Trial Outcomes & Findings for SWOG-9704 Chemoradiotherapy and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma (NCT NCT00004031)
NCT ID: NCT00004031
Last Updated: 2021-02-02
Results Overview
Percentage of participants surviving 2 years post registration
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
397 participants
Primary outcome timeframe
up to 2 years post registration
Results posted on
2021-02-02
Participant Flow
397 participants were registered, of whom 27 were ineligible. Of the 370 eligible participants, 117 were excluded from randomization and so only 253 underwent randomization.
Participant milestones
| Measure |
CHOP/CHOP-R x 3
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cycles
rituximab: 375 mg/m2 IV every 21 days
CHOP regimen
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
bone marrow ablation with stem cell support
|
CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant.
rituximab: 375 mg/m2 IV every 21 days
CHOP regimen
carmustine
cyclophosphamide
doxorubicin hydrochloride
etoposide
prednisone
vincristine sulfate
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
radiation therapy
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
125
|
|
Overall Study
Assessed for Adverse Events
|
123
|
113
|
|
Overall Study
COMPLETED
|
103
|
104
|
|
Overall Study
NOT COMPLETED
|
25
|
21
|
Reasons for withdrawal
| Measure |
CHOP/CHOP-R x 3
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cycles
rituximab: 375 mg/m2 IV every 21 days
CHOP regimen
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
bone marrow ablation with stem cell support
|
CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant.
rituximab: 375 mg/m2 IV every 21 days
CHOP regimen
carmustine
cyclophosphamide
doxorubicin hydrochloride
etoposide
prednisone
vincristine sulfate
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
radiation therapy
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
0
|
|
Overall Study
Refusal unrelated to adverse events
|
2
|
11
|
|
Overall Study
Progression/relapse
|
9
|
4
|
|
Overall Study
Death
|
3
|
1
|
|
Overall Study
Other- not protocol specified
|
3
|
3
|
|
Overall Study
Reason under review
|
3
|
2
|
Baseline Characteristics
SWOG-9704 Chemoradiotherapy and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
CHOP/CHOP-R x 3
n=128 Participants
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cycles
rituximab: 375 mg/m2 IV every 21 days
CHOP regimen
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
bone marrow ablation with stem cell support
|
CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant
n=125 Participants
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant.
rituximab: 375 mg/m2 IV every 21 days
CHOP regimen
carmustine
cyclophosphamide
doxorubicin hydrochloride
etoposide
prednisone
vincristine sulfate
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
radiation therapy
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|
|
WHO T Cell Histology
WHO T Cell Histology
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
WHO T Cell Histology
Peripheral T, Not otherwise Specified
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Immunophenotyping
B cell CHOP-R
|
76 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Immunophenotyping
B cell CHOP
|
40 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Age, Continuous
|
51.3 years
n=5 Participants
|
49.6 years
n=7 Participants
|
50.6 years
n=5 Participants
|
|
Age, Customized
% >=60 years
|
18 percentage of participants
n=5 Participants
|
20 percentage of participants
n=7 Participants
|
19 percentage of participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
113 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
119 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
WHO B Cell Histology
WHO B Cell Histology
|
114 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
WHO B Cell Histology
Diffuse Large B-Cell,Not Otherwise Specified
|
78 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Stage
Bulky II
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Stage
III
|
3 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Stage
IV
|
78 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Performance status >= 2
|
44 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Elevated LDH
|
104 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
B Symptoms
|
81 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
International Prognostic Index: High
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Extra nodal Sites >=2
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Bone marrow involvement- Yes
|
31 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 2 years post registrationPopulation: Eligible participants that were randomized to study arms.
Percentage of participants surviving 2 years post registration
Outcome measures
| Measure |
CHOP/CHOP-R x 3
n=128 Participants
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cycles
rituximab: 375 mg/m2 IV every 21 days
CHOP regimen
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
bone marrow ablation with stem cell support
|
CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant
n=125 Participants
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant.
rituximab: 375 mg/m2 IV every 21 days
CHOP regimen
carmustine
cyclophosphamide
doxorubicin hydrochloride
etoposide
prednisone
vincristine sulfate
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
radiation therapy
|
|---|---|---|
|
2-year Overall Survival Rates
|
71.1 percentage of participants
Interval 63.2 to 78.9
|
73.7 percentage of participants
Interval 66.0 to 81.4
|
PRIMARY outcome
Timeframe: From registration until deathPopulation: Eligible participants that were randomized to study arms.
Percentage of participants without disease progression up to 2 years post-registration.
Outcome measures
| Measure |
CHOP/CHOP-R x 3
n=128 Participants
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cycles
rituximab: 375 mg/m2 IV every 21 days
CHOP regimen
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
bone marrow ablation with stem cell support
|
CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant
n=125 Participants
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant.
rituximab: 375 mg/m2 IV every 21 days
CHOP regimen
carmustine
cyclophosphamide
doxorubicin hydrochloride
etoposide
prednisone
vincristine sulfate
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
radiation therapy
|
|---|---|---|
|
2 Year Progression-free Survival
|
55.4 percentage of participants
Interval 46.9 to 64.1
|
69.1 percentage of participants
Interval 61.0 to 77.1
|
SECONDARY outcome
Timeframe: Duration of treatment and follow up until death or 3 years post registrationPopulation: Patients who received at least one dose of protocol treatment.
Adverse Events (AEs) are reported by CTCAE Version 2.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. Higher grades indicate higher severity of adverse events.
Outcome measures
| Measure |
CHOP/CHOP-R x 3
n=123 Participants
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cycles
rituximab: 375 mg/m2 IV every 21 days
CHOP regimen
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
bone marrow ablation with stem cell support
|
CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant
n=113 Participants
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant.
rituximab: 375 mg/m2 IV every 21 days
CHOP regimen
carmustine
cyclophosphamide
doxorubicin hydrochloride
etoposide
prednisone
vincristine sulfate
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
radiation therapy
|
|---|---|---|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Abdominal pain/cramping
|
8 Participants
|
9 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alkaline phosphatase increase
|
9 Participants
|
15 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Allergic reaction
|
0 Participants
|
8 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Allergic rhinitis
|
4 Participants
|
5 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alopecia
|
43 Participants
|
36 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anemia
|
57 Participants
|
89 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anorexia
|
8 Participants
|
32 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anxiety/agitation
|
2 Participants
|
12 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Apnea
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Arthralgia
|
5 Participants
|
15 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Arthritis
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Ataxia (incoordination)
|
2 Participants
|
6 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Bicarbonate decrease
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Bilirubin increase
|
3 Participants
|
6 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Blurred vision
|
0 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Bone pain
|
6 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Bruising
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
CO diffusion capacity decrease
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac ischemia/infarction
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiovascular-other
|
0 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Catheter related infection
|
1 Participants
|
11 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Chest pain,not cardio or pleur
|
4 Participants
|
9 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Colitis
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Confusion
|
1 Participants
|
5 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Conjunctivitis
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Constipation/bowel obstruction
|
14 Participants
|
24 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cough
|
15 Participants
|
32 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Creatinine increase
|
2 Participants
|
7 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cushingoid appearance
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dehydration
|
3 Participants
|
7 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Delusions
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Depression
|
3 Participants
|
12 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Diarrhea without colostomy
|
13 Participants
|
49 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dizziness/light headedness
|
9 Participants
|
8 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dizziness/vertigo, NOS
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Double vision
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dry skin
|
1 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dyspepsia/heartburn
|
6 Participants
|
10 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dyspnea
|
17 Participants
|
26 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dysuria
|
1 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Ear-other
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Earache
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Edema
|
9 Participants
|
32 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Endocrine-other
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Epistaxis
|
0 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Erectile impotence
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Eryth/rash/eruption/desq, NOS
|
1 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Erythema multiforme/blistering
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Esophagitis/dysphagia
|
3 Participants
|
9 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Eye-other
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
FEV1 decrease
|
0 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue/malaise/lethargy
|
47 Participants
|
67 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Febrile neutropenia
|
10 Participants
|
44 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fever without neutropenia
|
5 Participants
|
17 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fever, NOS
|
5 Participants
|
5 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Flu-like symptoms-other
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Flushing
|
1 Participants
|
18 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Focal dermatitis
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
GGT increase
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
GI Mucositis, NOS
|
1 Participants
|
10 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
GI-other
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
GU-other
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
GVHD
|
0 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Gastritis
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Gynecomastia
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hallucinations
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hand-foot skin reaction
|
1 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Headache
|
6 Participants
|
26 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hematuria
|
0 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemorrhage-other
|
1 Participants
|
5 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hiccoughs
|
0 Participants
|
6 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hot flashes
|
3 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyperglycemia
|
4 Participants
|
21 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyperkalemia
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypermagnesemia
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypernatremia
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypertension
|
0 Participants
|
5 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyperuricemia
|
2 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypoalbuminemia
|
1 Participants
|
10 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypocalcemia
|
1 Participants
|
13 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypoglycemia
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypokalemia
|
2 Participants
|
10 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypomagnesemia
|
0 Participants
|
6 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyponatremia
|
2 Participants
|
9 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypophosphatemia
|
0 Participants
|
9 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypotension
|
1 Participants
|
15 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypoxia
|
0 Participants
|
6 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infection w/o 3-4 neutropenia
|
4 Participants
|
13 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infection with 3-4 neutropenia
|
6 Participants
|
17 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infection, unk ANC
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inner ear-hearing loss
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Insomnia
|
9 Participants
|
15 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Invol. movement/restlessness
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Joint,muscle,bone-other
|
4 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Keratitis
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
LVEF decrease/CHF
|
2 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Leukopenia
|
68 Participants
|
81 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Liver-other
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Local injection site reaction
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lung-other
|
1 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphedema
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphopenia
|
59 Participants
|
80 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Melena/ GI bleeding
|
1 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Memory loss
|
2 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Menses changes
|
1 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Metabolic-other
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mouth dryness
|
1 Participants
|
9 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Muscle weakness (not neuro)
|
4 Participants
|
10 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Myalgia
|
15 Participants
|
19 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Myalgia/arthralgia, NOS
|
2 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nail changes
|
3 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nausea
|
31 Participants
|
66 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neuro-other
|
1 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neuropathic pain
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neutropenia/granulocytopenia
|
60 Participants
|
89 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
PRBC transfusion
|
3 Participants
|
32 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain-other
|
15 Participants
|
17 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Palpitations
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Partial thromboplast time inc
|
1 Participants
|
5 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pericar. effusion/pericarditis
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Personality/behavioral change
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Petechiae/purpura
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Phlebitis
|
3 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pigmentation changes/yellowing
|
3 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Platelet transfusion
|
2 Participants
|
37 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pleural effusions
|
1 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pneumonitis/infiltrates
|
2 Participants
|
10 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Proctitis
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Proteinuria
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Prothrombin time increase
|
1 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pruritus
|
3 Participants
|
7 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pulmonary edema
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pulmonary fibrosis
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
RT-GI mucositis, NOS
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
RT-esophagitis
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
RT-focal dermatitis, NOS
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
RT-pain
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
RT-pharyngeal dysphagia
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rash/desquamation
|
7 Participants
|
35 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rectal bleeding/hematochezia
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rectal/anal fistula
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rectal/perirectal pain
|
0 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Renal failure
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Reportable adverse event, NOS
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Respiratory infect w/ neutrop
|
0 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Respiratory infect w/o neutrop
|
4 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Respiratory infection, unk ANC
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rigors/chills
|
2 Participants
|
15 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
SGOT (AST) increase
|
9 Participants
|
15 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
SGPT (ALT) increase
|
2 Participants
|
9 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
SIADH
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Salivary gland changes
|
0 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Second primary
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sense of smell
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sensory neuropathy
|
46 Participants
|
40 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sinus bradycardia
|
2 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sinus tachycardia
|
2 Participants
|
12 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Skin-other
|
3 Participants
|
6 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Somnolence/consciousness loss
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Stomatitis/pharyngitis
|
12 Participants
|
57 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Supraventricular arrhythmia
|
0 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Surgery-wound infection
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sweating
|
9 Participants
|
11 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Syncope
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Syndrome-other
|
0 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Taste disturbance
|
7 Participants
|
16 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Thrombocytopenia
|
15 Participants
|
61 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Thrombosis/embolism
|
3 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Transplant-diarrhea
|
0 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Transplant-granulocytopenia
|
0 Participants
|
5 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Transplant-leukopenia
|
0 Participants
|
11 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Transplant-pRBC transfusion
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Transplant-plt transfusion
|
1 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Transplant-rash/desquamation
|
0 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Transplant-stomatitis/pharyng
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Transplant-thrombocytopenia
|
0 Participants
|
13 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Tremor
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Urinary electrolyte wasting
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Urinary frequency/urgency
|
1 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Urinary retention
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Urinary tr infect w/ neutrop
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Urinary tr infect w/o neutrop
|
2 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
VOD associated weight gain
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vaginal bleeding
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vaginal dryness
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vaginitis
|
0 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vision,NOS
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Voice change/stridor/larynx
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vomiting
|
15 Participants
|
40 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Weakness (motor neuropathy)
|
13 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Weight gain
|
7 Participants
|
8 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Weight loss
|
2 Participants
|
11 Participants
|
Adverse Events
CHOP/CHOP-R x 3
Serious events: 4 serious events
Other events: 108 other events
Deaths: 51 deaths
CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant
Serious events: 4 serious events
Other events: 106 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
CHOP/CHOP-R x 3
n=123 participants at risk
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cyclesXXrituximab: 375 mg/m2 IV every 21 daysXXCHOP regimenXXcyclophosphamideXXdoxorubicin hydrochlorideXXprednisoneXXvincristine sulfateXXbone marrow ablation with stem cell support
|
CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant
n=113 participants at risk
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant.XXrituximab: 375 mg/m2 IV every 21 daysXXCHOP regimenXXcarmustineXXcyclophosphamideXXdoxorubicin hydrochlorideXXetoposideXXprednisoneXXvincristine sulfateXXbone marrow ablation with stem cell supportXXperipheral blood stem cell transplantationXXradiation therapy
|
|---|---|---|
|
Cardiac disorders
LVEF decrease/CHF
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
0.00%
0/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
0.88%
1/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
General disorders
Reportable adverse event, NOS
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
0.00%
0/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
General disorders
Syndrome-other
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
0.88%
1/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Infections and infestations
Infection with 3-4 neutropenia
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
0.00%
0/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
0.00%
0/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
0.88%
1/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
0.88%
1/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/infiltrates
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
1.8%
2/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
0.88%
1/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
Other adverse events
| Measure |
CHOP/CHOP-R x 3
n=123 participants at risk
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cyclesXXrituximab: 375 mg/m2 IV every 21 daysXXCHOP regimenXXcyclophosphamideXXdoxorubicin hydrochlorideXXprednisoneXXvincristine sulfateXXbone marrow ablation with stem cell support
|
CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant
n=113 participants at risk
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant.XXrituximab: 375 mg/m2 IV every 21 daysXXCHOP regimenXXcarmustineXXcyclophosphamideXXdoxorubicin hydrochlorideXXetoposideXXprednisoneXXvincristine sulfateXXbone marrow ablation with stem cell supportXXperipheral blood stem cell transplantationXXradiation therapy
|
|---|---|---|
|
General disorders
Fever without neutropenia
|
4.1%
5/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
15.0%
17/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
General disorders
Pain-other
|
12.2%
15/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
15.0%
17/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Blood and lymphatic system disorders
Anemia
|
46.3%
57/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
78.8%
89/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.1%
10/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
38.9%
44/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Blood and lymphatic system disorders
PRBC transfusion
|
2.4%
3/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
28.3%
32/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Blood and lymphatic system disorders
Platelet transfusion
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
32.7%
37/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Cardiac disorders
Sinus tachycardia
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
10.6%
12/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
6.5%
8/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
8.0%
9/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Gastrointestinal disorders
Constipation/bowel obstruction
|
11.4%
14/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
21.2%
24/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Gastrointestinal disorders
Diarrhea without colostomy
|
10.6%
13/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
43.4%
49/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
4.9%
6/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
8.8%
10/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Gastrointestinal disorders
Esophagitis/dysphagia
|
2.4%
3/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
8.0%
9/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Gastrointestinal disorders
GI Mucositis, NOS
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
8.8%
10/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Gastrointestinal disorders
Mouth dryness
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
8.0%
9/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Gastrointestinal disorders
Nausea
|
25.2%
31/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
58.4%
66/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis
|
9.8%
12/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
49.6%
56/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Gastrointestinal disorders
Vomiting
|
12.2%
15/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
35.4%
40/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
General disorders
Edema
|
7.3%
9/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
28.3%
32/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
General disorders
Fatigue/malaise/lethargy
|
38.2%
47/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
59.3%
67/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
General disorders
Rigors/chills
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
13.3%
15/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
General disorders
Sweating
|
7.3%
9/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
9.7%
11/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
7.1%
8/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Infections and infestations
Infection w/o 3-4 neutropenia
|
3.3%
4/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
11.5%
13/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Infections and infestations
Infection with 3-4 neutropenia
|
4.1%
5/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
15.0%
17/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Injury, poisoning and procedural complications
Catheter related infection
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
9.7%
11/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Investigations
Alkaline phosphatase increase
|
7.3%
9/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
13.3%
15/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Investigations
Bilirubin increase
|
2.4%
3/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
5.3%
6/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Investigations
Creatinine increase
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
6.2%
7/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Investigations
Leukopenia
|
55.3%
68/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
71.7%
81/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Investigations
Lymphopenia
|
48.0%
59/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
70.8%
80/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Investigations
Neutropenia/granulocytopenia
|
48.8%
60/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
78.8%
89/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Investigations
SGOT (AST) increase
|
7.3%
9/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
13.3%
15/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Investigations
SGPT (ALT) increase
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
8.0%
9/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Investigations
Thrombocytopenia
|
12.2%
15/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
54.0%
61/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Investigations
Transplant-leukopenia
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
9.7%
11/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Investigations
Transplant-thrombocytopenia
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
11.5%
13/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Investigations
Weight gain
|
5.7%
7/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
7.1%
8/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Investigations
Weight loss
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
9.7%
11/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.5%
8/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
28.3%
32/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
3/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
6.2%
7/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.3%
4/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
18.6%
21/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
8.8%
10/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
11.5%
13/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
8.8%
10/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
5.3%
6/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
8.0%
9/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
8.0%
9/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.1%
5/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
13.3%
15/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Chest pain,not cardio or pleur
|
3.3%
4/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
8.0%
9/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not neuro)
|
3.3%
4/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
8.8%
10/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.2%
15/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
16.8%
19/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Nervous system disorders
Ataxia (incoordination)
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
5.3%
6/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Nervous system disorders
Dizziness/light headedness
|
7.3%
9/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
7.1%
8/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Nervous system disorders
Headache
|
4.9%
6/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
23.0%
26/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Nervous system disorders
Sensory neuropathy
|
37.4%
46/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
35.4%
40/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Nervous system disorders
Taste disturbance
|
5.7%
7/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
14.2%
16/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Nervous system disorders
Weakness (motor neuropathy)
|
10.6%
13/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
3.5%
4/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Psychiatric disorders
Anxiety/agitation
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
10.6%
12/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Psychiatric disorders
Depression
|
2.4%
3/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
10.6%
12/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Psychiatric disorders
Insomnia
|
7.3%
9/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
13.3%
15/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.2%
15/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
28.3%
32/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.8%
17/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
23.0%
26/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
5.3%
6/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/infiltrates
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
7.1%
8/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
35.0%
43/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
31.9%
36/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
3/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
6.2%
7/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
5.7%
7/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
31.0%
35/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
2.4%
3/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
5.3%
6/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Vascular disorders
Flushing
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
15.9%
18/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
|
Vascular disorders
Hypotension
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
13.3%
15/113 • Duration of treatment and follow up until death or 3 years post registration
Of 253 eligible participants, 17 did not receive protocol therapy so were not assessed for AEs. Therefore only 236 participants were assessed for AEs.
|
Additional Information
Study Statistician
SWOG Statistics and Data Management Center
Phone: 2066674623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place