Trial Outcomes & Findings for Dosimetry/Validation Study of 131Iodine-Anti B1 (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas That Have Transformed to Higher Grade Histologies (NCT NCT01224821)
NCT ID: NCT01224821
Last Updated: 2016-12-12
Results Overview
The dosimetry methods were validated for seven different clinical research sites.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Day 1 within one hour of infusion (I) and prior to urination (U); Days 2, 3, and 4 after dosimetric dose (DD) I, following U; Days 6 and 7 after DD I, following U
Results posted on
2016-12-12
Participant Flow
Participants (par.) received radioimmunotherapy of tositumomab (TST) and Iodine I 131 TST in 2 phases (Ph.): Ph. 1, dosimetric dose; Ph. 2, therapeutic dose. Par. were evaluated until disease progression, they died, or they were on study for 2 years. Par. completing 2 years of study could enter a long-term follow-up study (BEX104526; NCT00240591).
Participant milestones
| Measure |
TST and Iodine I 131 TST
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
|
|---|---|
|
Dosimetric and Therapeutic Treatment
STARTED
|
47
|
|
Dosimetric and Therapeutic Treatment
COMPLETED
|
1
|
|
Dosimetric and Therapeutic Treatment
NOT COMPLETED
|
46
|
|
Long-Term Follow-Up
STARTED
|
11
|
|
Long-Term Follow-Up
COMPLETED
|
0
|
|
Long-Term Follow-Up
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
TST and Iodine I 131 TST
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
|
|---|---|
|
Dosimetric and Therapeutic Treatment
Adverse Event
|
1
|
|
Dosimetric and Therapeutic Treatment
Progressive Disease
|
38
|
|
Dosimetric and Therapeutic Treatment
Continued Follow-up in Study BEX104526
|
3
|
|
Dosimetric and Therapeutic Treatment
Lost to Follow-up
|
2
|
|
Dosimetric and Therapeutic Treatment
Withdrawal by Subject
|
1
|
|
Dosimetric and Therapeutic Treatment
Started Other Treatment
|
1
|
|
Long-Term Follow-Up
Death
|
2
|
|
Long-Term Follow-Up
Completion of 10 Year Follow-up
|
9
|
Baseline Characteristics
Dosimetry/Validation Study of 131Iodine-Anti B1 (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas That Have Transformed to Higher Grade Histologies
Baseline characteristics by cohort
| Measure |
TST and Iodine I 131 TST
n=47 Participants
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
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|---|---|
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Age, Continuous
|
50.6 Years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Gender
Female
|
22 Participants
n=5 Participants
|
|
Gender
Male
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
45 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 within one hour of infusion (I) and prior to urination (U); Days 2, 3, and 4 after dosimetric dose (DD) I, following U; Days 6 and 7 after DD I, following UPopulation: Intent-to-Treat (ITT) Exposed Population: all participants who enrolled in the study and received at least one dose of study drug. One participant did not receive the therapeutic dose.
The dosimetry methods were validated for seven different clinical research sites.
Outcome measures
| Measure |
TST and Iodine I 131 TST
n=46 Participants
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
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|---|---|
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Number of Participants Who Received the Therapeutic Dose at the Seven Clinical Research Sites
Clinical site 005
|
8 participants
|
|
Number of Participants Who Received the Therapeutic Dose at the Seven Clinical Research Sites
Clinical site 003
|
7 participants
|
|
Number of Participants Who Received the Therapeutic Dose at the Seven Clinical Research Sites
Clinical site 004
|
8 participants
|
|
Number of Participants Who Received the Therapeutic Dose at the Seven Clinical Research Sites
Clinical site 006
|
5 participants
|
|
Number of Participants Who Received the Therapeutic Dose at the Seven Clinical Research Sites
Clinical site 007
|
6 participants
|
|
Number of Participants Who Received the Therapeutic Dose at the Seven Clinical Research Sites
Clinical site 008
|
6 participants
|
|
Number of Participants Who Received the Therapeutic Dose at the Seven Clinical Research Sites
Clinical site 009
|
6 participants
|
SECONDARY outcome
Timeframe: Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 monthsPopulation: ITT Exposed Population
Based on their platelet count and body weight. Participants received different TDs of TST. For obese participants (weighing more than 137% of their calculated lean body weight), the calculation to determine the administered activity (mCi) was performed using the maximum effective mass (i.e., the minimum of the participant's mass and 137% of their calculated lean body weight). The administered activity (mCi) for participants with a Baseline platelet count of 100001-149999 cells/millimeter cubed (mm\^3) was reduced to a 65 cGy total body dose, after any adjustment for obesity.
Outcome measures
| Measure |
TST and Iodine I 131 TST
n=47 Participants
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
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|---|---|
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Number of Participants With the Indicated Therapeutic Doses (TD) (Total Body Dose)
0 cGy
|
1 participants
|
|
Number of Participants With the Indicated Therapeutic Doses (TD) (Total Body Dose)
53 cGy
|
1 participants
|
|
Number of Participants With the Indicated Therapeutic Doses (TD) (Total Body Dose)
65 cGy
|
9 participants
|
|
Number of Participants With the Indicated Therapeutic Doses (TD) (Total Body Dose)
75 cGy
|
36 participants
|
SECONDARY outcome
Timeframe: Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 monthsPopulation: 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
n=46 Participants
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
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|---|---|
|
Number of Participants (Par.) With Response (CR, CCR, or PR), as Assessed by the Investigator
|
27 participants
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SECONDARY outcome
Timeframe: Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 monthsPopulation: 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
n=39 Participants
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
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|---|---|
|
Number of Participants With Confirmed Response (CR, CCR, or PR), as Assessed by the Investigator
|
23 participants
|
SECONDARY outcome
Timeframe: Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 monthsPopulation: ITT Exposed Population. Only those participants evaluable for response were analyzed.
The total number of participants with CR and CCR was reported. CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Clinical Complete Response: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present.
Outcome measures
| Measure |
TST and Iodine I 131 TST
n=46 Participants
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
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|---|---|
|
Number of Participants With CR and CCR, as Assessed by the Investigator
|
15 participants
|
SECONDARY outcome
Timeframe: Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 monthsPopulation: ITT Exposed Population. Only those participants evaluable for confirmed CR and CCR were analyzed.
The total number of participants with CR and CCR was reported. Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart. CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Clinical Complete Response: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present.
Outcome measures
| Measure |
TST and Iodine I 131 TST
n=39 Participants
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
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|---|---|
|
Number of Participants With Confirmed CR and CCR, as Assessed by the Investigator
|
14 participants
|
SECONDARY outcome
Timeframe: Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 monthsPopulation: ITT Exposed Population. Only those participants with a confirmed response were analyzed.
Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a \>=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be \>2 cm in diameter by radiographic evaluation or \>1 cm in diameter by physical examination.
Outcome measures
| Measure |
TST and Iodine I 131 TST
n=23 Participants
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
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|---|---|
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Duration of Response for All Confirmed Responders (CR, CCR, or PR), as Assessed by the Investigator
|
14.3 months
Interval 7.4 to 31.2
|
SECONDARY outcome
Timeframe: Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 monthsPopulation: ITT Exposed Population. Only those participants with a confirmed response were analyzed.
Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a \>=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be \>2 cm in diameter by radiographic evaluation or \>1 cm in diameter by physical examination.
Outcome measures
| Measure |
TST and Iodine I 131 TST
n=27 Participants
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
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|---|---|
|
Duration of Response for All Unconfirmed Responders (CR, CCR, or PR), as Assessed by the Investigator
|
9.9 months
Interval 4.2 to 31.2
|
SECONDARY outcome
Timeframe: Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 monthsPopulation: ITT Exposed Population. Only those participants with a confirmed CR were analyzed.
Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a \>=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be \>2 cm in diameter by radiographic evaluation or \>1 cm in diameter by physical examination.
Outcome measures
| Measure |
TST and Iodine I 131 TST
n=11 Participants
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
|
|---|---|
|
Duration of Response for All Confirmed Complete Responders, as Assessed by the Investigator
|
31.2 months
Interval 13.6 to 95.9
|
SECONDARY outcome
Timeframe: Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 monthsPopulation: ITT Exposed Population. Only those participants with a confirmed CR were analyzed.
Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a \>=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be \>2 cm in diameter by radiographic evaluation or \>1 cm in diameter by physical examination.
Outcome measures
| Measure |
TST and Iodine I 131 TST
n=13 Participants
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
|
|---|---|
|
Duration of Response for All Unconfirmed Complete Responders, as Assessed by the Investigator
|
31.2 months
Interval 13.6 to 95.7
|
SECONDARY outcome
Timeframe: Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 monthsPopulation: ITT Exposed Population. Only those participants with a confirmed CCR were analyzed.
Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a \>=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be \>2 cm in diameter by radiographic evaluation or \>1 cm in diameter by physical examination.
Outcome measures
| Measure |
TST and Iodine I 131 TST
n=2 Participants
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
|
|---|---|
|
Duration of Response for All Confirmed Clinical Complete Responders, as Assessed by the Investigator
|
17.2 months
Interval 14.6 to 19.9
|
SECONDARY outcome
Timeframe: Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 monthsPopulation: ITT Exposed Population. Only those participants with a confirmed CCR were analyzed.
Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a \>=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be \>2 cm in diameter by radiographic evaluation or \>1 cm in diameter by physical examination.
Outcome measures
| Measure |
TST and Iodine I 131 TST
n=2 Participants
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
|
|---|---|
|
Duration of Response for All Unconfirmed Clinical Complete Responders, as Assessed by the Investigator
|
17.2 months
Interval 14.6 to 19.9
|
SECONDARY outcome
Timeframe: Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 monthsPopulation: ITT Exposed Population
Time to treatment failure is defined as the length of time from the date of enrollment to the first incidence of treatment withdrawal, study removal, progression, and/or alternative therapy for the participant's lymphoma, or death.
Outcome measures
| Measure |
TST and Iodine I 131 TST
n=47 Participants
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
|
|---|---|
|
Median Time to Treatment Failure for All Participants
|
5 months
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 monthsPopulation: ITT Exposed Population. Only those participants who died during the study were analyzed.
Overall survival is defined as the time from the treatment start date to the date of death from any cause. Time to death is the time from the dosimetric dose to the date of death.
Outcome measures
| Measure |
TST and Iodine I 131 TST
n=34 Participants
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
|
|---|---|
|
Overall Survival
|
35.3 months
Interval 24.7 to 83.4
|
SECONDARY outcome
Timeframe: Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 monthsPopulation: ITT Exposed Population. Only participants classified as responders with disease progression or those who died were analyzed.
Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.
Outcome measures
| Measure |
TST and Iodine I 131 TST
n=45 Participants
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
|
|---|---|
|
Time to Disease Progression or Death for Responders, as Assessed by the Investigator
|
5.3 months
Interval 3.2 to 6.6
|
SECONDARY outcome
Timeframe: Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 monthsPopulation: ITT Exposed Population. Only participants with disease progression or those who died were analyzed.
Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.
Outcome measures
| Measure |
TST and Iodine I 131 TST
n=47 Participants
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
|
|---|---|
|
Time to Disease Progression or Death for All Participants, as Assessed by the Investigator
|
5 months
Interval 3.0 to 7.0
|
Adverse Events
TST and Iodine I 131 TST
Serious events: 23 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TST and Iodine I 131 TST
n=47 participants at risk
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
8.5%
4/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukemia
|
6.4%
3/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
4.3%
2/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
2.1%
1/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma
|
2.1%
1/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer in situ
|
2.1%
1/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or Oral Cavity Carcinoma
|
2.1%
1/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Squamous Cell Carcinoma Stage Unspecified
|
2.1%
1/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Cancer
|
2.1%
1/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue Neoplasm Malignant Stage Unspecified
|
2.1%
1/47
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.4%
3/47
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.3%
2/47
|
|
Blood and lymphatic system disorders
Anemia
|
2.1%
1/47
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
2.1%
1/47
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.1%
1/47
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.1%
1/47
|
|
Gastrointestinal disorders
Abdominal Strangulated Hernia
|
2.1%
1/47
|
|
Gastrointestinal disorders
Anal Fissure
|
2.1%
1/47
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
2.1%
1/47
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
2.1%
1/47
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/47
|
|
Infections and infestations
Bacteremia
|
2.1%
1/47
|
|
Infections and infestations
Device Related Infection
|
2.1%
1/47
|
|
Infections and infestations
Device Related Sepsis
|
2.1%
1/47
|
|
Infections and infestations
Herpes Zoster
|
2.1%
1/47
|
|
Infections and infestations
Pneumococcal Sepsis
|
2.1%
1/47
|
|
Infections and infestations
Staphylococcal Sepsis
|
2.1%
1/47
|
|
Infections and infestations
Urinary Tract Infection Enterococcal
|
2.1%
1/47
|
|
General disorders
Pyrexia
|
4.3%
2/47
|
|
General disorders
Asthenia
|
2.1%
1/47
|
|
General disorders
Chills
|
2.1%
1/47
|
|
General disorders
Multi-Organ Failure
|
2.1%
1/47
|
|
Vascular disorders
Hypotension
|
6.4%
3/47
|
|
Vascular disorders
Orthostatic Hypotension
|
2.1%
1/47
|
|
Immune system disorders
Serum Sickness
|
2.1%
1/47
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
1/47
|
|
Nervous system disorders
Syncope
|
2.1%
1/47
|
|
Renal and urinary disorders
Oliguria
|
2.1%
1/47
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.1%
1/47
|
|
Skin and subcutaneous tissue disorders
Erythema Nodosum
|
2.1%
1/47
|
Other adverse events
| Measure |
TST and Iodine I 131 TST
n=47 participants at risk
Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
|
|---|---|
|
General disorders
Fatigue
|
40.4%
19/47
|
|
General disorders
Pyrexia
|
34.0%
16/47
|
|
General disorders
Edema Peripheral
|
12.8%
6/47
|
|
General disorders
Chills
|
10.6%
5/47
|
|
General disorders
Local Swelling
|
4.3%
2/47
|
|
General disorders
Mucous Membrane Disorder
|
4.3%
2/47
|
|
General disorders
Asthenia
|
2.1%
1/47
|
|
General disorders
Catheter Site Erythema
|
2.1%
1/47
|
|
General disorders
Catheter Site Pain
|
2.1%
1/47
|
|
General disorders
Chest Discomfort
|
2.1%
1/47
|
|
General disorders
Extravasation
|
2.1%
1/47
|
|
General disorders
Feeling Abnormal
|
2.1%
1/47
|
|
General disorders
Gait Disturbance
|
2.1%
1/47
|
|
General disorders
Hunger
|
2.1%
1/47
|
|
General disorders
Infusion Site Extravasation
|
2.1%
1/47
|
|
General disorders
Localized Edema
|
2.1%
1/47
|
|
General disorders
Malaise
|
2.1%
1/47
|
|
General disorders
Multi-Organ Failure
|
2.1%
1/47
|
|
Investigations
Absolute Neutrophill Count (ANC) <1000 cells/cubic millim(cm
|
61.7%
29/47
|
|
Investigations
Platelets < 50,000 cells/cmm
|
57.4%
27/47
|
|
Investigations
WBC (White Blood Cells) < 2,000 cells/cmm
|
57.4%
27/47
|
|
Investigations
Hemoglobin < 8.0 grams/deciliter (g/dL)
|
23.4%
11/47
|
|
Gastrointestinal disorders
Nausea
|
44.7%
21/47
|
|
Gastrointestinal disorders
Vomiting
|
25.5%
12/47
|
|
Gastrointestinal disorders
Abdominal Pain
|
12.8%
6/47
|
|
Gastrointestinal disorders
Diarrhea
|
8.5%
4/47
|
|
Gastrointestinal disorders
Stomatitis
|
4.3%
2/47
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
2.1%
1/47
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.1%
1/47
|
|
Gastrointestinal disorders
Abdominal Strangulated Hernia
|
2.1%
1/47
|
|
Gastrointestinal disorders
Abdominal Tenderness
|
2.1%
1/47
|
|
Gastrointestinal disorders
Anal Fissure
|
2.1%
1/47
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
2.1%
1/47
|
|
Gastrointestinal disorders
Constipation
|
2.1%
1/47
|
|
Gastrointestinal disorders
Dry Mouth
|
2.1%
1/47
|
|
Gastrointestinal disorders
Dyspepsia
|
2.1%
1/47
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
2.1%
1/47
|
|
Gastrointestinal disorders
Gastroesophageal Reflux disease
|
2.1%
1/47
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.1%
1/47
|
|
Gastrointestinal disorders
Proctalgia
|
2.1%
1/47
|
|
Gastrointestinal disorders
Rectal Fissure
|
2.1%
1/47
|
|
Gastrointestinal disorders
Retching
|
2.1%
1/47
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.6%
5/47
|
|
Infections and infestations
Herpes Zoster
|
8.5%
4/47
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
3/47
|
|
Infections and infestations
Sinusitis
|
6.4%
3/47
|
|
Infections and infestations
Pharyngitis
|
4.3%
2/47
|
|
Infections and infestations
Urinary Tract Infection
|
4.3%
2/47
|
|
Infections and infestations
Viral Infection
|
4.3%
2/47
|
|
Infections and infestations
Bacteremia
|
2.1%
1/47
|
|
Infections and infestations
Bacterial Infection
|
2.1%
1/47
|
|
Infections and infestations
Device Related Infection
|
2.1%
1/47
|
|
Infections and infestations
Device Related Sepsis
|
2.1%
1/47
|
|
Infections and infestations
Herpes Virus Infection
|
2.1%
1/47
|
|
Infections and infestations
Infusion Site Cellulitis
|
2.1%
1/47
|
|
Infections and infestations
Labyrinthitis
|
2.1%
1/47
|
|
Infections and infestations
Oral Herpes
|
2.1%
1/47
|
|
Infections and infestations
Pneumococcal Sepsis
|
2.1%
1/47
|
|
Infections and infestations
Pseudomonas Infection
|
2.1%
1/47
|
|
Infections and infestations
Respiratory Tract Infection
|
2.1%
1/47
|
|
Infections and infestations
Staphylococcal Sepsis
|
2.1%
1/47
|
|
Infections and infestations
Urinary Tract Infection Enterococcal
|
2.1%
1/47
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
2.1%
1/47
|
|
Nervous system disorders
Headache
|
21.3%
10/47
|
|
Nervous system disorders
Dizziness
|
4.3%
2/47
|
|
Nervous system disorders
Neuropathy Peripheral
|
4.3%
2/47
|
|
Nervous system disorders
Presyncope
|
4.3%
2/47
|
|
Nervous system disorders
Somnolence
|
4.3%
2/47
|
|
Nervous system disorders
Syncope
|
4.3%
2/47
|
|
Nervous system disorders
Ageusia
|
2.1%
1/47
|
|
Nervous system disorders
Ataxia
|
2.1%
1/47
|
|
Nervous system disorders
Lethargy
|
2.1%
1/47
|
|
Nervous system disorders
Migraine
|
2.1%
1/47
|
|
Nervous system disorders
Post Herpetic Neuralgia
|
2.1%
1/47
|
|
Nervous system disorders
Sensory Disturbance
|
2.1%
1/47
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.6%
5/47
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.4%
3/47
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
6.4%
3/47
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
6.4%
3/47
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.3%
2/47
|
|
Respiratory, thoracic and mediastinal disorders
Choking Sensation
|
2.1%
1/47
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
2.1%
1/47
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
2.1%
1/47
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
2.1%
1/47
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Blistering
|
2.1%
1/47
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Erythema
|
2.1%
1/47
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
2.1%
1/47
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.1%
1/47
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.8%
6/47
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.5%
4/47
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.4%
3/47
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
2/47
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
4.3%
2/47
|
|
Skin and subcutaneous tissue disorders
Blood Blister
|
2.1%
1/47
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.1%
1/47
|
|
Skin and subcutaneous tissue disorders
Erythema Nodosum
|
2.1%
1/47
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
2.1%
1/47
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
2.1%
1/47
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
2.1%
1/47
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
2.1%
1/47
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
23.4%
11/47
|
|
Blood and lymphatic system disorders
Anemia
|
21.3%
10/47
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.6%
5/47
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.4%
3/47
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.3%
2/47
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
2.1%
1/47
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.1%
1/47
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.9%
7/47
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.5%
4/47
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.5%
4/47
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.1%
1/47
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
2.1%
1/47
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
2.1%
1/47
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
2.1%
1/47
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
2.1%
1/47
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
2.1%
1/47
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.1%
1/47
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
2.1%
1/47
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
2.1%
1/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
8.5%
4/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukemia
|
6.4%
3/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
4.3%
2/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
2.1%
1/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma
|
2.1%
1/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer in situ
|
2.1%
1/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or Oral Cavity Cancer
|
2.1%
1/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Squamous Cell Carcinoma Stage Unspecified
|
2.1%
1/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Cancer
|
2.1%
1/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue Neoplasm Malignant Stage Unspecified
|
2.1%
1/47
|
|
Endocrine disorders
Hypothyroidism
|
19.1%
9/47
|
|
Vascular disorders
Hypotension
|
8.5%
4/47
|
|
Vascular disorders
Flushing
|
4.3%
2/47
|
|
Vascular disorders
Orthostatic Hypotension
|
2.1%
1/47
|
|
Vascular disorders
Pallor
|
2.1%
1/47
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
10.6%
5/47
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
2/47
|
|
Injury, poisoning and procedural complications
Contusion
|
2.1%
1/47
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.1%
1/47
|
|
Injury, poisoning and procedural complications
Laceration
|
2.1%
1/47
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
2.1%
1/47
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
2.1%
1/47
|
|
Ear and labyrinth disorders
Tinnitus
|
4.3%
2/47
|
|
Ear and labyrinth disorders
Ear Discomfort
|
2.1%
1/47
|
|
Immune system disorders
Serum Sickness
|
4.3%
2/47
|
|
Immune system disorders
Anaphylactic Reaction
|
2.1%
1/47
|
|
Investigations
Weight Decreased
|
4.3%
2/47
|
|
Investigations
Blood Thyroid Stimulating Hormone Increased
|
2.1%
1/47
|
|
Renal and urinary disorders
Oliguria
|
2.1%
1/47
|
|
Renal and urinary disorders
Ureteric Obstruction
|
2.1%
1/47
|
|
Renal and urinary disorders
Urinary hesitation
|
2.1%
1/47
|
|
Eye disorders
Conjunctivitis
|
2.1%
1/47
|
|
Eye disorders
Periorbital Edema
|
2.1%
1/47
|
|
Psychiatric disorders
Confusional State
|
2.1%
1/47
|
|
Psychiatric disorders
Insomnia
|
2.1%
1/47
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
2.1%
1/47
|
|
Reproductive system and breast disorders
Vaginal Lesion
|
2.1%
1/47
|
|
Cardiac disorders
Tachycardia
|
2.1%
1/47
|
|
Congenital, familial and genetic disorders
Spinocerebellar Ataxia
|
2.1%
1/47
|
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