Trial Outcomes & Findings for S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma (NCT NCT00006721)
NCT ID: NCT00006721
Last Updated: 2025-05-21
Results Overview
Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
571 participants
Primary outcome timeframe
0-2 years
Results posted on
2025-05-21
Participant Flow
Participant milestones
| Measure |
CHOP Only
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
|
CHOP + Rituximab
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
|
CHOP + Tositumomab
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
279
|
275
|
|
Overall Study
Eligible
|
15
|
267
|
265
|
|
Overall Study
Eligible and Began Protocol Therapy
|
14
|
267
|
265
|
|
Overall Study
COMPLETED
|
13
|
254
|
242
|
|
Overall Study
NOT COMPLETED
|
4
|
25
|
33
|
Reasons for withdrawal
| Measure |
CHOP Only
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
|
CHOP + Rituximab
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
|
CHOP + Tositumomab
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
4
|
4
|
|
Overall Study
Refusal Unrelated to Adverse Event
|
1
|
0
|
8
|
|
Overall Study
Progression/Relapse
|
0
|
1
|
2
|
|
Overall Study
Death
|
0
|
1
|
2
|
|
Overall Study
Other - Not Protocol Specified
|
0
|
7
|
7
|
|
Overall Study
Ineligible
|
2
|
12
|
10
|
|
Overall Study
Eligible but no Treatment Received
|
1
|
0
|
0
|
Baseline Characteristics
S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
CHOP + Rituximab
n=267 Participants
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
|
CHOP + Tositumomab
n=265 Participants
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
|
CHOP Only
n=14 Participants
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
|
Total
n=546 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.5 years
n=5 Participants
|
53.3 years
n=7 Participants
|
54.5 years
n=5 Participants
|
54 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
247 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
142 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
299 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
232 Participants
n=5 Participants
|
220 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
466 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
29 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
241 Participants
n=5 Participants
|
238 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
492 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0-2 yearsPopulation: All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.
Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date
Outcome measures
| Measure |
CHOP + Rituximab
n=267 Participants
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
|
CHOP + Tositumomab
n=265 Participants
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
|
CHOP + Tositumomab
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
|
|---|---|---|---|
|
Progression-free Survival at 2 Years
|
76 percentage of participants
|
80 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 0-5 yearsPopulation: All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.
Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date
Outcome measures
| Measure |
CHOP + Rituximab
n=267 Participants
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
|
CHOP + Tositumomab
n=265 Participants
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
|
CHOP + Tositumomab
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
|
|---|---|---|---|
|
Progression-free Survival at 5 Years
|
60 percentage of participants
|
66 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 0-2 yearsPopulation: All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.
Measured from date of registration to date of death due to any cause
Outcome measures
| Measure |
CHOP + Rituximab
n=267 Participants
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
|
CHOP + Tositumomab
n=265 Participants
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
|
CHOP + Tositumomab
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
|
|---|---|---|---|
|
Overall Survival at 2 Years
|
97 percentage of participants
|
93 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 0-5 yearsPopulation: All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.
Measured from date of registration to date of death due to any cause
Outcome measures
| Measure |
CHOP + Rituximab
n=267 Participants
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
|
CHOP + Tositumomab
n=265 Participants
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
|
CHOP + Tositumomab
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
|
|---|---|---|---|
|
Overall Survival at 5 Years
|
92 percentage of participants
|
86 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Assessed 200 days and 365 days after initiation of therapy and then every 6 months until deathPopulation: All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Outcome measures
| Measure |
CHOP + Rituximab
n=267 Participants
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
|
CHOP + Tositumomab
n=265 Participants
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
|
CHOP + Tositumomab
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
|
|---|---|---|---|
|
Objective Response (Confirmed and Unconfirmed Complete and Partial Responses)
|
224 participants
|
223 participants
|
—
|
SECONDARY outcome
Timeframe: Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatmentPopulation: Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal
Outcome measures
| Measure |
CHOP + Rituximab
n=13 Participants
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
|
CHOP + Tositumomab
n=263 Participants
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
|
CHOP + Tositumomab
n=263 Participants
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
|
|---|---|---|---|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Respiratory infection, unk ANC
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
SGOT (AST) increase
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Ataxia (incoordination)
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Bone pain
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Esophagitis/dysphagia
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Fatigue/malaise/lethargy
|
0 Participants
|
11 Participants
|
9 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hypotension
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hypophosphatemia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
ARDS
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Abdominal pain/cramping
|
0 Participants
|
4 Participants
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Allergic reaction
|
0 Participants
|
9 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Anemia
|
0 Participants
|
7 Participants
|
8 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Anorexia
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Anxiety/agitation
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Arrhythmia, NOS
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Arthralgia
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Arthritis
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Thrombosis/embolism
|
0 Participants
|
6 Participants
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Ascites (non-malignant)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Cardiac ischemia/infarction
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Cardiovascular-other
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Cataract
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Catheter related infection
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Cerebrovascular ischemia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Chest pain,not cardio or pleur
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Constipation/bowel obstruction
|
1 Participants
|
5 Participants
|
4 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Cough
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dehydration
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Delusions
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Depression
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Diarrhea without colostomy
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dizziness/light headedness
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Double vision
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dyspepsia/heartburn
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dyspnea
|
0 Participants
|
4 Participants
|
4 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Edema
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Febrile neutropenia
|
1 Participants
|
42 Participants
|
26 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Fever without neutropenia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Fever, NOS
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Tumor lysis syndrome
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Flu-like symptoms-other
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Gastric ulcer
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Gynecomastia
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Headache
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hematologic-other
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hyperglycemia
|
0 Participants
|
10 Participants
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hypertension
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hyperuricemia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hypoalbuminemia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hypokalemia
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hyponatremia
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hypoxia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Ileus
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Urinary frequency/urgency
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Infection w/o 3-4 neutropenia
|
0 Participants
|
4 Participants
|
5 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Infection with 3-4 neutropenia
|
0 Participants
|
14 Participants
|
9 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Infection, unk ANC
|
0 Participants
|
4 Participants
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Insomnia
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Rectal/perirectal pain
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Invol. movement/restlessness
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Joint,muscle,bone-other
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Respiratory infect w/ neutrop
|
0 Participants
|
3 Participants
|
5 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
LVEF decrease/CHF
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Leukopenia
|
4 Participants
|
104 Participants
|
102 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Lymphopenia
|
4 Participants
|
64 Participants
|
68 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Menses changes
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Muscle weakness (not neuro)
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Myalgia
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Myalgia/arthralgia, NOS
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Nausea
|
1 Participants
|
6 Participants
|
10 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Urinary tr infection, unk ANC
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neuro-other
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neuropathic pain
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neutropenia/granulocytopenia
|
8 Participants
|
127 Participants
|
136 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Osteonecrosis
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
PRBC transfusion
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain-other
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pancreatitis
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Platelet transfusion
|
0 Participants
|
1 Participants
|
7 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pleural effusions
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pleuritic pain
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pneumonitis/infiltrates
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pruritus
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Rash/desquamation
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
SGPT (ALT) increase
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Second primary
|
0 Participants
|
0 Participants
|
6 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Seizures
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Vaginal bleeding
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Voice change/stridor/larynx
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Vomiting
|
1 Participants
|
4 Participants
|
10 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Weakness (motor neuropathy)
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Weight loss
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Sensory neuropathy
|
0 Participants
|
10 Participants
|
11 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Sinus tachycardia
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Skin-other
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Speech impairment
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Stomatitis/pharyngitis
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Supraventricular arrhythmia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Syncope
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Thrombocytopenia
|
0 Participants
|
6 Participants
|
47 Participants
|
Adverse Events
CHOP Only
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
CHOP + Rituximab
Serious events: 3 serious events
Other events: 262 other events
Deaths: 0 deaths
CHOP + Tositumomab
Serious events: 16 serious events
Other events: 261 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CHOP Only
n=13 participants at risk
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
|
CHOP + Rituximab
n=263 participants at risk
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
|
CHOP + Tositumomab
n=263 participants at risk
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.76%
2/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Blood and lymphatic system disorders
Hematologic-other
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
1.1%
3/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Blood and lymphatic system disorders
Platelet transfusion
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.38%
1/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Cardiac disorders
LVEF decrease/CHF
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.38%
1/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.38%
1/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Infections and infestations
Infection w/o 3-4 neutropenia
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.76%
2/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Infections and infestations
Respiratory infect w/ neutrop
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.38%
1/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Investigations
Neutropenia/granulocytopenia
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.38%
1/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
2.3%
6/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Nervous system disorders
Cerebrovascular ischemia
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.38%
1/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.38%
1/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Vascular disorders
Thrombosis/embolism
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.38%
1/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
Other adverse events
| Measure |
CHOP Only
n=13 participants at risk
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
|
CHOP + Rituximab
n=263 participants at risk
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
|
CHOP + Tositumomab
n=263 participants at risk
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
38.5%
5/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
67.3%
177/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
73.0%
192/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
1/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
16.0%
42/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
9.1%
24/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Cardiac disorders
Sinus tachycardia
|
7.7%
1/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Endocrine disorders
Hypothyroidism
|
7.7%
1/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
15.4%
2/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
23.2%
61/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
17.9%
47/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Gastrointestinal disorders
Constipation/bowel obstruction
|
30.8%
4/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
40.3%
106/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
37.6%
99/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Gastrointestinal disorders
Diarrhea without colostomy
|
23.1%
3/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
21.7%
57/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
23.2%
61/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
14.4%
38/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
15.2%
40/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Gastrointestinal disorders
Esophagitis/dysphagia
|
7.7%
1/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
6.5%
17/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Gastrointestinal disorders
GI-other
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
6.1%
16/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Gastrointestinal disorders
Nausea
|
46.2%
6/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
56.7%
149/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
65.8%
173/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis
|
38.5%
5/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
34.2%
90/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
31.9%
84/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Gastrointestinal disorders
Vomiting
|
38.5%
5/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
21.3%
56/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
31.6%
83/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
General disorders
Edema
|
15.4%
2/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
17.1%
45/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
12.5%
33/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
General disorders
Fatigue/malaise/lethargy
|
53.8%
7/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
78.7%
207/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
75.3%
198/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
General disorders
Fever without neutropenia
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
13.3%
35/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
9.1%
24/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
General disorders
Fever, NOS
|
7.7%
1/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
General disorders
Pain-other
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
21.7%
57/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
16.0%
42/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
General disorders
Rigors/chills
|
15.4%
2/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
24.7%
65/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
11.0%
29/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
General disorders
Sweating
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
21.3%
56/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
12.5%
33/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Immune system disorders
Allergic reaction
|
7.7%
1/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
18.6%
49/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Infections and infestations
Infection w/o 3-4 neutropenia
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
16.0%
42/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
14.8%
39/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Infections and infestations
Infection with 3-4 neutropenia
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
6.5%
17/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Infections and infestations
Respiratory infect w/o neutrop
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
5.7%
15/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
5.3%
14/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Investigations
Alkaline phosphatase increase
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
8.4%
22/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
5.7%
15/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Investigations
Creatinine increase
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
6.5%
17/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
5.7%
15/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Investigations
Leukopenia
|
84.6%
11/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
71.1%
187/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
77.9%
205/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Investigations
Lymphopenia
|
53.8%
7/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
55.1%
145/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
58.9%
155/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Investigations
Neutropenia/granulocytopenia
|
76.9%
10/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
66.2%
174/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
71.1%
187/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Investigations
SGOT (AST) increase
|
15.4%
2/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
15.6%
41/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
17.1%
45/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Investigations
SGPT (ALT) increase
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
9.9%
26/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
15.6%
41/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Investigations
Thrombocytopenia
|
23.1%
3/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
29.3%
77/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
53.2%
140/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Investigations
Weight loss
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
9.9%
26/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
11.8%
31/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
23.1%
3/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
24.0%
63/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
22.4%
59/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
15.4%
2/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
8.0%
21/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.7%
1/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.4%
2/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
30.0%
79/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
29.3%
77/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.7%
1/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
8.4%
22/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
5.7%
15/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.7%
1/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
9.1%
24/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
5.7%
15/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
5.7%
15/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
6.1%
16/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
8.4%
22/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
14.1%
37/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
15.6%
41/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
1/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
6.1%
16/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Chest pain,not cardio or pleur
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
7.6%
20/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Joint,muscle,bone-other
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
5.3%
14/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
6.5%
17/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
24.0%
63/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
21.7%
57/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia/arthralgia, NOS
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
9.5%
25/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
15.2%
40/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Nervous system disorders
Dizziness/light headedness
|
7.7%
1/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
8.4%
22/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
7.6%
20/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Nervous system disorders
Headache
|
23.1%
3/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
23.2%
61/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
19.8%
52/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Nervous system disorders
Sensory neuropathy
|
53.8%
7/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
45.6%
120/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
45.2%
119/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Nervous system disorders
Taste disturbance
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
11.0%
29/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
11.4%
30/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Nervous system disorders
Weakness (motor neuropathy)
|
15.4%
2/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
10.3%
27/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
8.4%
22/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Psychiatric disorders
Anxiety/agitation
|
7.7%
1/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
12.9%
34/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
14.4%
38/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Psychiatric disorders
Depression
|
15.4%
2/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
7.6%
20/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
11.8%
31/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Psychiatric disorders
Insomnia
|
15.4%
2/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
22.8%
60/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
22.4%
59/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
6.1%
16/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
8.0%
21/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.7%
1/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
8.7%
23/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
8.0%
21/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
1/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
27.0%
71/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
16.3%
43/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.4%
2/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
19.8%
52/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
16.7%
44/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
15.4%
2/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
84.6%
11/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
66.9%
176/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
57.4%
151/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
7.7%
1/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Skin and subcutaneous tissue disorders
Pigmentation changes/yellowing
|
7.7%
1/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
6.5%
17/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
6.1%
16/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
15.4%
2/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
14.1%
37/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
16.7%
44/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
6.1%
16/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Vascular disorders
Flushing
|
7.7%
1/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Vascular disorders
Hot flashes
|
0.00%
0/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
5.3%
14/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
6.1%
16/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
0.00%
0/263 • Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
|
Additional Information
Study Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place