CR), as Assessed by the Investigator | CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy. Confirmed response required CR, which was confirmed by 2 separate response evaluations >=4 weeks apart. | ITT Exposed Population | Posted | Number | participants | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
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| Secondary | Duration of Response (DOR), as Assessed by the Investigator | DOR=the time from the first documented response (for par. with CR, CRu, or PR) until disease progression (DP). DP=a >=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) 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 >1.5 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. | ITT Exposed Population. Only those participants with response were analyzed. Participants who did not experience progression were censored. | Posted | Median | 95% Confidence Interval | months | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
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| Secondary | DOR for Unconfirmed and Confirmed Complete Response, as Assessed by the Investigator | DOR=the time from the first documented response (for par. with CR) until disease progression (DP). DP=a >=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) 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 >1.5 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. | ITT Exposed Population. Only those participants with response were analyzed. Participants who did not experience progression were censored. | Posted | Median | 95% Confidence Interval | months | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
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| Secondary | Time to Progression of Disease or Death, as Assessed by the Investigator | Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. Disease progression is defined as a >=50% increase from the nadir value (lowest laboratory value recorded following administration of the study medication) 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 >1.5 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination. | ITT Exposed Population. If a participant did not have progression or did not die, that participant was censored in the survival analysis. | Posted | Median | 95% Confidence Interval | months | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
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| Secondary | Time to Treatment Failure, as Assessed by the Investigator | Time to treatment failure is defined as the time from the start of treatment to the first occurrence of study withdrawal, progression, or death. | ITT Exposed Population. If a participant did not have treatment failure, that participant was censored in the survival analysis. | Posted | Median | 95% Confidence Interval | months | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
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| Secondary | Total Body Residence Time (TBRT; Average Amount of Time TST Spends in the Body, Calculated From the Rate of TB Clearance of Radioactivity During the Dosimetric Dose [DD]) of Iodine 131 TST Antibody Following the DD | To determine TBRT, the percent-injected activity (PIA) is calculated from the background-corrected (BC) total body count (TBC) at D 0; D 2/3/4; and D 7. The time from the DD to the acquisition of whole body count (WBC) is then determined. The PIA remaining at each time point (TP) is then calculated by dividing the BC WBC for that TP by the BC WBC from the first TP (D 0) * 100. To determine RT, a best-fit line from 100% (pre-plotted D 0 value) through 2 plotted points (other TPs) is made. TBRT=the x-axis value at the point where the line intersects the horizontal 37% injected activity line. | ITT Exposed Population | Posted | Mean | Standard Deviation | hours | Day (D) 0; D 2, 3, or 4; and D 6 or 7 |
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| Secondary | Time to Nadir for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, Platelets, and White Blood Cell (WBC) Count | Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose). | ITT Exposed Population | Posted | Median | Full Range | days | Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose) |
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| Secondary | Time to Recovery (TTR) to Baseline (BL) for Hematologic Laboratory (Lab.) Evaluations | TTR to BL grade (gr.) for par. with a Gr. 0 toxicity (tox.=lab. value outside the normal range) at BL=time from the last administration of study drug (SD) to the first post-nadir (PN) date with Gr. 0 toxicity with no other Gr. 1-4 toxicities recorded within the next week. For par. with a higher gr. tox. at BL, TTR=time from the last administration of SD to the first PN date with the BL gr. or better with no other higher gr. toxicities recorded during the next week. Each lab. established its own reference range using data from its own equipment/methods; there is no standard reference range. | ITT Exposed Population. Only those participants with hematologic toxicity were evaluated for time to recovery to baseline. | Posted | Median | 95% Confidence Interval | days | Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose) |
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| Secondary | Nadir Values for Absolute Neutrophil Count (ANC) | Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose). | ITT Exposed Population | Posted | Median | Full Range | 10^3 cells/cubic millimeters (mm^3) | Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose) |
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| Secondary | Nadir Values for Hemoglobin | Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose). | ITT Exposed Population | Posted | Median | Full Range | Grams/deciliter (g/dL) | Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose) |
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| Secondary | Nadir Values for Platelet Count | Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose). | ITT Exposed Population | Posted | Median | Full Range | 10^3 cells/microliter (µL) | Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose) |
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| Secondary | Nadir Values for WBC Count | Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose). | ITT Exposed Population | Posted | Median | Full Range | 10^3 cells/µL | Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose) |
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| Secondary | Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) | AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. | ITT Exposed Population | Posted | Number | participants | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
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| Secondary | Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug | AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. The Investigator assessed whether the AE was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities (values outside the normal range) were assumed to be possibly or probably related to study drug. | ITT Exposed Population | Posted | Number | participants | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
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| Secondary | Number of Participants With Any Treatment-related Serious Adverse Event (SAE) | An SAE is defined as any event occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience (at immediate risk of death from the experience as it occurred), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious adverse drug experience when based upon appropriate medical judgment. | ITT-Exposed Population. All participants who experienced a treatment-related SAE were analyzed. | Posted | Number | participants | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
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| Secondary | Number of Participants With the Indicated Primary Cause of Death | The primary cause of death of the participants was assessed by the Investigator. | ITT Exposed Population. All participants who died during the study were analyzed. | Posted | Number | participants | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
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| Secondary | Number of Participants Who Received Any Supportive Care | Supportive care is defined as interventions that help the participants achieve comfort but do not affect the course of a disease. | ITT-Exposed Population | Posted | Number | participants | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
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| Secondary | Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Study Entry) But Positive or Negative at Month 24 | The administration of murine antibodies may form HAMA. A HAMA assay was performed using the ImmunoSTRIP HAMA IgG enzyme-linked immune absorbent assay by a central laboratory (Covance Classic Laboratory Services, Indianapolis, IN). To be "positive," a participant had to have a positive HAMA assessment during the first 24 months. | ITT Exposed Population | Posted | Number | participants | Day 1 to Day 730 (24 months) after receiving the dosimetric dose |
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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. | ITT Exposed Population | Posted | Median | 95% Confidence Interval | months | Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528. |
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Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from both Study BEX104514 and Study BEX104528.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Period After CVP | Par. received 6 cycles of chemotherapy as follows: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; intravenous Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days | 7 | 30 | 30 | 30 | ||
| EG001 | Period After Dosimetric and Therapeutic Dose | After receiving Cyclophosphamide, Vincristine, and Prednisone, par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled tositumomab (TST) (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) Iodine 131. Par. received 4 drops by mouth (DBM) 3 times a day (TID) of potassium iodide (KI) and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the therapeutic dose (TD: a 1 hour IV infusion of 450 mg TST), followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. | 8 | 30 | 30 | 30 | ||
| EG002 | Combined Regimen Period | Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given. | 13 | 30 | 30 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | 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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| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Acute myeloid leukaemia | 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 |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Perirectal abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cystitis hemorrhagic | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANC <1000 cells/mm^3 | Investigations | MedDRA | Systematic Assessment |
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| WBC <2000 cells/mm^3 | Investigations | MedDRA | Systematic Assessment |
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| Platelets <50000 cells/mm^3 | Investigations | MedDRA | Systematic Assessment |
| |
| Hemoglobin <8.0 g/dL | Investigations | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Chills | General disorders | MedDRA | Systematic Assessment |
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| Asthenia | General disorders | MedDRA | Systematic Assessment |
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| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
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| Crepitations | General disorders | MedDRA | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA | Systematic Assessment |
| |
| Ill-defined disorder | General disorders | MedDRA | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA | Systematic Assessment |
| |
| Suprapubic pain | General disorders | MedDRA | Systematic Assessment |
| |
| Xerosis | General disorders | MedDRA | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Increased tendency to bruise | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Scab | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin tightness | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hyporeflexia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Anal pruritus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Parotid gland enlargement | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Salivary gland disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Swollen tongue | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Tongue discolouration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Tongue ulceration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal mucosal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Tonsillar disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle hypertrophy | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscular weakness | 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 |
| |
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Emotional distress | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Hypervigilance | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Bladder irritation | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Body temperature decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA | Systematic Assessment |
| |
| Heart rate irregular | Investigations | MedDRA | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA | Systematic Assessment |
| |
| Amenorrhea | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hematoma | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Adenoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 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 |
|---|---|
| C034588 | COP protocol 2 |
| C119496 | tositumomab I-131 |
Not provided
Not provided
Not provided
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