Trial Outcomes & Findings for Rituximab and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Non-Hodgkin's Lymphoma (NCT NCT00274924)
NCT ID: NCT00274924
Last Updated: 2023-06-29
Results Overview
2-year progression-free survival is defined as the probability of patients who remain alive and progression free at 2 years from study entry. The method of Kaplan and Meier (1958) was used to estimate PFS.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Assessed every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.
Results posted on
2023-06-29
Participant Flow
Participants were recruited from Eastern Cooperative Oncology Group (ECOG) member institutions between 4/7/2006 and 8/5/2009. The first patient was accrued on 9/26/2006.
Participant milestones
| Measure |
Group I (PET Positive)
Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET positive after 3 cycles of R-CHOP received Rituximab 375 mg/m2 IV Day 1, Ifosfamide 5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2, Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day 2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil count (ANC) recovery every 14 days for 4 cycles .
|
Group II (PET Negative)
Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
|
No Mid-Treatment PET
Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who did not have mid-treatment PET scan for any reasons came off study and continued to be followed up for disease progression and survival.
|
|---|---|---|---|
|
Step 1 (R-CHOP X 3 Cycles)
STARTED
|
17
|
77
|
6
|
|
Step 1 (R-CHOP X 3 Cycles)
Treated
|
17
|
77
|
5
|
|
Step 1 (R-CHOP X 3 Cycles)
Eligible and Treated
|
13
|
63
|
4
|
|
Step 1 (R-CHOP X 3 Cycles)
COMPLETED
|
13
|
63
|
0
|
|
Step 1 (R-CHOP X 3 Cycles)
NOT COMPLETED
|
4
|
14
|
6
|
|
Step 2 (Tx Based on Mid-treatment PET)
STARTED
|
17
|
76
|
0
|
|
Step 2 (Tx Based on Mid-treatment PET)
Eligible and Treated
|
13
|
61
|
0
|
|
Step 2 (Tx Based on Mid-treatment PET)
COMPLETED
|
10
|
58
|
0
|
|
Step 2 (Tx Based on Mid-treatment PET)
NOT COMPLETED
|
7
|
18
|
0
|
Reasons for withdrawal
| Measure |
Group I (PET Positive)
Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET positive after 3 cycles of R-CHOP received Rituximab 375 mg/m2 IV Day 1, Ifosfamide 5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2, Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day 2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil count (ANC) recovery every 14 days for 4 cycles .
|
Group II (PET Negative)
Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
|
No Mid-Treatment PET
Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who did not have mid-treatment PET scan for any reasons came off study and continued to be followed up for disease progression and survival.
|
|---|---|---|---|
|
Step 1 (R-CHOP X 3 Cycles)
Patient ineligible
|
4
|
14
|
1
|
|
Step 1 (R-CHOP X 3 Cycles)
Did not start treatment
|
0
|
0
|
1
|
|
Step 1 (R-CHOP X 3 Cycles)
Adverse Event
|
0
|
0
|
1
|
|
Step 1 (R-CHOP X 3 Cycles)
Withdrawal by Subject
|
0
|
0
|
1
|
|
Step 1 (R-CHOP X 3 Cycles)
Lost to Follow-up
|
0
|
0
|
1
|
|
Step 1 (R-CHOP X 3 Cycles)
Other complicating disease
|
0
|
0
|
1
|
|
Step 2 (Tx Based on Mid-treatment PET)
Patient ineligible
|
4
|
15
|
0
|
|
Step 2 (Tx Based on Mid-treatment PET)
Adverse Event
|
1
|
0
|
0
|
|
Step 2 (Tx Based on Mid-treatment PET)
Withdrawal by Subject
|
1
|
0
|
0
|
|
Step 2 (Tx Based on Mid-treatment PET)
Other complicating disease
|
1
|
0
|
0
|
|
Step 2 (Tx Based on Mid-treatment PET)
Death
|
0
|
1
|
0
|
|
Step 2 (Tx Based on Mid-treatment PET)
Lack of Efficacy
|
0
|
1
|
0
|
|
Step 2 (Tx Based on Mid-treatment PET)
Alternative therapy
|
0
|
1
|
0
|
Baseline Characteristics
Rituximab and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Group I (PET Positive)
n=13 Participants
Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET positive after 3 cycles of R-CHOP received Rituximab 375 mg/m2 IV Day 1, Ifosfamide 5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2, Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day 2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil count (ANC) recovery every 14 days for 4 cycles .
|
Group II (PET Negative)
n=63 Participants
Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
|
No Mid-Treatment PET
n=4 Participants
Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who did not have mid-treatment PET scan for any reasons came off study and continued to be followed up for disease progression and survival.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
63 years
n=7 Participants
|
54 years
n=5 Participants
|
62 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Assessed every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.2-year progression-free survival is defined as the probability of patients who remain alive and progression free at 2 years from study entry. The method of Kaplan and Meier (1958) was used to estimate PFS.
Outcome measures
| Measure |
Group I (PET Negative)
n=61 Participants
Eligible and treated patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
|
Group II (PET Positive)
n=13 Participants
Eligible and treated patients who were PET positive after 3 cycles of R-CHOP received 4 cycles of R-ICE.
|
|---|---|---|
|
2-year Progression-Free Survival (PFS)
|
0.76 probability
Interval 0.65 to 0.84
|
0.42 probability
Interval 0.19 to 0.63
|
SECONDARY outcome
Timeframe: Every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.5-year overall survival is defined as the probability of patients who remain alive at 5 years from study entry. The method of Kaplan and Meier (1958) was used to estimate overall survival.
Outcome measures
| Measure |
Group I (PET Negative)
n=61 Participants
Eligible and treated patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
|
Group II (PET Positive)
n=13 Participants
Eligible and treated patients who were PET positive after 3 cycles of R-CHOP received 4 cycles of R-ICE.
|
|---|---|---|
|
5-year Overall Survival
|
0.77 probability
Interval 0.49 to 0.91
|
0.69 probability
Interval 0.43 to 0.85
|
Adverse Events
Step 1 - All Treated Patients
Serious events: 58 serious events
Other events: 97 other events
Deaths: 0 deaths
Step 2 - Mid-treatment PET Positive
Serious events: 17 serious events
Other events: 17 other events
Deaths: 0 deaths
Step 2 - Mid-treatment PET Negative
Serious events: 25 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Step 1 - All Treated Patients
n=99 participants at risk
All treated patients regardless of eligibility.
|
Step 2 - Mid-treatment PET Positive
n=17 participants at risk
Patients who were mid-treatment PET positive and who received R-ICE in step 2 regardless of eligibility.
|
Step 2 - Mid-treatment PET Negative
n=76 participants at risk
Patients who were mid-treatment PET negative and who received additional R-CHOP in step 2 regardless of eligibility.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.0%
1/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
2/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
2/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Gastrointestinal disorders
Nausea
|
3.0%
3/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Gastrointestinal disorders
Perforation, small bowel NOS
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Infections and infestations
Colitis, infectious (e.g. C.diff)
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Blood and lymphatic system disorders
Anemia
|
5.1%
5/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
41.2%
7/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
6.6%
5/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Investigations
Leukocytes decreased
|
35.4%
35/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
58.8%
10/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
18.4%
14/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Investigations
Lymphopenia
|
9.1%
9/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
47.1%
8/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
7.9%
6/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Investigations
Neutrophils decreased
|
41.4%
41/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
64.7%
11/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
15.8%
12/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Investigations
Platelets decreased
|
8.1%
8/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
88.2%
15/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
6.6%
5/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Cardiac disorders
Sinus tachycardia
|
1.0%
1/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Vascular disorders
Hypotension
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
General disorders
Fatigue
|
4.0%
4/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
General disorders
Fever w/o neutropenia
|
1.0%
1/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Psychiatric disorders
Insomnia
|
1.0%
1/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Investigations
Weight gain
|
1.0%
1/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Investigations
Coagulation-other
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.1%
8/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
3.9%
3/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Infections and infestations
Infection w/ gr3-4 neut, lung
|
1.0%
1/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Infections and infestations
Infection w/ gr3-4 neut, peritoneal
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Infections and infestations
Infection w/ gr3-4 neut, upper airway
|
1.0%
1/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Infections and infestations
Infection w/ gr3-4 neut, urinary tract
|
1.0%
1/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Infections and infestations
Infection w/ gr3-4 neut, vulva
|
1.0%
1/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Infections and infestations
Infection Gr0-2 neut, joint
|
1.0%
1/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Infections and infestations
Infection Gr0-2 neut, larynx
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Infections and infestations
Infection Gr0-2 neut, upper airway
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Infections and infestations
Infection w/ gr3-4 neut, blood
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
1.0%
1/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Investigations
Blood bilirubin increased
|
1.0%
1/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.1%
5/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.0%
1/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.0%
1/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.0%
1/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Nervous system disorders
Neuropathy-motor
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Nervous system disorders
Neuropathy-sensory
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Nervous system disorders
Syncope
|
1.0%
1/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Nervous system disorders
Head/headache
|
1.0%
1/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
(ARDS)
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Immune system disorders
Cytokine release syndrome
|
1.0%
1/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Injury, poisoning and procedural complications
Vascular access,Thrombosis/embolism
|
1.0%
1/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
Other adverse events
| Measure |
Step 1 - All Treated Patients
n=99 participants at risk
All treated patients regardless of eligibility.
|
Step 2 - Mid-treatment PET Positive
n=17 participants at risk
Patients who were mid-treatment PET positive and who received R-ICE in step 2 regardless of eligibility.
|
Step 2 - Mid-treatment PET Negative
n=76 participants at risk
Patients who were mid-treatment PET negative and who received additional R-CHOP in step 2 regardless of eligibility.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Blood and lymphatic system disorders
Anemia
|
73.7%
73/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
94.1%
16/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
75.0%
57/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Investigations
Leukocytes decreased
|
39.4%
39/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
47.1%
8/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
32.9%
25/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Investigations
Lymphopenia
|
11.1%
11/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
17.6%
3/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
13.2%
10/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Investigations
Neutrophils decreased
|
25.3%
25/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
17.6%
3/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
10.5%
8/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Investigations
Platelets decreased
|
23.2%
23/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
47.1%
8/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
17.1%
13/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Vascular disorders
Hypertension
|
5.1%
5/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Vascular disorders
Hypotension
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
General disorders
Fatigue
|
71.7%
71/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
94.1%
16/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
65.8%
50/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
General disorders
Fever w/o neutropenia
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
23.5%
4/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
2.6%
2/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Psychiatric disorders
Insomnia
|
27.3%
27/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
11.8%
2/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
7.9%
6/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
General disorders
Rigors/chills
|
6.1%
6/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Investigations
Weight loss
|
6.1%
6/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Vascular disorders
Flushing
|
7.1%
7/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
58.6%
58/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
41.2%
7/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
40.8%
31/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
General disorders
Injection site reaction
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
5.1%
5/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
6.1%
6/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
22/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
35.3%
6/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
11.8%
9/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Gastrointestinal disorders
Constipation
|
52.5%
52/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
17.6%
3/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
18.4%
14/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
16.2%
16/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
11.8%
2/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
11.8%
9/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
6/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
9.1%
9/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
17.6%
3/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.3%
4/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Gastrointestinal disorders
Nausea
|
50.5%
50/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
58.8%
10/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
32.9%
25/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Gastrointestinal disorders
Salivary
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Nervous system disorders
Taste disturbance
|
22.2%
22/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
17.6%
3/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
18.4%
14/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
15.2%
15/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
23.5%
4/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
3.9%
3/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Renal and urinary disorders
Urinary hemorrhage NOS
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
11.8%
2/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Infections and infestations
Infection w/ unk ANC skin (cellulitis)
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
General disorders
Edema limb
|
5.1%
5/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.1%
11/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
10.5%
8/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Investigations
Alkaline phosphatase increased
|
22.2%
22/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
41.2%
7/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.3%
4/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
12.1%
12/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
17.6%
3/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
11.8%
9/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
20.2%
20/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
41.2%
7/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
19.7%
15/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.1%
5/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.3%
4/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.1%
10/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
17.6%
3/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.3%
4/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Investigations
Creatinine increased
|
5.1%
5/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
17.6%
3/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
58.6%
58/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
52.9%
9/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
42.1%
32/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.1%
5/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
11.8%
2/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
2.6%
2/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
17.6%
3/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.1%
6/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
17.6%
3/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
2.6%
2/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Investigations
Metabolic/Laboratory-other
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Nervous system disorders
Dizziness
|
9.1%
9/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
11.8%
2/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Nervous system disorders
Extrapyramidal movement
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Nervous system disorders
Neuropathy-sensory
|
50.5%
50/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
35.3%
6/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
51.3%
39/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Gastrointestinal disorders
Abdomen, pain
|
9.1%
9/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Nervous system disorders
Head/headache
|
14.1%
14/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
17.6%
3/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
2.6%
2/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
14.1%
14/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
General disorders
Pain NOS
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
11.8%
2/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
7.9%
6/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
9/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
23.5%
4/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
7.9%
6/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Gastrointestinal disorders
Fistula oral cavity
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
11.8%
2/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reaction
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
11.8%
2/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.3%
4/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
1.3%
1/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Immune system disorders
Cytokine release syndrome
|
5.1%
5/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/99 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
5.9%
1/17 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
0.00%
0/76 • Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place