Trial Outcomes & Findings for Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody Plus CHOP For Untreated Mantle Cell Lymphoma (NCT NCT00992992)
NCT ID: NCT00992992
Last Updated: 2019-12-04
Results Overview
Participants with response include those with complete response (CR: complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms), complete response unconfirmed (CRu: CR, with one of the following: residual lymph node mass \>1.5 centimeters \[cm\] that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow), or partial response (PR: \>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)
Results posted on
2019-12-04
Participant Flow
Participant milestones
| Measure |
Iodine I-131 Tositumomab + CHOP
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
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|---|---|
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Overall Study
STARTED
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25
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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25
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Reasons for withdrawal
| Measure |
Iodine I-131 Tositumomab + CHOP
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
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Overall Study
Lost to Follow-up
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3
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Overall Study
Death
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16
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Overall Study
GlaxoSmithKline Closed the Study
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2
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Overall Study
Sponsor Closed the Study
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4
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Baseline Characteristics
Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody Plus CHOP For Untreated Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Iodine I-131 Tositumomab + CHOP
n=25 Participants
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
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|---|---|
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Age, Continuous
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64.4 Years
STANDARD_DEVIATION 9.6 • n=99 Participants
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Sex: Female, Male
Female
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2 Participants
n=99 Participants
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Sex: Female, Male
Male
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23 Participants
n=99 Participants
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Race/Ethnicity, Customized
White
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24 participants
n=99 Participants
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Race/Ethnicity, Customized
Hispanic
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1 participants
n=99 Participants
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PRIMARY outcome
Timeframe: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)Population: ITT-Exposed Population: all participants who received any iodine I-131 tositumomab or CHOP treatment. Only those participants evaluable for response (those with at least one response assessment) were analyzed.
Participants with response include those with complete response (CR: complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms), complete response unconfirmed (CRu: CR, with one of the following: residual lymph node mass \>1.5 centimeters \[cm\] that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow), 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 |
Iodine I-131 Tositumomab + CHOP
n=24 Participants
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
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|---|---|
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Number of Participants With the Indicated Unconfirmed Response (Complete Response, Complete Response Unconfirmed, and Partial Response)
CR
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14 Participants
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Number of Participants With the Indicated Unconfirmed Response (Complete Response, Complete Response Unconfirmed, and Partial Response)
CRu
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2 Participants
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Number of Participants With the Indicated Unconfirmed Response (Complete Response, Complete Response Unconfirmed, and Partial Response)
PR
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5 Participants
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SECONDARY outcome
Timeframe: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)Population: ITT-Exposed Population. Only those participants evaluable for response (those with at least one response assessment) were analyzed.
A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart. Participants with a confirmed response include those with complete response (CR: complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms), complete response unconfirmed (CRu: CR, with one of the following: residual lymph node mass \>1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow), or partial response (PR: \>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). The individual rows for confirmed CR, confirmed CRu, and confirmed PR represent confirmation of the same response. For example, a confirmed CR indicates that a CR was followed by another CR at least 4 weeks later.
Outcome measures
| Measure |
Iodine I-131 Tositumomab + CHOP
n=22 Participants
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
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Number of Participants With the Indicated Confirmed Response (Confirmed Complete Response, Complete Response Unconfirmed, and Partial Response)
Confirmed CR
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11 Participants
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Number of Participants With the Indicated Confirmed Response (Confirmed Complete Response, Complete Response Unconfirmed, and Partial Response)
Confirmed CRu
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2 Participants
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Number of Participants With the Indicated Confirmed Response (Confirmed Complete Response, Complete Response Unconfirmed, and Partial Response)
Confirmed PR
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3 Participants
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SECONDARY outcome
Timeframe: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)Population: ITT-Exposed Population. Only those participants (par.) with a confirmed CR, CRu, or PR were analyzed. The number of par. analyzed represents the par. with a confimed CR, CRu, or PR who also had the same response or a better response as confirmation (for example, a par. with an initial CRu and a subsequent CR has been included in the analysis).
Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Complete response unconfirmed (CRu) is defined as CR, with one of the following: residual lymph node mass \>1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow. Partial response (PR) is defined as a \>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. For participants with CR, CRu, or PR, duration of response is defined as the time from the first documented response to the first documented progression.
Outcome measures
| Measure |
Iodine I-131 Tositumomab + CHOP
n=19 Participants
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
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|---|---|
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Duration of Response for All Confirmed Responders (CR + CRu + PR)
|
29.8 Months
Interval 15.8 to
There were too few events of response to calculate an upper limit of the confidence interval.
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SECONDARY outcome
Timeframe: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)Population: ITT-Exposed Population. Only those participants with an unconfirmed response (CR, CRu, or PR) were analyzed for duration of response.
Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Complete response unconfirmed is defined as CR, with one of the following: residual lymph node mass \>1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow. Partial response (PR) is defind as a \>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. Duration of response is defined as the time from the first documented response to the first documented progression.
Outcome measures
| Measure |
Iodine I-131 Tositumomab + CHOP
n=21 Participants
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
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|---|---|
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Duration of Response for All Unconfirmed Responders (CR + CRu + PR)
|
29.8 Months
Interval 15.8 to
There were too few events of response to calculate an upper limit of the confidence interval.
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SECONDARY outcome
Timeframe: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)Population: ITT-Exposed Population. Only those participants with unconfirmed CR were analyzed.
Complete response is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Duration of response is defined as the time from the first documented response to the first documented progression.
Outcome measures
| Measure |
Iodine I-131 Tositumomab + CHOP
n=14 Participants
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
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|---|---|
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Duration of Response for Unconfirmed Complete Responders
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31.8 Months
Interval 15.8 to
There were too few events of response to calculate an upper limit of the confidence interval.
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SECONDARY outcome
Timeframe: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)Population: ITT-Exposed Population. Only those participants with confirmed CR were analyzed.
Complete response is the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart. Duration of response is defined as the time from the first documented response to the first documented progression.
Outcome measures
| Measure |
Iodine I-131 Tositumomab + CHOP
n=11 Participants
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
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|---|---|
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Duration of Response for Confirmed Complete Responders
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54.0 Months
Interval 15.5 to
There were too few events of response to calculate an upper limit of the confidence interval.
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SECONDARY outcome
Timeframe: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)Population: ITT-Exposed Population
Progression-free survival is defined as the time from the start of treatment (i.e., the dosimetric dose) to the first documented disease progression or death. 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 have been greater than 2 centimeters (cm) in diameter by radiographic evaluation or greater than 1 cm in diameter by physical examination.
Outcome measures
| Measure |
Iodine I-131 Tositumomab + CHOP
n=25 Participants
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
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|---|---|
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Progression-free Survival
|
27.6 Months
Interval 17.1 to 39.1
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SECONDARY outcome
Timeframe: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)Population: ITT-Exposed Population
Time to treatment failure is defined as the time from the date of the dosimetric dose to the first occurrence of treatment withdrawal, decision to seek additional therapy, study removal, disease progression, alternative therapy, or death.
Outcome measures
| Measure |
Iodine I-131 Tositumomab + CHOP
n=25 Participants
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
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|---|---|
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Time to Treatment Failure
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20.2 Months
Interval 15.2 to 34.2
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SECONDARY outcome
Timeframe: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)Population: ITT-Exposed Population
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs are defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly. Refer to the general AE/SAE module for a complete list of all AEs and SAEs.
Outcome measures
| Measure |
Iodine I-131 Tositumomab + CHOP
n=25 Participants
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
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|---|---|
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Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Any AE
|
25 Participants
|
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Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Any SAE
|
19 Participants
|
SECONDARY outcome
Timeframe: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)Population: ITT-Exposed Population. Only 24 participants had ANC 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 white blood cell that fights infection.
Outcome measures
| Measure |
Iodine I-131 Tositumomab + CHOP
n=24 Participants
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
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|---|---|
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Mean Nadir Value for Absolute Neutrophil Count (ANC)
|
1.8 1000 cells/millimeters cubed (mm^3)
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)Population: ITT-Exposed Population. Only 24 participants had hemoglobin data available.
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 |
Iodine I-131 Tositumomab + CHOP
n=24 Participants
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
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|---|---|
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Mean Nadir Value for Hemoglobin
|
11.2 grams/deciliter (g/dL)
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)Population: ITT-Exposed Population. Only 24 participants had platelet and WBC data available.
Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells.
Outcome measures
| Measure |
Iodine I-131 Tositumomab + CHOP
n=24 Participants
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
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|---|---|
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Mean Nadir Values for Platelets and White Blood Cell (WBC) Count
Platelet count
|
80.7 1000 cells/microliter
Standard Deviation 54.18
|
|
Mean Nadir Values for Platelets and White Blood Cell (WBC) Count
WBC count
|
2.8 1000 cells/microliter
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)Population: ITT-Exposed Population. Only 24 participants had data available.
Hematology parameters include ANC (calculated), hemoglobin, platelet count, and WBC count. Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Time to nadir is defined as the time from Baseline to the time the lowest value recorded following the therapeutic dose.
Outcome measures
| Measure |
Iodine I-131 Tositumomab + CHOP
n=24 Participants
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
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|---|---|
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Time to Nadir for the Indicated Hematology Parameters
ANC
|
42.9 Days
Standard Deviation 5.93
|
|
Time to Nadir for the Indicated Hematology Parameters
Hemoglobin
|
62.1 Days
Standard Deviation 41.35
|
|
Time to Nadir for the Indicated Hematology Parameters
Platelet count
|
45.7 Days
Standard Deviation 31.51
|
|
Time to Nadir for the Indicated Hematology Parameters
WBC count
|
55.9 Days
Standard Deviation 29.43
|
SECONDARY outcome
Timeframe: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)Population: ITT-Exposed Population. Only 24 participants had data available.
Hematology parameters include ANC (calculated), hemoglobin, platelet count, and WBC count. Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Time to recovery to Baseline for the indicated hematologic parameters is defined as the time required for recovery from nadir values to Baseline values.
Outcome measures
| Measure |
Iodine I-131 Tositumomab + CHOP
n=24 Participants
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
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|---|---|
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Time to Recovery From the Indicated Hematology Parameters
ANC
|
49.5 Days
Interval 44.0 to 55.0
|
|
Time to Recovery From the Indicated Hematology Parameters
Hemoglobin
|
84.0 Days
Interval 41.0 to 115.0
|
|
Time to Recovery From the Indicated Hematology Parameters
Platelet count
|
43.5 Days
Interval 42.0 to 50.0
|
|
Time to Recovery From the Indicated Hematology Parameters
WBC count
|
53.0 Days
Interval 50.0 to 84.0
|
SECONDARY outcome
Timeframe: Screening; at Week 7, Week 13, then every 6 months until disease progression or death (up to 143 months)Population: ITT-Exposed Population. Only those participants evaluable for HAMA were analyzed.
The number of participants who developed human anti-murine (mouse) anibodies (HAMA) after treatment was measured. Conversion to HAMA positivity is relative to Screening (participants were evaluable for HAMA analysis if they were HAMA negative at Screening).
Outcome measures
| Measure |
Iodine I-131 Tositumomab + CHOP
n=23 Participants
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
|
|---|---|
|
Number of Participants Negative for Human Anti-Murine (Mouse) Antibody (HAMA) at Screening Who Converted to HAMA Positivity or Remained Negative During the Course of the Study
Positive
|
10 Participants
|
|
Number of Participants Negative for Human Anti-Murine (Mouse) Antibody (HAMA) at Screening Who Converted to HAMA Positivity or Remained Negative During the Course of the Study
Negative
|
13 Participants
|
SECONDARY outcome
Timeframe: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)Population: ITT-Exposed Population
The effects of iodine I-131 tositumomab on the growth and function of hematopoietic progenitor cells was measured as the number of participants who had cytopenia. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Iodine I-131 Tositumomab + CHOP
n=25 Participants
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
|
|---|---|
|
Number of Participants With an Adverse Event of Cytopenia
Thrombocytopenia
|
3 Participants
|
|
Number of Participants With an Adverse Event of Cytopenia
Pancytopenia
|
1 Participants
|
SECONDARY outcome
Timeframe: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)Population: ITT-Exposed Population
Overall survival is defined as the time from the start of treatment to the date of death from any cause.
Outcome measures
| Measure |
Iodine I-131 Tositumomab + CHOP
n=25 Participants
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
|
|---|---|
|
Overall Survival
|
83.1 Months
Interval 56.5 to 121.6
|
Adverse Events
Iodine I-131 Tositumomab + CHOP
Serious events: 19 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Iodine I-131 Tositumomab + CHOP
n=25 participants at risk
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
28.0%
7/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Cardiac disorders
Cardiac failure congestive
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Cardiac disorders
Pericarditis
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Infections and infestations
Herpes zoster
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Infections and infestations
Pneumonia
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Infections and infestations
Sepsis
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Nervous system disorders
Cerebrovascular accident
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Nervous system disorders
Peroneal nerve palsy
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Nervous system disorders
Syncope
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Intussusception
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Renal and urinary disorders
Renal failure
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Renal and urinary disorders
Renal failure acute
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
General disorders
Pyrexia
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Vascular disorders
Orthostatic hypotension
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
Other adverse events
| Measure |
Iodine I-131 Tositumomab + CHOP
n=25 participants at risk
Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
|
|---|---|
|
General disorders
Fatigue
|
84.0%
21/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
General disorders
Pyrexia
|
36.0%
9/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
General disorders
Chills
|
16.0%
4/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
General disorders
Pain
|
16.0%
4/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
General disorders
Chest discomfort
|
12.0%
3/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
General disorders
Mucosal inflammation
|
12.0%
3/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
General disorders
Asthenia
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
General disorders
Early satiety
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
General disorders
Local swelling
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
General disorders
Oedema peripheral
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
General disorders
Chest pain
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
General disorders
Gait disturbance
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
General disorders
Influenza like illness
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
General disorders
Oedema
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Constipation
|
48.0%
12/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Nausea
|
48.0%
12/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
36.0%
9/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
5/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Stomatitis
|
16.0%
4/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Vomiting
|
16.0%
4/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Inguinal hernia
|
12.0%
3/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Abdominal distension
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Dry mouth
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Dyspepsia
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Oral pain
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Anorectal discomfort
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Dysphagia
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Faecal incontinence
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Glossitis
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Haematochezia
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Melaena
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Oral discomfort
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Gastrointestinal disorders
Retching
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Nervous system disorders
Neuropathy peripheral
|
40.0%
10/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Nervous system disorders
Headache
|
28.0%
7/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Nervous system disorders
Dizziness
|
24.0%
6/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Nervous system disorders
Dysgeusia
|
24.0%
6/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Nervous system disorders
Paraesthesia
|
12.0%
3/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Nervous system disorders
Burning sensation
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Nervous system disorders
Balance disorder
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Nervous system disorders
Dysaesthesia
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Nervous system disorders
Hypoaesthesia
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Nervous system disorders
Post herpetic neuralgia
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Nervous system disorders
Syncope
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
5/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
5/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.0%
4/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.0%
4/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.0%
3/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.0%
7/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
5/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
20.0%
5/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
20.0%
5/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
20.0%
5/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Investigations
Platelets <50000 cells/millimeters cubed (mm^3)
|
40.0%
10/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Investigations
WBC < 2000 cells/mm^3
|
40.0%
10/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Investigations
Absolute neutrophil count (CALC) < 1000 cells/mm^3
|
24.0%
6/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Investigations
Hemoglobin < 8.0 grams per deciliter (g/dL)
|
12.0%
3/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
24.0%
6/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Infections and infestations
Folliculitis
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Infections and infestations
Candida infection
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Infections and infestations
Ear infection
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Infections and infestations
Herpes simplex
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Infections and infestations
Herpes zoster
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Infections and infestations
Infection
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Infections and infestations
Oral candidiasis
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Infections and infestations
Pharyngitis
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Infections and infestations
Pseudomonas infection
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Infections and infestations
Staphylococcal infection
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
24.0%
6/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.0%
3/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Blood and lymphatic system disorders
Anaemia
|
24.0%
6/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.0%
3/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Renal and urinary disorders
Pollakiuria
|
16.0%
4/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Renal and urinary disorders
Dysuria
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Renal and urinary disorders
Haematuria
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Renal and urinary disorders
Nocturia
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Renal and urinary disorders
Nephrotic syndrome
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Renal and urinary disorders
Renal failure acute
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
5/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Endocrine disorders
Goitre
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Injury, poisoning and procedural complications
Contusion
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Injury, poisoning and procedural complications
Laceration
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Investigations
Blood pressure increased
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Investigations
Antibody test abnormal
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Investigations
Blood glucose increased
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Investigations
Transaminases increased
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Investigations
Weight decreased
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Investigations
Weight increased
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Vascular disorders
Hypotension
|
16.0%
4/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Vascular disorders
Phlebitis
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Vascular disorders
Thrombophlebitis superficial
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Cardiac disorders
Palpitations
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Cardiac disorders
Tachycardia
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Ear and labyrinth disorders
Vertigo
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Ear and labyrinth disorders
Ear discomfort
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Eye disorders
Conjunctivitis
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Eye disorders
Dry eye
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Eye disorders
Halo vision
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Eye disorders
Vision blurred
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Eye disorders
Vitreous floaters
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Psychiatric disorders
Anxiety
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Psychiatric disorders
Insomnia
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
|
Congenital, familial and genetic disorders
Cardiac septal defect
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
|
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