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Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00118209
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : April 17, 2020
Last Update Posted : November 17, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Large B Cell Lymphoma
Interventions Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin
Drug: vincristine
Drug: prednisone
Drug: etoposide
Drug: filgrastim
Drug: pegfilgrastim
Enrollment 524
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A - R-CHOP Arm B - DA-EPOCH-R
Hide Arm/Group Description

Patients receive the following treatment:>

  • Rituximab 375 mg/m^2 IV infusion on Day 1 prior to CHOP chemotherapy>
  • Cyclophosphamide 750 mg/m^2 IV on Day 1>
  • Doxorubicin 50 mg/m^2 IV on Day 1>
  • Vincristine 1.4 mg/m^2 IV (2 mg cap) on Day 1>
  • Prednisone 40 mg/m^2/day PO on Days 1-5>
  • filgrastim or pegfilgrastim as defined in the protocol> Required ancillary medications is administered during all cycles as defined in the protocol.> Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6.

Patients receive the following treatment:> Cycle 1 Doses:>

  • Rituximab 375 mg/m^2 IV infusion on Day 1 prior to EPOCH chemotherapy>
  • Doxorubicin 10 mg/m^2/day CIVI on Days 1-4>
  • Etoposide 50 mg/m^2/day CIVI on Days 1-4>
  • Vincristine 0.4 mg/m^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours)>
  • Cyclophosphamide 750 mg/m^2 IV on Day 5 (following completion of 96 hour infusions)>
  • Prednisone 60 mg/m^2 PO BID on Days 1-5>
  • Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC > 5000 after the > nadir (nadir usually between Days 10-12) or for 10 days (Days 6-15) if the ANC is not > being monitored, during every cycle.> Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle.> Required ancillary medications are administered during all cycles as defined in the protocol.> Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6.
Period Title: Overall Study
Started 262 262
Evaluable for Primary Endpoint 250 241
Evaluable for Safety Analysis [1] 243 237
Completed 250 241
Not Completed 12 21
[1]
Evaluable for adverse events
Arm/Group Title Arm A - R-CHOP Arm B - DA-EPOCH-R Total
Hide Arm/Group Description

Patients receive the following treatment:>

  • Rituximab 375 mg/m^2 IV infusion on Day 1 prior to CHOP chemotherapy>
  • Cyclophosphamide 750 mg/m^2 IV on Day 1>
  • Doxorubicin 50 mg/m^2 IV on Day 1>
  • Vincristine 1.4 mg/m^2 IV (2 mg cap) on Day 1>
  • Prednisone 40 mg/m^2/day PO on Days 1-5>
  • filgrastim or pegfilgrastim as defined in the protocol> Required ancillary medications is administered during all cycles as defined in the protocol.> Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6.

Patients receive the following treatment:> Cycle 1 Doses:>

  • Rituximab 375 mg/m^2 IV infusion on Day 1 prior to EPOCH chemotherapy>
  • Doxorubicin 10 mg/m^2/day CIVI on Days 1-4>
  • Etoposide 50 mg/m^2/day CIVI on Days 1-4>
  • Vincristine 0.4 mg/m^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours)>
  • Cyclophosphamide 750 mg/m^2 IV on Day 5 (following completion of 96 hour infusions)>
  • Prednisone 60 mg/m^2 PO BID on Days 1-5>
  • Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC > 5000 after the > nadir (nadir usually between Days 10-12) or for 10 days (Days 6-15) if the ANC is not > being monitored, during every cycle.> Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle.> Required ancillary medications are administered during all cycles as defined in the protocol.> Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6.
Total of all reporting groups
Overall Number of Baseline Participants 250 241 491
Hide Baseline Analysis Population Description
Participants who completed the study in the Participant Flow are included in this analysis.
Age, Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 247 participants 239 participants 486 participants
58.0
(18.0 to 86.0)
58.0
(19.0 to 84.0)
58.0
(18.0 to 86.0)
[1]
Measure Analysis Population Description: Number analyzed in row differs from overall due to missing data.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 249 participants 241 participants 490 participants
Female
116
  46.6%
109
  45.2%
225
  45.9%
Male
133
  53.4%
132
  54.8%
265
  54.1%
[1]
Measure Analysis Population Description: Number analyzed in row differs from overall due to missing data.
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 241 participants 491 participants
Hispanic or Latino
16
   6.4%
15
   6.2%
31
   6.3%
Not Hispanic or Latino
220
  88.0%
214
  88.8%
434
  88.4%
Unknown or Not Reported
14
   5.6%
12
   5.0%
26
   5.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 241 participants 491 participants
American Indian or Alaska Native
2
   0.8%
2
   0.8%
4
   0.8%
Asian
9
   3.6%
8
   3.3%
17
   3.5%
Native Hawaiian or Other Pacific Islander
1
   0.4%
0
   0.0%
1
   0.2%
Black or African American
29
  11.6%
31
  12.9%
60
  12.2%
White
196
  78.4%
189
  78.4%
385
  78.4%
More than one race
2
   0.8%
3
   1.2%
5
   1.0%
Unknown or Not Reported
11
   4.4%
8
   3.3%
19
   3.9%
ECOG Performance Status   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 249 participants 241 participants 490 participants
0
101
  40.6%
113
  46.9%
214
  43.7%
1
119
  47.8%
96
  39.8%
215
  43.9%
2
29
  11.6%
32
  13.3%
61
  12.4%
[1]
Measure Description: Eastern Cooperative Oncology Group PS Scale: 0)Fully active, able to carry on all pre-disease performance without restriction; 1)Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2)Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3)Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4)Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
[2]
Measure Analysis Population Description: The number analyzed in row differs from overall due to missing data.
1.Primary Outcome
Title Progression-Free Survival Rate at 2 and 5 Years
Hide Description

Progression-free survival (PFS) is defined as the time from randomization to progression, relapse, or death from any cause, whichever occurred first. Progression (PD) or Relapse>

  • ≥ 50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders.>
  • Appearance of any new lesion during or after completion of therapy.>
  • PET+ is not a criterion for progressive disease. Patients only with PET+ findings must have evidence of progression on CT or biopsy proven.>

The PFS rate (percentage of participants who are alive and progression-free) at 2 and 5 years Kaplan Meier estimates and 95% Confidence Intervals are reported below.

Time Frame Up to 5 years post-registration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm B - DA-EPOCH-R Arm A - R-CHOP
Hide Arm/Group Description:

Patients receive the following treatment:> Cycle 1 Doses:>

  • Rituximab 375 mg/m^2 IV infusion on Day 1 prior to EPOCH chemotherapy>
  • Doxorubicin 10 mg/m^2/day CIVI on Days 1-4>
  • Etoposide 50 mg/m^2/day CIVI on Days 1-4>
  • Vincristine 0.4 mg/m^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours)>
  • Cyclophosphamide 750 mg/m^2 IV on Day 5 (following completion of 96 hour infusions)>
  • Prednisone 60 mg/m^2 PO BID on Days 1-5>
  • Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC > 5000 after the > nadir (nadir usually between Days 10-12) or for 10 days (Days 6-15) if the ANC is not > being monitored, during every cycle.> Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle.> Required ancillary medications are administered during all cycles as defined in the protocol.> Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6.

Patients receive the following treatment:>

  • Rituximab 375 mg/m^2 IV infusion on Day 1 prior to CHOP chemotherapy>
  • Cyclophosphamide 750 mg/m^2 IV on Day 1>
  • Doxorubicin 50 mg/m^2 IV on Day 1>
  • Vincristine 1.4 mg/m^2 IV (2 mg cap) on Day 1>
  • Prednisone 40 mg/m^2/day PO on Days 1-5>
  • filgrastim or pegfilgrastim as defined in the protocol> Required ancillary medications is administered during all cycles as defined in the protocol.> Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6.
Overall Number of Participants Analyzed 241 250
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2-year PFS
78.9
(73.8 to 84.2)
75.5
(70.2 to 81.1)
5-year PFS
68.0
(62.1 to 74.5)
66.0
(60.2 to 72.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm B - DA-EPOCH-R, Arm A - R-CHOP
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6519
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.68 to 1.27
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Response Rate
Hide Description The overall response rate is defined as the percentage of participants with a response (Complete Response or Partial Response)
Time Frame Up to 5 years post-registration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm B - DA-EPOCH-R Arm A - R-CHOP
Hide Arm/Group Description:

Patients receive the following treatment:> Cycle 1 Doses:>

  • Rituximab 375 mg/m^2 IV infusion on Day 1 prior to EPOCH chemotherapy>
  • Doxorubicin 10 mg/m^2/day CIVI on Days 1-4>
  • Etoposide 50 mg/m^2/day CIVI on Days 1-4>
  • Vincristine 0.4 mg/m^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours)>
  • Cyclophosphamide 750 mg/m^2 IV on Day 5 (following completion of 96 hour infusions)>
  • Prednisone 60 mg/m^2 PO BID on Days 1-5>
  • Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC > 5000 after the > nadir (nadir usually between Days 10-12) or for 10 days (Days 6-15) if the ANC is not > being monitored, during every cycle.> Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle.> Required ancillary medications are administered during all cycles as defined in the protocol.> Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6.

Patients receive the following treatment:>

  • Rituximab 375 mg/m^2 IV infusion on Day 1 prior to CHOP chemotherapy>
  • Cyclophosphamide 750 mg/m^2 IV on Day 1>
  • Doxorubicin 50 mg/m^2 IV on Day 1>
  • Vincristine 1.4 mg/m^2 IV (2 mg cap) on Day 1>
  • Prednisone 40 mg/m^2/day PO on Days 1-5>
  • filgrastim or pegfilgrastim as defined in the protocol> Required ancillary medications is administered during all cycles as defined in the protocol.> Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6.
Overall Number of Participants Analyzed 241 250
Measure Type: Number
Unit of Measure: percentage of participants
86.7 88.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm B - DA-EPOCH-R, Arm A - R-CHOP
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival Rate at 2 and 5 Years
Hide Description Overall survival is defined as the time from randomization to death due to any cause. The overall survival (OS) rate (percentage of participants who are still alive) at 2 and 5 years Kaplan Meier estimates and 95% confidence intervals are reported below.
Time Frame Up to 5 years post-registration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm B - DA-EPOCH-R Arm A - R-CHOP
Hide Arm/Group Description:

Patients receive the following treatment:> Cycle 1 Doses:>

  • Rituximab 375 mg/m^2 IV infusion on Day 1 prior to EPOCH chemotherapy>
  • Doxorubicin 10 mg/m^2/day CIVI on Days 1-4>
  • Etoposide 50 mg/m^2/day CIVI on Days 1-4>
  • Vincristine 0.4 mg/m^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours)>
  • Cyclophosphamide 750 mg/m^2 IV on Day 5 (following completion of 96 hour infusions)>
  • Prednisone 60 mg/m^2 PO BID on Days 1-5>
  • Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC > 5000 after the > nadir (nadir usually between Days 10-12) or for 10 days (Days 6-15) if the ANC is not > being monitored, during every cycle.> Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle.> Required ancillary medications are administered during all cycles as defined in the protocol.> Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6.

Patients receive the following treatment:>

  • Rituximab 375 mg/m^2 IV infusion on Day 1 prior to CHOP chemotherapy>
  • Cyclophosphamide 750 mg/m^2 IV on Day 1>
  • Doxorubicin 50 mg/m^2 IV on Day 1>
  • Vincristine 1.4 mg/m^2 IV (2 mg cap) on Day 1>
  • Prednisone 40 mg/m^2/day PO on Days 1-5>
  • filgrastim or pegfilgrastim as defined in the protocol> Required ancillary medications is administered during all cycles as defined in the protocol.> Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6.
Overall Number of Participants Analyzed 241 250
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2-year OS rate
86.5
(82.3 to 91.0)
85.7
(81.4 to 90.2)
5-year OS rate
77.5
(72.2 to 83.2)
78.5
(73.4 to 83.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm B - DA-EPOCH-R, Arm A - R-CHOP
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6414
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.75 to 1.59
Estimation Comments [Not Specified]
4.Other Pre-specified Outcome
Title Whether the Gene Expression Signatures That Were Previously Associated With Survival Following CHOP Therapy Are Associated With Survival in Either of the Treatment Arms of the Prospective Trial
Hide Description [Not Specified]
Time Frame Up to 5 years post-registration
Outcome Measure Data Not Reported
Time Frame Up to 5 years
Adverse Event Reporting Description All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
 
Arm/Group Title Arm A - R-CHOP Arm B - DA-EPOCH-R
Hide Arm/Group Description Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6. Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6.
All-Cause Mortality
Arm A - R-CHOP Arm B - DA-EPOCH-R
Affected / at Risk (%) Affected / at Risk (%)
Total   53/250 (21.20%)      56/241 (23.24%)    
Hide Serious Adverse Events
Arm A - R-CHOP Arm B - DA-EPOCH-R
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   232/243 (95.47%)      214/237 (90.30%)    
Blood and lymphatic system disorders     
Febrile neutropenia  1  23/243 (9.47%)  26 43/237 (18.14%)  64
Hemoglobin decreased  1  193/243 (79.42%)  488 201/237 (84.81%)  564
Spleen disorder  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Cardiac disorders     
Atrial fibrillation  1  0/243 (0.00%)  0 2/237 (0.84%)  2
Cardiac disorder  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Left ventricular failure  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Myocardial ischemia  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Palpitations  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Sinus bradycardia  1  0/243 (0.00%)  0 2/237 (0.84%)  5
Sinus tachycardia  1  1/243 (0.41%)  2 2/237 (0.84%)  2
Ear and labyrinth disorders     
Ear disorder  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Hearing impaired  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Eye disorders     
Extraocular muscle paresis  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Eye disorder  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Photophobia  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Vision blurred  1  2/243 (0.82%)  2 3/237 (1.27%)  4
Gastrointestinal disorders     
Abdominal pain  1  8/243 (3.29%)  8 11/237 (4.64%)  17
Anal mucositis (clin exam)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Ascites  1  1/243 (0.41%)  2 0/237 (0.00%)  0
Colonic hemorrhage  1  0/243 (0.00%)  0 1/237 (0.42%)  2
Constipation  1  84/243 (34.57%)  128 81/237 (34.18%)  119
Diarrhea  1  13/243 (5.35%)  19 14/237 (5.91%)  14
Dry mouth  1  3/243 (1.23%)  3 1/237 (0.42%)  1
Dyspepsia  1  4/243 (1.65%)  4 4/237 (1.69%)  5
Esophageal mucositis (clin exam)  1  2/243 (0.82%)  2 0/237 (0.00%)  0
Esophageal pain  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Gastritis  1  1/243 (0.41%)  2 3/237 (1.27%)  7
Gastrointestinal disorder  1  2/243 (0.82%)  2 0/237 (0.00%)  0
Hemorrhoids  1  1/243 (0.41%)  1 2/237 (0.84%)  2
Ileus  1  1/243 (0.41%)  1 2/237 (0.84%)  2
Mucositis oral (clin exam)  1  13/243 (5.35%)  18 23/237 (9.70%)  28
Mucositis oral (funct/sympt)  1  18/243 (7.41%)  31 32/237 (13.50%)  55
Nausea  1  21/243 (8.64%)  33 15/237 (6.33%)  25
Oral hemorrhage  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Oral pain  1  0/243 (0.00%)  0 3/237 (1.27%)  3
Periodontal disease  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Rectal hemorrhage  1  0/243 (0.00%)  0 3/237 (1.27%)  3
Rectal pain  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Stomach pain  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Tooth disorder  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Toothache  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Vomiting  1  8/243 (3.29%)  9 7/237 (2.95%)  9
General disorders     
Chest pain  1  1/243 (0.41%)  1 2/237 (0.84%)  2
Chills  1  2/243 (0.82%)  2 3/237 (1.27%)  3
Death NOS  1  3/243 (1.23%)  3 1/237 (0.42%)  1
Disease progression  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Edema limbs  1  7/243 (2.88%)  9 9/237 (3.80%)  12
Fatigue  1  27/243 (11.11%)  41 41/237 (17.30%)  60
Fever  1  6/243 (2.47%)  6 2/237 (0.84%)  2
Gait abnormal  1  0/243 (0.00%)  0 1/237 (0.42%)  1
General symptom  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Localized edema  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Multi-organ failure  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Pain  1  2/243 (0.82%)  2 2/237 (0.84%)  2
Sudden death  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Hepatobiliary disorders     
Gallbladder pain  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Immune system disorders     
Hypersensitivity  1  15/243 (6.17%)  18 9/237 (3.80%)  9
Immune system disorder  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Infections and infestations     
Abdominal infection(gr 3/4 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Anorectal infection(gr 3/4 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Bladder infection(gr 0/1/2 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Bladder infection(gr 3/4 ANC)  1  0/243 (0.00%)  0 2/237 (0.84%)  3
Bronchitis(gr 0/1/2 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Bronchitis(gr 3/4 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Catheter related infection  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Catheter related infection(gr 3/4 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Colitis, infectious  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Device related infection(gr 3/4 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Esophageal infection(gr 0/1/2 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Esophageal infection(gr 3/4 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Gingival infection(gr 0/1/2 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Gingival infection(gr 3/4 ANC)  1  0/243 (0.00%)  0 3/237 (1.27%)  3
Infection(gr 0/1/2 ANC)  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Infectious colitis(gr 3/4 ANC)  1  0/243 (0.00%)  0 2/237 (0.84%)  4
Nail infection(gr 0/1/2 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Opportunistic infection  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Otitis externa(gr 3/4 ANC)  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Otitis media(gr 3/4 ANC)  1  2/243 (0.82%)  2 0/237 (0.00%)  0
Paranasal sinus infection(gr 0/1/2 ANC)  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Pneumonia(gr 3/4 ANC)  1  0/243 (0.00%)  0 3/237 (1.27%)  4
Pneumonia(unknown ANC)  1  2/243 (0.82%)  2 1/237 (0.42%)  1
Rhinitis infective  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Sepsis(gr 3/4 ANC)  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Sepsis(unknown ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Sinusitis(gr 0/1/2 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Sinusitis(gr 3/4 ANC)  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Skin infection  1  1/243 (0.41%)  1 2/237 (0.84%)  2
Skin infection(gr 3/4 ANC)  1  2/243 (0.82%)  2 1/237 (0.42%)  1
Tooth infection(gr 3/4 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Upper respiratory infection(gr 3/4 ANC)  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Upper respiratory infectn(gr 0/1/2 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Urinary tract infection(gr 0/1/2 ANC)  1  1/243 (0.41%)  1 1/237 (0.42%)  2
Urinary tract infection(gr 3/4 ANC)  1  1/243 (0.41%)  1 2/237 (0.84%)  3
Vaginal infection(gr 0/1/2 ANC)  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Wound infection  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Wound infection(gr 0/1/2 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Injury, poisoning and procedural complications     
Bruising  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Fracture  1  1/243 (0.41%)  1 2/237 (0.84%)  2
Thermal burn  1  0/243 (0.00%)  0 1/237 (0.42%)  2
Vascular access complication  1  4/243 (1.65%)  4 4/237 (1.69%)  4
Wound dehiscence  1  0/243 (0.00%)  0 2/237 (0.84%)  2
Investigations     
Activated partial throm time prolonged  1  1/243 (0.41%)  2 1/237 (0.42%)  2
Alanine aminotransferase increased  1  5/243 (2.06%)  6 7/237 (2.95%)  10
Alkaline phosphatase increased  1  0/243 (0.00%)  0 6/237 (2.53%)  18
Aspartate aminotransferase increased  1  8/243 (3.29%)  10 5/237 (2.11%)  6
Blood bilirubin increased  1  1/243 (0.41%)  1 4/237 (1.69%)  7
CD4 lymphocytes decreased  1  1/243 (0.41%)  4 2/237 (0.84%)  3
Creatinine increased  1  3/243 (1.23%)  6 5/237 (2.11%)  8
Gamma-glutamyltransferase increased  1  0/243 (0.00%)  0 4/237 (1.69%)  7
INR increased  1  0/243 (0.00%)  0 1/237 (0.42%)  2
Laboratory test abnormal  1  2/243 (0.82%)  3 2/237 (0.84%)  2
Leukocyte count decreased  1  72/243 (29.63%)  117 105/237 (44.30%)  242
Lymphocyte count decreased  1  60/243 (24.69%)  114 86/237 (36.29%)  231
Neutrophil count decreased  1  179/243 (73.66%)  331 190/237 (80.17%)  506
Platelet count decreased  1  97/243 (39.92%)  182 184/237 (77.64%)  479
Serum cholesterol increased  1  1/243 (0.41%)  3 0/237 (0.00%)  0
Weight loss  1  4/243 (1.65%)  5 1/237 (0.42%)  1
Metabolism and nutrition disorders     
Anorexia  1  8/243 (3.29%)  9 14/237 (5.91%)  17
Blood glucose increased  1  20/243 (8.23%)  37 25/237 (10.55%)  39
Blood uric acid increased  1  1/243 (0.41%)  3 2/237 (0.84%)  2
Dehydration  1  22/243 (9.05%)  24 19/237 (8.02%)  22
Glucose intolerance  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Serum albumin decreased  1  3/243 (1.23%)  4 12/237 (5.06%)  19
Serum calcium decreased  1  4/243 (1.65%)  4 15/237 (6.33%)  28
Serum calcium increased  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Serum glucose decreased  1  0/243 (0.00%)  0 5/237 (2.11%)  10
Serum magnesium decreased  1  4/243 (1.65%)  4 4/237 (1.69%)  4
Serum magnesium increased  1  0/243 (0.00%)  0 5/237 (2.11%)  11
Serum phosphate decreased  1  5/243 (2.06%)  5 12/237 (5.06%)  14
Serum potassium decreased  1  5/243 (2.06%)  6 29/237 (12.24%)  44
Serum potassium increased  1  2/243 (0.82%)  3 1/237 (0.42%)  1
Serum sodium decreased  1  5/243 (2.06%)  5 6/237 (2.53%)  7
Serum sodium increased  1  0/243 (0.00%)  0 3/237 (1.27%)  5
Serum triglycerides increased  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Tumor lysis syndrome  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  5/243 (2.06%)  5 8/237 (3.38%)  9
Arthritis  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Back pain  1  6/243 (2.47%)  7 5/237 (2.11%)  5
Bone pain  1  4/243 (1.65%)  5 17/237 (7.17%)  28
Chest wall pain  1  0/243 (0.00%)  0 3/237 (1.27%)  3
Muscle weakness  1  1/243 (0.41%)  2 5/237 (2.11%)  6
Muscle weakness lower limb  1  2/243 (0.82%)  2 2/237 (0.84%)  2
Musculoskeletal disorder  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Myalgia  1  6/243 (2.47%)  8 3/237 (1.27%)  5
Myositis  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Neck pain  1  1/243 (0.41%)  1 2/237 (0.84%)  2
Pain in extremity  1  6/243 (2.47%)  7 3/237 (1.27%)  4
Nervous system disorders     
Arachnoiditis  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Ataxia  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Cognitive disturbance  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Depressed level of consciousness  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Dizziness  1  10/243 (4.12%)  11 8/237 (3.38%)  10
Dysgeusia  1  4/243 (1.65%)  6 4/237 (1.69%)  7
Encephalopathy  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Extrapyramidal disorder  1  1/243 (0.41%)  2 0/237 (0.00%)  0
Headache  1  6/243 (2.47%)  8 14/237 (5.91%)  15
Intracranial hemorrhage  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Neuralgia  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Neurological disorder NOS  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Peripheral motor neuropathy  1  23/243 (9.47%)  31 36/237 (15.19%)  62
Peripheral sensory neuropathy  1  104/243 (42.80%)  186 141/237 (59.49%)  322
Syncope  1  2/243 (0.82%)  2 2/237 (0.84%)  2
Tremor  1  2/243 (0.82%)  2 1/237 (0.42%)  1
Psychiatric disorders     
Agitation  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Anxiety  1  2/243 (0.82%)  4 5/237 (2.11%)  7
Confusion  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Depression  1  5/243 (2.06%)  8 7/237 (2.95%)  9
Insomnia  1  8/243 (3.29%)  11 5/237 (2.11%)  6
Libido decreased  1  0/243 (0.00%)  0 1/237 (0.42%)  2
Psychosis  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Renal and urinary disorders     
Cystitis  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Kidney pain  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Renal failure  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Urinary frequency  1  2/243 (0.82%)  2 1/237 (0.42%)  1
Urinary retention  1  0/243 (0.00%)  0 2/237 (0.84%)  2
Reproductive system and breast disorders     
Erectile dysfunction  1  1/243 (0.41%)  1 1/237 (0.42%)  2
Gynecomastia  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Pelvic pain  1  1/243 (0.41%)  2 0/237 (0.00%)  0
Testicular hemorrhage  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Vaginal hemorrhage  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  3/243 (1.23%)  3 4/237 (1.69%)  6
Cough  1  6/243 (2.47%)  7 9/237 (3.80%)  12
Dyspnea  1  4/243 (1.65%)  4 11/237 (4.64%)  17
Nasal congestion  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Pharyngeal mucositis (funct/sympt)  1  0/243 (0.00%)  0 1/237 (0.42%)  2
Pharyngeal stenosis  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Pharyngolaryngeal pain  1  3/243 (1.23%)  3 1/237 (0.42%)  2
Pleural effusion  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Pneumonitis  1  2/243 (0.82%)  3 0/237 (0.00%)  0
Respiratory disorder  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Voice alteration  1  0/243 (0.00%)  0 2/237 (0.84%)  2
Skin and subcutaneous tissue disorders     
Alopecia  1  13/243 (5.35%)  23 8/237 (3.38%)  19
Body odor  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Decubitus ulcer  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Dry skin  1  0/243 (0.00%)  0 2/237 (0.84%)  2
Hand-and-foot syndrome/reaction  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Nail disorder  1  0/243 (0.00%)  0 4/237 (1.69%)  4
Pruritus  1  1/243 (0.41%)  1 2/237 (0.84%)  2
Rash desquamating  1  3/243 (1.23%)  3 4/237 (1.69%)  4
Skin disorder  1  2/243 (0.82%)  2 1/237 (0.42%)  2
Skin hyperpigmentation  1  1/243 (0.41%)  1 2/237 (0.84%)  4
Skin ulceration  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Sweating  1  6/243 (2.47%)  8 0/237 (0.00%)  0
Vascular disorders     
Flushing  1  0/243 (0.00%)  0 2/237 (0.84%)  2
Hemorrhage  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Hot flashes  1  1/243 (0.41%)  2 0/237 (0.00%)  0
Hypertension  1  2/243 (0.82%)  4 9/237 (3.80%)  12
Hypotension  1  0/243 (0.00%)  0 7/237 (2.95%)  11
Thrombosis  1  6/243 (2.47%)  6 4/237 (1.69%)  5
Vascular disorder  1  2/243 (0.82%)  2 0/237 (0.00%)  0
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A - R-CHOP Arm B - DA-EPOCH-R
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   94/243 (38.68%)      119/237 (50.21%)    
Blood and lymphatic system disorders     
Blood disorder  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Febrile neutropenia  1  26/243 (10.70%)  27 44/237 (18.57%)  57
Hemoglobin decreased  1  80/243 (32.92%)  126 116/237 (48.95%)  199
Lymphatic disorder  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Cardiac disorders     
Asystole  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Atrial fibrillation  1  4/243 (1.65%)  5 6/237 (2.53%)  7
Atrial flutter  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Atrial tachycardia  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Cardiac disorder  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Cardiopulmonary arrest  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Left ventricular dysfunction  1  2/243 (0.82%)  2 0/237 (0.00%)  0
Left ventricular failure  1  6/243 (2.47%)  6 3/237 (1.27%)  3
Myocardial ischemia  1  2/243 (0.82%)  2 0/237 (0.00%)  0
Sinus bradycardia  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Sinus tachycardia  1  1/243 (0.41%)  1 7/237 (2.95%)  7
Ear and labyrinth disorders     
Ear pain  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Hearing impaired  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Endocrine disorders     
Adrenal insufficiency  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Gastrointestinal disorders     
Abdominal pain  1  10/243 (4.12%)  11 8/237 (3.38%)  9
Ascites  1  2/243 (0.82%)  2 1/237 (0.42%)  1
Colitis  1  1/243 (0.41%)  2 1/237 (0.42%)  1
Colonic hemorrhage  1  0/243 (0.00%)  0 1/237 (0.42%)  2
Constipation  1  18/243 (7.41%)  20 35/237 (14.77%)  45
Diarrhea  1  8/243 (3.29%)  9 14/237 (5.91%)  15
Duodenal hemorrhage  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Duodenal stenosis  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Dyspepsia  1  2/243 (0.82%)  2 1/237 (0.42%)  1
Dysphagia  1  1/243 (0.41%)  1 7/237 (2.95%)  7
Esophagitis  1  0/243 (0.00%)  0 2/237 (0.84%)  3
Fecal incontinence  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Gastric hemorrhage  1  1/243 (0.41%)  1 2/237 (0.84%)  2
Gastric perforation  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Gastritis  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Ileal perforation  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Ileus  1  4/243 (1.65%)  4 5/237 (2.11%)  6
Jejunal obstruction  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Lower gastrointestinal hemorrhage  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Malabsorption  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Mucositis oral (clin exam)  1  3/243 (1.23%)  4 13/237 (5.49%)  19
Mucositis oral (funct/sympt)  1  5/243 (2.06%)  5 17/237 (7.17%)  21
Nausea  1  9/243 (3.70%)  9 13/237 (5.49%)  15
Oral pain  1  0/243 (0.00%)  0 3/237 (1.27%)  3
Periodontal disease  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Small intestinal obstruction  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Small intestinal perforation  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Small intestinal stenosis  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Upper gastrointestinal hemorrhage  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Vomiting  1  6/243 (2.47%)  6 11/237 (4.64%)  12
General disorders     
Chest pain  1  1/243 (0.41%)  1 4/237 (1.69%)  4
Chills  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Edema limbs  1  10/243 (4.12%)  11 6/237 (2.53%)  6
Fatigue  1  14/243 (5.76%)  17 20/237 (8.44%)  23
Fever  1  3/243 (1.23%)  3 2/237 (0.84%)  2
Hypothermia  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Ill-defined disorder  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Pain  1  0/243 (0.00%)  0 3/237 (1.27%)  3
Visceral edema  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Hepatobiliary disorders     
Gallbladder obstruction  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Gallbladder pain  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Immune system disorders     
Cytokine release syndrome  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Hypersensitivity  1  2/243 (0.82%)  2 5/237 (2.11%)  5
Immune system disorder  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Infections and infestations     
Abdominal infection  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Abdominal infection(unknown ANC)  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Anorectal infection(gr 0/1/2 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Appendicitis perforated  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Bladder infection(gr 0/1/2 ANC)  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Bladder infection(gr 3/4 ANC)  1  0/243 (0.00%)  0 2/237 (0.84%)  2
Bronchitis(gr 3/4 ANC)  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Catheter related infection  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Catheter related infection(gr 0/1/2 ANC)  1  2/243 (0.82%)  2 1/237 (0.42%)  1
Catheter related infection(gr 3/4 ANC)  1  4/243 (1.65%)  4 4/237 (1.69%)  4
Colitis, infectious  1  1/243 (0.41%)  1 2/237 (0.84%)  3
Esophageal infection(unknown ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Gingival infection(gr 3/4 ANC)  1  0/243 (0.00%)  0 2/237 (0.84%)  2
Infection(gr 0/1/2 ANC)  1  2/243 (0.82%)  3 6/237 (2.53%)  6
Infectious colitis(gr 0/1/2 ANC)  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Infectious colitis(gr 3/4 ANC)  1  0/243 (0.00%)  0 2/237 (0.84%)  3
Lip infection(gr 3/4 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Lymph gland infection(gr 3/4 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Mucosal infection(gr 3/4 ANC)  1  0/243 (0.00%)  0 2/237 (0.84%)  2
Opportunistic infection  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Pancreas infection(gr 3/4 ANC)  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Peritoneal infection(gr 3/4 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Pneumonia(gr 0/1/2 ANC)  1  3/243 (1.23%)  3 0/237 (0.00%)  0
Pneumonia(gr 3/4 ANC)  1  4/243 (1.65%)  4 5/237 (2.11%)  5
Pneumonia(unknown ANC)  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Sepsis(gr 0/1/2 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Sepsis(gr 3/4 ANC)  1  2/243 (0.82%)  2 3/237 (1.27%)  4
Sepsis(unknown ANC)  1  0/243 (0.00%)  0 3/237 (1.27%)  3
Skin infection  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Skin infection(gr 3/4 ANC)  1  2/243 (0.82%)  2 1/237 (0.42%)  1
Tooth infection(gr 3/4 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Upper respiratory infection(gr 3/4 ANC)  1  3/243 (1.23%)  3 0/237 (0.00%)  0
Upper respiratory infectn(gr 0/1/2 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Urinary tract infection(gr 0/1/2 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Urinary tract infection(gr 3/4 ANC)  1  3/243 (1.23%)  3 5/237 (2.11%)  6
Vaginal infection(gr 0/1/2 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Vaginal infection(gr 3/4 ANC)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Wound infection  1  0/243 (0.00%)  0 2/237 (0.84%)  2
Wound infection(gr 0/1/2 ANC)  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Wound infection(gr 3/4 ANC)  1  2/243 (0.82%)  2 1/237 (0.42%)  1
Injury, poisoning and procedural complications     
Bruising  1  0/243 (0.00%)  0 2/237 (0.84%)  2
Fracture  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Intraop. inj. - Spinal cord  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Thermal burn  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Vascular access complication  1  1/243 (0.41%)  1 3/237 (1.27%)  4
Venous injury - Viscera  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Wound dehiscence  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Investigations     
Activated partial throm time prolonged  1  0/243 (0.00%)  0 4/237 (1.69%)  4
Alanine aminotransferase increased  1  3/243 (1.23%)  3 6/237 (2.53%)  6
Alkaline phosphatase increased  1  2/243 (0.82%)  2 5/237 (2.11%)  5
Aspartate aminotransferase increased  1  3/243 (1.23%)  3 4/237 (1.69%)  4
Blood bilirubin increased  1  4/243 (1.65%)  4 4/237 (1.69%)  5
CD4 lymphocytes decreased  1  1/243 (0.41%)  1 2/237 (0.84%)  3
Cardiac troponin T increased  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Creatine phosphokinase increased  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Creatinine increased  1  1/243 (0.41%)  2 3/237 (1.27%)  3
Leukocyte count decreased  1  42/243 (17.28%)  58 66/237 (27.85%)  106
Lipase increased  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Lymphocyte count decreased  1  34/243 (13.99%)  52 51/237 (21.52%)  93
Neutrophil count decreased  1  74/243 (30.45%)  109 107/237 (45.15%)  169
Platelet count decreased  1  53/243 (21.81%)  73 107/237 (45.15%)  167
Serum cholesterol increased  1  1/243 (0.41%)  1 4/237 (1.69%)  6
Weight loss  1  4/243 (1.65%)  4 4/237 (1.69%)  4
Metabolism and nutrition disorders     
Acidosis  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Alkalosis  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Anorexia  1  7/243 (2.88%)  7 5/237 (2.11%)  6
Blood glucose increased  1  12/243 (4.94%)  13 13/237 (5.49%)  18
Blood uric acid increased  1  2/243 (0.82%)  2 3/237 (1.27%)  5
Dehydration  1  16/243 (6.58%)  18 21/237 (8.86%)  28
Serum albumin decreased  1  8/243 (3.29%)  10 19/237 (8.02%)  23
Serum calcium decreased  1  7/243 (2.88%)  8 16/237 (6.75%)  20
Serum calcium increased  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Serum glucose decreased  1  1/243 (0.41%)  1 3/237 (1.27%)  3
Serum magnesium decreased  1  1/243 (0.41%)  1 4/237 (1.69%)  4
Serum magnesium increased  1  1/243 (0.41%)  1 4/237 (1.69%)  4
Serum phosphate decreased  1  5/243 (2.06%)  6 11/237 (4.64%)  14
Serum potassium decreased  1  5/243 (2.06%)  5 23/237 (9.70%)  28
Serum potassium increased  1  2/243 (0.82%)  2 2/237 (0.84%)  2
Serum sodium decreased  1  8/243 (3.29%)  8 10/237 (4.22%)  13
Serum sodium increased  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Serum triglycerides increased  1  0/243 (0.00%)  0 1/237 (0.42%)  2
Tumor lysis syndrome  1  2/243 (0.82%)  2 1/237 (0.42%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Back pain  1  3/243 (1.23%)  3 2/237 (0.84%)  2
Bone pain  1  1/243 (0.41%)  1 5/237 (2.11%)  5
Muscle weakness  1  3/243 (1.23%)  3 8/237 (3.38%)  10
Muscle weakness lower limb  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Muscle weakness right-sided  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Musculoskeletal disorder  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Myalgia  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Neck pain  1  0/243 (0.00%)  0 2/237 (0.84%)  2
Neck soft tissue necrosis  1  0/243 (0.00%)  0 1/237 (0.42%)  2
Pain in extremity  1  1/243 (0.41%)  1 3/237 (1.27%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Nervous system disorders     
Cognitive disturbance  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Depressed level of consciousness  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Dizziness  1  5/243 (2.06%)  6 2/237 (0.84%)  2
Dysgeusia  1  2/243 (0.82%)  2 1/237 (0.42%)  1
Encephalopathy  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Headache  1  2/243 (0.82%)  2 2/237 (0.84%)  2
Ischemia cerebrovascular  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Mini mental status examination abnormal  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Neurological disorder NOS  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Peripheral motor neuropathy  1  5/243 (2.06%)  5 16/237 (6.75%)  20
Peripheral sensory neuropathy  1  25/243 (10.29%)  31 68/237 (28.69%)  108
Seizure  1  0/243 (0.00%)  0 3/237 (1.27%)  3
Syncope  1  0/243 (0.00%)  0 3/237 (1.27%)  3
Psychiatric disorders     
Anxiety  1  0/243 (0.00%)  0 3/237 (1.27%)  3
Confusion  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Depression  1  0/243 (0.00%)  0 4/237 (1.69%)  4
Insomnia  1  3/243 (1.23%)  3 4/237 (1.69%)  4
Renal and urinary disorders     
Bladder pain  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Bladder spasm  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Cystitis  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Hemorrhage urinary tract  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Kidney pain  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Proteinuria  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Renal failure  1  4/243 (1.65%)  4 5/237 (2.11%)  5
Urinary frequency  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Urinary retention  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Urogenital disorder  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Reproductive system and breast disorders     
Pelvic pain  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome  1  2/243 (0.82%)  2 0/237 (0.00%)  0
Allergic rhinitis  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Atelectasis  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Cough  1  2/243 (0.82%)  2 4/237 (1.69%)  4
Dyspnea  1  8/243 (3.29%)  10 9/237 (3.80%)  10
Hiccups  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Hypoxia  1  4/243 (1.65%)  4 8/237 (3.38%)  9
Pharyngeal mucositis (clin exam)  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Pharyngolaryngeal pain  1  1/243 (0.41%)  1 2/237 (0.84%)  2
Pleural effusion  1  2/243 (0.82%)  2 2/237 (0.84%)  2
Pneumonitis  1  4/243 (1.65%)  4 3/237 (1.27%)  3
Pneumothorax  1  1/243 (0.41%)  1 0/237 (0.00%)  0
Respiratory disorder  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Voice alteration  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Skin and subcutaneous tissue disorders     
Alopecia  1  4/243 (1.65%)  4 6/237 (2.53%)  6
Decubitus ulcer  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Erythema multiforme  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Nail disorder  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Pruritus  1  0/243 (0.00%)  0 2/237 (0.84%)  2
Rash acneiform  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Rash desquamating  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Skin ulceration  1  2/243 (0.82%)  2 0/237 (0.00%)  0
Sweating  1  1/243 (0.41%)  1 1/237 (0.42%)  1
Vascular disorders     
Flushing  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Hemorrhage  1  0/243 (0.00%)  0 1/237 (0.42%)  1
Hypertension  1  1/243 (0.41%)  1 2/237 (0.84%)  2
Hypotension  1  8/243 (3.29%)  8 13/237 (5.49%)  15
Thrombosis  1  6/243 (2.47%)  6 10/237 (4.22%)  11
Vascular disorder  1  1/243 (0.41%)  1 1/237 (0.42%)  1
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nancy Bartlett, M.D.
Organization: Washington University School of Medicine
Phone: 314-362-5654
EMail: nbartlet@wustl.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00118209    
Obsolete Identifiers: NCT00234351
Other Study ID Numbers: CALGB-50303
CDR0000433265 ( Other Identifier: NCI Physician Data Query )
NCI-2009-00480 ( Registry Identifier: NCI Clinical Trial Reporting Program )
U10CA031946 ( U.S. NIH Grant/Contract )
U10CA180821 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2005
First Posted: July 11, 2005
Results First Submitted: April 6, 2020
Results First Posted: April 17, 2020
Last Update Posted: November 17, 2021