Trial Outcomes & Findings for Study of Radiolabeled Monoclonal Antibody Anti-B1 for the Treatment of B-Cell Lymphomas and Extended Study to Determine the Safety and Efficacy of Coulter Clone® 131Iodine-B1 Radioimmunotherapy of Advanced Non-Hodgkin's Lymphoma (NCT NCT01536561)
NCT ID: NCT01536561
Last Updated: 2017-08-31
Results Overview
Par. (groups of 3-6) received the TD at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (par. who had bone marrow transplantation), increasing by 10 cGy increments at each dose level, until the maximum tolerated dose (MTD) was achieved. The MTD was defined as the highest dose level at which 0/3 or 1/6 par. experienced dose-limiting toxicity (DLT): any Grade 4 hematologic toxicity (National Cancer Institute criteria) lasting \>7 days, any Grade 3 hematologic toxicity lasting \>2 weeks, or any Grade 3/4 nonhematologic toxicity. Not Applicable (NA) indicates that no par. were re-dosed.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
59 participants
Primary outcome timeframe
Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
Results posted on
2017-08-31
Participant Flow
After an initial treatment (IT), 14 participants (14 of the 59 particpants receiving the IT) who achieved a partial or complete response and subsequently developed progressive disease were retreated (administered at either the initial dose or a reduced dose if a \>=Grade toxicity had occurred after the IT) at the time of disease progression.
Participants received radioimmunotherapy of tositumomab (TST) and Iodine I 131 TST in 2 phases: Phase 1, dosimetric dose; Phase 2, therapeutic dose. After radioimmunotherapy, participants could have entered a 10-year Long-Term Follow-Up study (Study BEX104526; NCT00240591) for continued evaluation.
Participant milestones
| Measure |
TST and Iodine I 131 TST
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
|---|---|
|
Dosimetric and Therapeutic Treatment
STARTED
|
59
|
|
Dosimetric and Therapeutic Treatment
COMPLETED
|
0
|
|
Dosimetric and Therapeutic Treatment
NOT COMPLETED
|
59
|
|
Long-Term Follow-Up
STARTED
|
13
|
|
Long-Term Follow-Up
COMPLETED
|
13
|
|
Long-Term Follow-Up
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
TST and Iodine I 131 TST
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
|---|---|
|
Dosimetric and Therapeutic Treatment
Progressive Disease
|
40
|
|
Dosimetric and Therapeutic Treatment
Received Alternate Treatment
|
2
|
|
Dosimetric and Therapeutic Treatment
Adverse Event
|
1
|
|
Dosimetric and Therapeutic Treatment
Lost to Follow-up
|
1
|
|
Dosimetric and Therapeutic Treatment
Death
|
2
|
|
Dosimetric and Therapeutic Treatment
Enrolled in Study BEX104526
|
13
|
Baseline Characteristics
Study of Radiolabeled Monoclonal Antibody Anti-B1 for the Treatment of B-Cell Lymphomas and Extended Study to Determine the Safety and Efficacy of Coulter Clone® 131Iodine-B1 Radioimmunotherapy of Advanced Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
TST and Iodine I 131 TST
n=59 Participants
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
|---|---|
|
Age, Continuous
|
49.9 Years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
54 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.Population: Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug.
Par. (groups of 3-6) received the TD at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (par. who had bone marrow transplantation), increasing by 10 cGy increments at each dose level, until the maximum tolerated dose (MTD) was achieved. The MTD was defined as the highest dose level at which 0/3 or 1/6 par. experienced dose-limiting toxicity (DLT): any Grade 4 hematologic toxicity (National Cancer Institute criteria) lasting \>7 days, any Grade 3 hematologic toxicity lasting \>2 weeks, or any Grade 3/4 nonhematologic toxicity. Not Applicable (NA) indicates that no par. were re-dosed.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=59 Participants
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Number of Participants (Par.) During Initial Treatment Exposed to the Indicated Dose Levels of the Therapeutic Dose (TD), Re-dose, and Total Dose (TD + Re-dose)
TD=0cGy+Re-dose=NA; Total=0cGy
|
6 participants
|
—
|
|
Number of Participants (Par.) During Initial Treatment Exposed to the Indicated Dose Levels of the Therapeutic Dose (TD), Re-dose, and Total Dose (TD + Re-dose)
TD=25cGy+Re-dose=NA; Total=25cGy
|
1 participants
|
—
|
|
Number of Participants (Par.) During Initial Treatment Exposed to the Indicated Dose Levels of the Therapeutic Dose (TD), Re-dose, and Total Dose (TD + Re-dose)
TD=25cGy+Re-dose=25cGy; Total=50cGy
|
2 participants
|
—
|
|
Number of Participants (Par.) During Initial Treatment Exposed to the Indicated Dose Levels of the Therapeutic Dose (TD), Re-dose, and Total Dose (TD + Re-dose)
TD=35cGy+Re-dose=NA; Total=35cGy
|
4 participants
|
—
|
|
Number of Participants (Par.) During Initial Treatment Exposed to the Indicated Dose Levels of the Therapeutic Dose (TD), Re-dose, and Total Dose (TD + Re-dose)
TD=45cGy+Re-dose=NA; Total=45cGy
|
8 participants
|
—
|
|
Number of Participants (Par.) During Initial Treatment Exposed to the Indicated Dose Levels of the Therapeutic Dose (TD), Re-dose, and Total Dose (TD + Re-dose)
TD=45cGy+Re-dose=45cGy; Total=90cGy
|
1 participants
|
—
|
|
Number of Participants (Par.) During Initial Treatment Exposed to the Indicated Dose Levels of the Therapeutic Dose (TD), Re-dose, and Total Dose (TD + Re-dose)
TD=55cGy+Re-dose=NA; Total=55cGy
|
8 participants
|
—
|
|
Number of Participants (Par.) During Initial Treatment Exposed to the Indicated Dose Levels of the Therapeutic Dose (TD), Re-dose, and Total Dose (TD + Re-dose)
TD=65cGy+Re-dose=NA; Total=65cGy
|
5 participants
|
—
|
|
Number of Participants (Par.) During Initial Treatment Exposed to the Indicated Dose Levels of the Therapeutic Dose (TD), Re-dose, and Total Dose (TD + Re-dose)
TD=65cGy+Re-dose=65cGy; Total 130cGy
|
1 participants
|
—
|
|
Number of Participants (Par.) During Initial Treatment Exposed to the Indicated Dose Levels of the Therapeutic Dose (TD), Re-dose, and Total Dose (TD + Re-dose)
TD=75cGy+Re-dose=NA; Total=75cGy
|
18 participants
|
—
|
|
Number of Participants (Par.) During Initial Treatment Exposed to the Indicated Dose Levels of the Therapeutic Dose (TD), Re-dose, and Total Dose (TD + Re-dose)
TD=75cGy+Re-dose=65cGy; Total=140cGy
|
1 participants
|
—
|
|
Number of Participants (Par.) During Initial Treatment Exposed to the Indicated Dose Levels of the Therapeutic Dose (TD), Re-dose, and Total Dose (TD + Re-dose)
TD=75cGy+Re-dose=75cGy; Total=150cGy
|
1 participants
|
—
|
|
Number of Participants (Par.) During Initial Treatment Exposed to the Indicated Dose Levels of the Therapeutic Dose (TD), Re-dose, and Total Dose (TD + Re-dose)
TD=85cGy+Re-dose=NA; Total=85cGy
|
3 participants
|
—
|
PRIMARY outcome
Timeframe: Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.Population: ITT Exposed Population
Retreatment was administered to participants either at the initial TD of TST/I 131 TST or at a reduced dose if a \>=Grade 2 toxicity had occurred after initial treatment, until the MTD was achieved. The MTD was defined as the highest dose level at which 0/3 or 1/6 participants experienced DLT: any Grade 4 hematologic toxicity (National Cancer Institute criteria) lasting \>7 days, any Grade 3 hematologic toxicity lasting \>2 weeks, or any Grade 3/4 nonhematologic toxicity. Not Applicable (NA) indicates that no participants were re-dosed.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=14 Participants
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Number of Participants During Retreatment Exposed to the Indicated Dose Levels of the TD, Re-dose, and Total Dose (TD + Re-dose)
TD=25cGy+Re-dose=NA; Total=25cGy
|
1 participants
|
—
|
|
Number of Participants During Retreatment Exposed to the Indicated Dose Levels of the TD, Re-dose, and Total Dose (TD + Re-dose)
TD=35cGy+Re-dose=NA; Total=35cGy
|
1 participants
|
—
|
|
Number of Participants During Retreatment Exposed to the Indicated Dose Levels of the TD, Re-dose, and Total Dose (TD + Re-dose)
TD=38cGy+Re-dose=NA; Total=38cGy
|
2 participants
|
—
|
|
Number of Participants During Retreatment Exposed to the Indicated Dose Levels of the TD, Re-dose, and Total Dose (TD + Re-dose)
TD=45cGy+Re-dose=NA; Total=45cGy
|
1 participants
|
—
|
|
Number of Participants During Retreatment Exposed to the Indicated Dose Levels of the TD, Re-dose, and Total Dose (TD + Re-dose)
TD=45cGy+Re-dose=45cGy; Total=90cGy
|
1 participants
|
—
|
|
Number of Participants During Retreatment Exposed to the Indicated Dose Levels of the TD, Re-dose, and Total Dose (TD + Re-dose)
TD=55cGy+Re-dose=NA; Total=55cGy
|
2 participants
|
—
|
|
Number of Participants During Retreatment Exposed to the Indicated Dose Levels of the TD, Re-dose, and Total Dose (TD + Re-dose)
TD=60cGy+Re-dose=NA; Total=60cGy
|
1 participants
|
—
|
|
Number of Participants During Retreatment Exposed to the Indicated Dose Levels of the TD, Re-dose, and Total Dose (TD + Re-dose)
TD=65cGy+Re-dose=NA; Total=65cGy
|
2 participants
|
—
|
|
Number of Participants During Retreatment Exposed to the Indicated Dose Levels of the TD, Re-dose, and Total Dose (TD + Re-dose)
TD=75cGy+Re-dose=NA; Total=75cGy
|
3 participants
|
—
|
PRIMARY outcome
Timeframe: Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.Population: ITT Exposed Population
Participants who had prior bone marrow transplantation (BMT) initiated TD at 65 cGy TBD, whereas those who had no prior BMT initiated TD at 25 cGy TBD. The MTD was defined as the highest dose level at which 0/3 or 1/6 par. experienced DLT: any Grade 4 hematologic toxicity (National Cancer Institute criteria) lasting \>7 days, any Grade 3 hematologic toxicity lasting \>2 weeks, or any Grade 3/4 nonhematologic toxicity. Not Applicable (NA) indicates that no par. were re-dosed.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=59 Participants
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Maximum Tolerated Dose (MTD) of TST/I 131 TST Evaluated in the Study
Participants who had not undergone BMT
|
75 Total body radiation dose in cGy
|
—
|
|
Maximum Tolerated Dose (MTD) of TST/I 131 TST Evaluated in the Study
Participants who had undergone BMT
|
45 Total body radiation dose in cGy
|
—
|
PRIMARY outcome
Timeframe: Serial anterior and posterior gamma whole body scans were obtained 1 hour after the administration of the dosimetric dose (on Day 0), and then daily for at least 5 days until Day 7Population: ITT Exposed Population. Of the 59 participants analyzed, 23 received 2 or 3 dosimetric doses (DD); tumor/organ dosimetry was calculated for all 86 DD. The "n" in the category title reflects the number of DD, which will differ for each target organ depending on whether adequate gamma camera images were available for analysis after each of the 86 DD.
Serial whole body sodium iodide scintillation probe counts were obtained from participants approximately 1 hour after the administration of the dosimetric dose and then daily for at least 5 days. Gamma camera images of participants were used to calculate the amount of radiation that accumulated in the target tumor and normal organs (tumor/organ dosimetry). Spleen volume may vary based on disease status, and volume correction allows for a comparison of spleen dose across participants.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=86 dosimetric doses
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Tumor/Organ Dosimetry of TST/I 131 TST for All Predoses (Initial Treatment)
Spleen (volume-corrected), n=77
|
477.68 cGy/75 cGy TBD
Standard Deviation 235.95
|
—
|
|
Tumor/Organ Dosimetry of TST/I 131 TST for All Predoses (Initial Treatment)
Tumor (average), n=57
|
1074.27 cGy/75 cGy TBD
Standard Deviation 704.8
|
—
|
|
Tumor/Organ Dosimetry of TST/I 131 TST for All Predoses (Initial Treatment)
Kidney (average), n=46
|
607.57 cGy/75 cGy TBD
Standard Deviation 185.66
|
—
|
|
Tumor/Organ Dosimetry of TST/I 131 TST for All Predoses (Initial Treatment)
Liver (average), n=46
|
261.26 cGy/75 cGy TBD
Standard Deviation 72.03
|
—
|
|
Tumor/Organ Dosimetry of TST/I 131 TST for All Predoses (Initial Treatment)
Lungs (average), n=46
|
192.35 cGy/75 cGy TBD
Standard Deviation 67.53
|
—
|
|
Tumor/Organ Dosimetry of TST/I 131 TST for All Predoses (Initial Treatment)
Urine Bladder Wall (average), n=86
|
242.59 cGy/75 cGy TBD
Standard Deviation 93.24
|
—
|
|
Tumor/Organ Dosimetry of TST/I 131 TST for All Predoses (Initial Treatment)
Bone marrow (average), n=38
|
101.25 cGy/75 cGy TBD
Standard Deviation 16.10
|
—
|
|
Tumor/Organ Dosimetry of TST/I 131 TST for All Predoses (Initial Treatment)
Blood (average), n=42
|
368.60 cGy/75 cGy TBD
Standard Deviation 96.30
|
—
|
|
Tumor/Organ Dosimetry of TST/I 131 TST for All Predoses (Initial Treatment)
Testes (average), n=45
|
58.06 cGy/75 cGy TBD
Standard Deviation 6.14
|
—
|
|
Tumor/Organ Dosimetry of TST/I 131 TST for All Predoses (Initial Treatment)
Ovaries (average), n=20
|
71.03 cGy/75 cGy TBD
Standard Deviation 4.42
|
—
|
SECONDARY outcome
Timeframe: Serial anterior and posterior gamma whole body scans were obtained 1 hour after the administration of the dosimetric dose (on Day 0), and then daily for at least 5 days until Day 7Population: ITT Exposed Population. Participants who received unlabelled doses of 0 mg, 95 mg, or 475 mg were analyzed. Of the 59 participants analyzed, 23 received 2 or 3 dosimetric doses (DD); tumor/organ dosimetry was calculated for all 86 DD. The "n" in the category title reflects the number of DD, which will differ for each target organ.
The effect of unlabeled TST pre-treatment on targeting of radioactive TST was evaluated. Serial whole body sodium iodide scintillation probe counts were obtained from participants approximately 1 hour after the administration of the dosimetric dose (DD) and then daily for at least 5 days. Initially, participants received either two or three DDs, each of which was preceded by a pre-dose of unlabeled tositumomab (0, 95, or 475 mg) to determine the dose of unlabeled tositumomab that optimized the radiation dose to tumor. The tumor radiation absorbed dose was determined using gamma camera images.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=86 dosimetric doses
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Tumor/Organ Dosimetry at the Indicated Predoses of 475 mg, 95 mg, and 0 mg (Initial Treatment)
475 mg Predose, Spleen (volume-corrected); n=36
|
411.5 cGy/75 cGy TBD
Standard Deviation 217.40
|
—
|
|
Tumor/Organ Dosimetry at the Indicated Predoses of 475 mg, 95 mg, and 0 mg (Initial Treatment)
475 mg Predose, Tumor (average); n=28
|
1023.04 cGy/75 cGy TBD
Standard Deviation 711.44
|
—
|
|
Tumor/Organ Dosimetry at the Indicated Predoses of 475 mg, 95 mg, and 0 mg (Initial Treatment)
95 mg Predose, Spleen (volume-corrected); n=21
|
451.77 cGy/75 cGy TBD
Standard Deviation 238.40
|
—
|
|
Tumor/Organ Dosimetry at the Indicated Predoses of 475 mg, 95 mg, and 0 mg (Initial Treatment)
95 mg Predose, Tumor (average); n=14
|
1177.3 cGy/75 cGy TBD
Standard Deviation 650.3
|
—
|
|
Tumor/Organ Dosimetry at the Indicated Predoses of 475 mg, 95 mg, and 0 mg (Initial Treatment)
0 mg, Spleen (volume-corrected); n=20
|
624 cGy/75 cGy TBD
Standard Deviation 210.26
|
—
|
|
Tumor/Organ Dosimetry at the Indicated Predoses of 475 mg, 95 mg, and 0 mg (Initial Treatment)
0 mg, Tumor (average); n=15
|
1073.75 cGy/75 cGy TBD
Standard Deviation 776.1
|
—
|
SECONDARY outcome
Timeframe: Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.Population: ITT Exposed Population. Only those participants evaluable for response were analyzed.
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).
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=57 Participants
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
n=14 Participants
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Number of Participants (Par.) With the Indicated Response as Assessed by the Investigator
CCR
|
0 participants
|
0 participants
|
|
Number of Participants (Par.) With the Indicated Response as Assessed by the Investigator
CR
|
20 participants
|
4 participants
|
|
Number of Participants (Par.) With the Indicated Response as Assessed by the Investigator
PR
|
22 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.Population: ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.
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).
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=44 Participants
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
n=9 Participants
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator
Confirmed CR
|
20 participants
|
4 participants
|
|
Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator
Confirmed CCR
|
0 participants
|
0 participants
|
|
Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator
Confirmed PR
|
9 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.Population: ITT Exposed Population. Only those participants with unconfirmed response (CR, CCR, or PR) and those who experienced progressive disease were analyzed.
Duration of response is defined as the time from the first documented response until disease progression.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=42 Participants
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
n=8 Participants
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Duration of Response for All Unconfirmed Responders (CR, CCR, or PR) as Assessed by the Investigator
|
8.5 months
Interval 4.1 to 13.0
|
7.7 months
Interval 4.4 to 96.5
|
SECONDARY outcome
Timeframe: Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.Population: ITT Exposed Population. Only those participants who experienced progression were evaluated.
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.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=55 Participants
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
n=14 Participants
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Time to Progression of Disease or Death
|
5.7 months
Interval 3.4 to 8.3
|
4.9 months
Interval 1.6 to 12.8
|
SECONDARY outcome
Timeframe: Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.Population: ITT Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.
Overall survival is defined as the time from the treatment start date to the date of death from any cause.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=33 Participants
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
n=12 Participants
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Overall Survival
|
46.4 months
Interval 30.0 to 92.8
|
45.0 months
Interval 7.4 to 103.6
|
SECONDARY outcome
Timeframe: Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion.Population: ITT Exposed Population. The sample size ("n") in the category titles is the number of infusions (dosing occasions) with parameter results.
t1/2 alpha is the estimated initial or alpha phase half-life in a two-compartmental pharmacokinetic model . t1/2 beta is the estimated terminal or beta phase half-life in a two-compartmental pharmacokinetic model; also denoted as t1/2. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=161 infusions
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Half-life: Initial Half-life (t1/2 Alpha) and Terminal Half-life (t1/2 Beta) of I 131 TST for the Antibody Predose Levels of 0 mg, 95 mg, and 475 mg
0 mg, t1/2 alpha, n=24
|
6.2 hours (hr)
Standard Deviation 5.7
|
—
|
|
Half-life: Initial Half-life (t1/2 Alpha) and Terminal Half-life (t1/2 Beta) of I 131 TST for the Antibody Predose Levels of 0 mg, 95 mg, and 475 mg
95 mg, t1/2 alpha, n=34
|
6.0 hours (hr)
Standard Deviation 6.5
|
—
|
|
Half-life: Initial Half-life (t1/2 Alpha) and Terminal Half-life (t1/2 Beta) of I 131 TST for the Antibody Predose Levels of 0 mg, 95 mg, and 475 mg
475 mg, t1/2 alpha, n=96
|
6.7 hours (hr)
Standard Deviation 6.8
|
—
|
|
Half-life: Initial Half-life (t1/2 Alpha) and Terminal Half-life (t1/2 Beta) of I 131 TST for the Antibody Predose Levels of 0 mg, 95 mg, and 475 mg
0 mg, terminal t1/2 beta, n=24
|
63.2 hours (hr)
Standard Deviation 51.5
|
—
|
|
Half-life: Initial Half-life (t1/2 Alpha) and Terminal Half-life (t1/2 Beta) of I 131 TST for the Antibody Predose Levels of 0 mg, 95 mg, and 475 mg
95 mg, terminal t1/2 beta, n=35
|
72.6 hours (hr)
Standard Deviation 41.3
|
—
|
|
Half-life: Initial Half-life (t1/2 Alpha) and Terminal Half-life (t1/2 Beta) of I 131 TST for the Antibody Predose Levels of 0 mg, 95 mg, and 475 mg
475 mg, terminal t1/2 beta, n=102
|
84.5 hours (hr)
Standard Deviation 52.9
|
—
|
SECONDARY outcome
Timeframe: Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion.Population: ITT Exposed Population. The sample size ("n") in the category titles is the number of infusions (dosing occasions) with parameter results.
Clearance is defined as the volume of blood from which drug is removed per unit time and is a measure of the rate at which drug is removed from the body after the dose.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=161 infusions
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Clearance (CL) of I 131 TST for the Indicated Antibody Predose Levels
0 mg, n=24
|
205 Milliliters per hour (mL/hr)
Standard Deviation 229
|
—
|
|
Clearance (CL) of I 131 TST for the Indicated Antibody Predose Levels
95 mg, n=35
|
99.4 Milliliters per hour (mL/hr)
Standard Deviation 78.4
|
—
|
|
Clearance (CL) of I 131 TST for the Indicated Antibody Predose Levels
475 mg, n=102
|
72.1 Milliliters per hour (mL/hr)
Standard Deviation 39.0
|
—
|
SECONDARY outcome
Timeframe: Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion.Population: ITT Exposed Population. The sample size ("n") in the category titles is the number of infusions (dosing occasions) with parameter results.
Area under the concentration-time curve from the end of the infusion extrapolated to infinite time. AUC measures how much drug is in the system over time after infusion. ID, injected dose.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=161 infusions
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Area Under the Concentration Time Curve (AUC) of I 131 TST for the Indicated Antibody Predose Levels
0 mg, n=24
|
0.838 %ID * hours per milliliter (%ID.hr/mL)
Standard Deviation 0.453
|
—
|
|
Area Under the Concentration Time Curve (AUC) of I 131 TST for the Indicated Antibody Predose Levels
95 mg, n=35
|
1.42 %ID * hours per milliliter (%ID.hr/mL)
Standard Deviation 0.73
|
—
|
|
Area Under the Concentration Time Curve (AUC) of I 131 TST for the Indicated Antibody Predose Levels
475 mg, n=102
|
1.68 %ID * hours per milliliter (%ID.hr/mL)
Standard Deviation 0.74
|
—
|
SECONDARY outcome
Timeframe: Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusionPopulation: ITT Exposed Population. The sample size ("n") in the category titles is the number of infusions (dosing occasions) with parameter results.
Cmax is defined as the maximum observed concentration of the drug in blood.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=161 infusions
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Maximum Blood Concentration (Cmax) of I 131 TST for the Indicated Antibody Predose Levels
0 mg, n=24
|
0.0164 % Injected Dose per milliliter (%ID/mL)
Standard Deviation 0.0046
|
—
|
|
Maximum Blood Concentration (Cmax) of I 131 TST for the Indicated Antibody Predose Levels
95 mg, n=35
|
0.0190 % Injected Dose per milliliter (%ID/mL)
Standard Deviation 0.0042
|
—
|
|
Maximum Blood Concentration (Cmax) of I 131 TST for the Indicated Antibody Predose Levels
475 mg, n=102
|
0.0194 % Injected Dose per milliliter (%ID/mL)
Standard Deviation 0.0041
|
—
|
SECONDARY outcome
Timeframe: Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusionPopulation: ITT Exposed Population. The sample size ("n") in the category titles is the number of infusions (dosing occasions) with parameter results.
Vss is defined as the volume of distribution of the drug at steady state.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=161 infusions
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Volume of Distribution at Steady State (Vss) of I 131 TST for the Indicated Antibody Predose Levels
0 mg, n=24
|
13.0 liters
Standard Deviation 12.3
|
—
|
|
Volume of Distribution at Steady State (Vss) of I 131 TST for the Indicated Antibody Predose Levels
95 mg, n=35
|
7.74 liters
Standard Deviation 4.25
|
—
|
|
Volume of Distribution at Steady State (Vss) of I 131 TST for the Indicated Antibody Predose Levels
475 mg, n=102
|
7.08 liters
Standard Deviation 2.16
|
—
|
SECONDARY outcome
Timeframe: Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.Population: ITT Exposed Population. Only those participants evaluable for HAMA were analyzed.
Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants in this study were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I 131 tositumomab. A positive HAMA value indicates that the participant developed human anti-mouse antibodies above the HAMA assay threshold, and a negative HAMA value indicates either the absence or a below threshold level of human anti-mouse antibodies.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=58 Participants
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
n=4 Participants
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Number of Participants Who Developed Human Anti-mouse Antibodies (HAMA Postivitiy) After Receiving Tositumomab
Positive
|
9 participants
|
2 participants
|
|
Number of Participants Who Developed Human Anti-mouse Antibodies (HAMA Postivitiy) After Receiving Tositumomab
Negative
|
49 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.Population: ITT Exposed Population. Participants who converted to HAMA positivity were analyzed.
Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants in this study were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I 131 tositumomab. A positive HAMA value indicates that the participant developed human anti-mouse antibodies above the HAMA assay threshold, and a negative HAMA value indicates either the absence or a below threshold level of human anti-mouse antibodies.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=9 Participants
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
n=2 Participants
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Time to HAMA Positivity From the First Dosimetric Dose (Time From Baseline [Dosimetric Dose] to the First Reported Presence of HAMA)
|
15.0 days
Interval 12.0 to 194.0
|
1271 days
Interval 19.0 to 2523.0
|
SECONDARY outcome
Timeframe: Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.Population: ITT Exposed Population
An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=59 Participants
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
n=14 Participants
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Number of Participants With the Indicated Type of Infection
Staphylococcal Sepsis; n=24, 2
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Type of Infection
Any Infection; n=59, 14
|
24 participants
|
2 participants
|
|
Number of Participants With the Indicated Type of Infection
No Infection; n=59, 14
|
35 participants
|
12 participants
|
|
Number of Participants With the Indicated Type of Infection
Upper Respiratory Tract Infection; n=24, 2
|
6 participants
|
1 participants
|
|
Number of Participants With the Indicated Type of Infection
Urinary Tract Infection; n=24, 2
|
5 participants
|
1 participants
|
|
Number of Participants With the Indicated Type of Infection
Nasopharyngitis; n=24, 2
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated Type of Infection
Respiratory Tract Infection; n=24, 2
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated Type of Infection
Sinusitis; n=24, 2
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated Type of Infection
Device Related Infection; n=24, 2
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Type of Infection
Eye Infection; n=24, 2
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Type of Infection
Hemophilus Infection; n=24, 2
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Type of Infection
Herpes Virus Infection; n=24, 2
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Type of Infection
Herpes Zoster; n=24, 2
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Type of Infection
Infusion Site Cellulitis; n=24, 2
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Type of Infection
Pneumonia; n=24, 2
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Type of Infection
Pneumonia Streptococcal; n=24, 2
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Type of Infection
Postoperative Wound Infection; n=24, 2
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Type of Infection
Vestibular Neuronitis; n=24, 2
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Type of Infection
Viral Infection; n=24, 2
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Type of Infection
Viral Upper Respiratory Tract Infection; n=24, 2
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Type of Infection
Sepsis; n=24, 2
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.Population: ITT Exposed Population. Only those participants for which nadir could be calculated were analyzed. Some participants did not have post-baseline data available.
Nadir is defined as the lowest laboratory value recorded following the administration of the study medication.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=57 Participants
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
n=14 Participants
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Time to Nadir for the Indicated Hematologic Laboratory Parameters
Time to nadir, ANC, n=40, 12
|
44.5 days
Interval 8.0 to 97.0
|
44.5 days
Interval 28.0 to 111.0
|
|
Time to Nadir for the Indicated Hematologic Laboratory Parameters
Time to nadir, hemoglobin, n=57, 14
|
34.0 days
Interval 2.0 to 119.0
|
49.5 days
Interval 5.0 to 111.0
|
|
Time to Nadir for the Indicated Hematologic Laboratory Parameters
Time to nadir, platelets, n=57, 14
|
34.0 days
Interval 2.0 to 97.0
|
41.0 days
Interval 23.0 to 104.0
|
|
Time to Nadir for the Indicated Hematologic Laboratory Parameters
Time to nadir, WBC count, n=57, 14
|
41.0 days
Interval 2.0 to 119.0
|
48.0 days
Interval 5.0 to 100.0
|
SECONDARY outcome
Timeframe: Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.Population: ITT Exposed Population. Only those participants for which nadir could be calculated were analyzed. Some participants did not have post-baseline data available.
Time to recovery to baseline is the time required for recovery from nadir values to baseline values.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=46 Participants
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
n=4 Participants
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Time to Recovery to Baseline for the Indicated Hematologic Laboratory Parameters
Time to recovery to baseline, ANC, n=23, 2
|
79.0 days
Interval 57.0 to 108.0
|
74.0 days
Interval 44.0 to 74.0
|
|
Time to Recovery to Baseline for the Indicated Hematologic Laboratory Parameters
Time to recovery to baseline, hemoglobin, n=46, 4
|
42.0 days
Interval 34.0 to 55.0
|
38.5 days
Interval 6.0 to
The SAS procedure was not able to calculate the upper limit of the confidence interval.
|
|
Time to Recovery to Baseline for the Indicated Hematologic Laboratory Parameters
Time to recovery to baseline, platelets, n=45, 4
|
57.0 days
Interval 48.0 to 76.0
|
39.0 days
Interval 26.0 to 39.0
|
|
Time to Recovery to Baseline for the Indicated Hematologic Laboratory Parameters
Time to recovery to baseline, WBC count, n=46, 3
|
69.0 days
Interval 49.0 to 91.0
|
77.0 days
Interval 56.0 to 77.0
|
SECONDARY outcome
Timeframe: Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.Population: ITT Exposed Population. Only those participants for which nadir could be calculated were analyzed. Some participants did not have post-baseline data available.
Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of WBC that fights against infection. Platelets and WBCs are types of blood cells.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=57 Participants
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
n=14 Participants
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Nadir Values for the Hematologic Parameters ANC, Platelets, and WBC Count
ANC, n=40, 12
|
1.0 1000 cells/millimeters cubed (mm^3)
Interval 0.0 to 5.0
|
1.3 1000 cells/millimeters cubed (mm^3)
Interval 0.0 to 5.0
|
|
Nadir Values for the Hematologic Parameters ANC, Platelets, and WBC Count
Platelets, n=57, 14
|
74.0 1000 cells/millimeters cubed (mm^3)
Interval 2.0 to 292.0
|
79.5 1000 cells/millimeters cubed (mm^3)
Interval 3.0 to 224.0
|
|
Nadir Values for the Hematologic Parameters ANC, Platelets, and WBC Count
WBC count, n=57, 14
|
2.7 1000 cells/millimeters cubed (mm^3)
Interval 0.0 to 9.0
|
3.3 1000 cells/millimeters cubed (mm^3)
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.Population: ITT Exposed Population
Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.
Outcome measures
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=59 Participants
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
n=14 Participants
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu
|
|---|---|---|
|
Nadir Values for Hemoglobin, a Hematologic Parameter
|
10.9 G/dL
Interval 6.0 to 14.0
|
11.7 G/dL
Interval 5.0 to 14.0
|
Adverse Events
TST and Iodine I 131 TST: Initial Treatment
Serious events: 17 serious events
Other events: 55 other events
Deaths: 0 deaths
TST and Iodine I 131 TST: Retreatment
Serious events: 7 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=59 participants at risk
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
n=14 participants at risk
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
8.5%
5/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
35.7%
5/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukemia
|
5.1%
3/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin
|
0.00%
0/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal Cancer
|
0.00%
0/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid Tumour Pulmonary
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hemangioma
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or Oral Cavity Cancer
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Immune system disorders
Serum Sickness
|
3.4%
2/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Immune system disorders
Anaphylactic Reaction
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Immune system disorders
Anaphylactoid Reaction
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Blood and lymphatic system disorders
Anemia
|
5.1%
3/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.1%
3/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.4%
2/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Infections and infestations
Hemophilus Infection
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Infections and infestations
Sepsis
|
0.00%
0/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Infections and infestations
Pneumonia Streptococcal
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Infections and infestations
Staphylococcal Sepsis
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
General disorders
Pyrexia
|
3.4%
2/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
General disorders
Fatigue
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Skin and subcutaneous tissue disorders
Necrotising Panniculitis
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
Other adverse events
| Measure |
TST and Iodine I 131 TST: Initial Treatment
n=59 participants at risk
Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
TST and Iodine I 131 TST: Retreatment
n=14 participants at risk
After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
|---|---|---|
|
General disorders
Pyrexia
|
52.5%
31/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
35.7%
5/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
General disorders
Fatigue
|
33.9%
20/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
21.4%
3/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
General disorders
Chills
|
28.8%
17/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
28.6%
4/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
General disorders
Pain
|
3.4%
2/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
General disorders
Asthenia
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
General disorders
Axillary Pain
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
General disorders
Catheter Site Rash
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
General disorders
Chest Pain
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
General disorders
Ill-Defined Disorder
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
General disorders
Infusion Site Inflammation
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
General disorders
Infusion Site Phlebitis
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
General disorders
Medical Device Complication
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
General disorders
Mucous Membrane Disorder
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
General disorders
Oedema Peripheral
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Gastrointestinal disorders
Nausea
|
33.9%
20/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
50.0%
7/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Gastrointestinal disorders
Vomiting
|
13.6%
8/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Gastrointestinal disorders
Diarrhea
|
10.2%
6/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Gastrointestinal disorders
Constipation
|
5.1%
3/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Gastrointestinal disorders
Gastritis
|
5.1%
3/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
3.4%
2/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.4%
2/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Gastrointestinal disorders
Diarrhea Hemorrhagic
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Gastrointestinal disorders
Fecal Incontinence
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Investigations
White Blood Cells < 2000 cells/cm^3
|
37.3%
22/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
28.6%
4/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Investigations
Absolute Neutrophil Count <1000 cells/cm^3
|
35.6%
21/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
42.9%
6/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Investigations
Platelets <50000 cells/cm^3
|
30.5%
18/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
21.4%
3/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Investigations
Hemoglobin <8.0 g/dL
|
18.6%
11/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
14.3%
2/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.2%
6/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Infections and infestations
Urinary Tract Infection
|
8.5%
5/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
2/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Infections and infestations
Respiratory Tract Infection
|
3.4%
2/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Infections and infestations
Sinusitis
|
3.4%
2/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Infections and infestations
Device related infection
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Infections and infestations
Eye infection
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Infections and infestations
Herpes Virus Infection
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Infections and infestations
Herpes Zoster
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Infections and infestations
Infusion Site Cellulitis
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Infections and infestations
Pneumonia
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Infections and infestations
Postoperative Wound Infection
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Infections and infestations
Vestibular Neuronitis
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Infections and infestations
Viral infection
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
13.6%
8/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.2%
6/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.5%
5/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.5%
5/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
14.3%
2/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.4%
2/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.9%
10/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
14.3%
2/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
14.3%
2/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.9%
7/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
6.8%
4/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
3.4%
2/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
3.4%
2/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Nervous system disorders
Headache
|
10.2%
6/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
21.4%
3/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Nervous system disorders
Dizziness
|
8.5%
5/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Nervous system disorders
Hypoaesthesia
|
3.4%
2/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Nervous system disorders
Sciatica
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
8.5%
5/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
3/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Ulcer
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Endocrine disorders
Hypothyroidism
|
11.9%
7/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
21.4%
3/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.1%
3/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.4%
2/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.4%
2/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Eye disorders
Conjunctivitis
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Eye disorders
Diplopia
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Eye disorders
Eye Irritation
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Eye disorders
Photophobia
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
6.8%
4/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Renal and urinary disorders
Oliguria
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Renal and urinary disorders
Ureteric Obstruction
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Renal and urinary disorders
Urinary Incontinence
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Renal and urinary disorders
Urinary Retention
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Renal and urinary disorders
Bladder Pain
|
0.00%
0/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Vascular disorders
Flushing
|
3.4%
2/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Vascular disorders
Hypotension
|
3.4%
2/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Immune system disorders
Serum Sickness
|
3.4%
2/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Investigations
Weight Decreased
|
3.4%
2/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Psychiatric disorders
Disorientation
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Psychiatric disorders
Nightmare
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Cardiac disorders
Sinus Tachycardia
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Ear and labyrinth disorders
Vertigo
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Injury, poisoning and procedural complications
Laceration
|
1.7%
1/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
0.00%
0/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Ear and labyrinth disorders
Ear Discomfort
|
0.00%
0/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Injury, poisoning and procedural complications
Ear Injury
|
0.00%
0/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/59 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
7.1%
1/14 • Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER