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Phase II Study of Dose-Adjusted EPOCH-Rituximab in Adults With Untreated Burkitt Lymphoma and c-MYC+ Diffuse Large B-Cell 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: NCT01092182
Recruitment Status : Active, not recruiting
First Posted : March 24, 2010
Results First Posted : October 19, 2021
Last Update Posted : November 9, 2022
Sponsor:
Information provided by (Responsible Party):
Mark Roschewski, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Burkitt Lymphoma
Diffuse Large B-cell Lymphoma, c-MYC Positive
Plasmablastic Lymphoma
Interventions Drug: EPOCH-R
Drug: EPOCH-RR
Enrollment 194
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Low-risk Burkitt Lymphoma (BL) High-Risk Burkitt Lymphoma (BL) High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
Hide Arm/Group Description

Burkitt lymphoma Low Risk Arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Burkitt lymphoma High Risk Arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

High-Risk Diffuse Large B Cell Lymphoma

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Period Title: Overall Study
Started 15 98 81
Completed 14 80 53
Not Completed 1 18 28
Reason Not Completed
Death             0             5             3
participant safety             1             2             0
Physician Decision             0             6             0
Did not meet criteria             0             0             25
Non-compliance             0             3             0
Participant refused follow-up             0             2             0
Arm/Group Title Group A - Low-risk Burkitt Lymphoma (BL) Group B - High-Risk Burkitt Lymphoma (BL) Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) Total
Hide Arm/Group Description

Burkitt lymphoma Low Risk Arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Burkitt lymphoma High Risk Arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Diffuse large B-cell lymphoma (DLBCL) high risk arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Total of all reporting groups
Overall Number of Baseline Participants 15 98 81 194
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 98 participants 81 participants 194 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
  86.7%
84
  85.7%
55
  67.9%
152
  78.4%
>=65 years
2
  13.3%
14
  14.3%
26
  32.1%
42
  21.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 98 participants 81 participants 194 participants
51.47  (14.85) 46.35  (17.53) 57.47  (14) 51.39  (16.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 98 participants 81 participants 194 participants
Female
4
  26.7%
20
  20.4%
20
  24.7%
44
  22.7%
Male
11
  73.3%
78
  79.6%
61
  75.3%
150
  77.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 98 participants 81 participants 194 participants
Black or African American
2
  13.3%
16
  16.3%
6
   7.4%
24
  12.4%
White
11
  73.3%
65
  66.3%
66
  81.5%
142
  73.2%
Indian or Alaska Native
1
   6.7%
0
   0.0%
0
   0.0%
1
   0.5%
Indian or Alaska Native + White
0
   0.0%
1
   1.0%
0
   0.0%
1
   0.5%
Asian
1
   6.7%
5
   5.1%
2
   2.5%
8
   4.1%
Race Unknown/Not Reported
0
   0.0%
11
  11.2%
7
   8.6%
18
   9.3%
Hispanic or Latino
1
   6.7%
10
  10.2%
4
   4.9%
15
   7.7%
Not Hispanic or Latino
14
  93.3%
80
  81.6%
72
  88.9%
166
  85.6%
Ethnicity Unknown/Not Reported
0
   0.0%
8
   8.2%
5
   6.2%
13
   6.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 98 participants 81 participants 194 participants
15 98 81 194
Eastern Cooperative Oncology Group (ECOG)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 98 participants 81 participants 194 participants
0
11
  73.3%
39
  39.8%
26
  32.1%
76
  39.2%
1
4
  26.7%
38
  38.8%
37
  45.7%
79
  40.7%
2
0
   0.0%
14
  14.3%
9
  11.1%
23
  11.9%
3
0
   0.0%
4
   4.1%
7
   8.6%
11
   5.7%
4
0
   0.0%
3
   3.1%
2
   2.5%
5
   2.6%
[1]
Measure Description:

ECOG Criteria:

0 - Normal activity

  1. - Symptoms, but ambulatory.
  2. - In bed <50% of the time.
  3. - In bed >50% of the time.
  4. - 100% bedridden.
Baseline Risk Stratification   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 98 participants 81 participants 194 participants
Low Risk
15
 100.0%
0
   0.0%
0
   0.0%
15
   7.7%
High Risk
0
   0.0%
98
 100.0%
81
 100.0%
179
  92.3%
[1]
Measure Description: Low Risk disease High Risk disease
International Prognostic Index Score 0-5   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 98 participants 81 participants 194 participants
0
12
  80.0%
8
   8.2%
7
   8.6%
27
  13.9%
1
3
  20.0%
19
  19.4%
7
   8.6%
29
  14.9%
2
0
   0.0%
20
  20.4%
28
  34.6%
48
  24.7%
3
0
   0.0%
24
  24.5%
30
  37.0%
54
  27.8%
4
0
   0.0%
24
  24.5%
5
   6.2%
29
  14.9%
5
0
   0.0%
3
   3.1%
4
   4.9%
7
   3.6%
[1]
Measure Description: International Prognostic Index Score 0 -1 is low risk 2 is low-intermediate risk 3 is high-intermediate risk 4 - 5 is high risk
Histology  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 98 participants 81 participants 194 participants
High Grade B Cell Lymphoma Double-hit (HGBL DH) NA [1]  NA [1] 
24
  29.6%
NA [2] 
High Grade B Cell Lymphoma Not Otherwise Specified (HGBL NOS) NA [1]  NA [1] 
12
  14.8%
NA [2] 
Diffuse Large B-Cell Lymphoma (DLBCL) NA [1]  NA [1] 
44
  54.3%
NA [2] 
Plasmablastic NA [1]  NA [1] 
1
   1.2%
NA [2] 
[1]
This study specific measure is only applicable to Group C.
[2]
Total not calculated because data are not available (NA) in one or more arms.
1.Primary Outcome
Title Percentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval
Hide Description PFS is the time interval from start of treatment to documented evidence of disease progression. Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval.
Time Frame Time of progression or death at 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Those participants that were not analyzed for PFS were screen failures (did not have MYC+ Diffuse Large B-Cell Lymphoma (DLBCL).
Arm/Group Title Group A - Low-risk Burkitt Lymphoma (BL) Group B - High-Risk Burkitt Lymphoma (BL) Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
Hide Arm/Group Description:

Burkitt lymphoma Low Risk Arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Burkitt lymphoma High Risk Arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Diffuse large B-cell lymphoma (DLBCL) high risk arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Overall Number of Participants Analyzed 15 98 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100
(1 to 100)
82.1
(72.7 to 88.5)
71.0
(56.5 to 81.4)
2.Primary Outcome
Title Percentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval
Hide Description EFS was determined from the date of enrolment in the study until the date of progression, last documentation of disease at or after the last treatment cycle, death, or last follow-up (whichever occurred first). Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval.
Time Frame At 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Those participants that were not analyzed for EFS were screen failures (did not have MYC+ Diffuse Large B-Cell Lymphoma (DLBCL).
Arm/Group Title Group A - Low-risk Burkitt Lymphoma (BL) Group B - High-Risk Burkitt Lymphoma (BL) Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
Hide Arm/Group Description:

Burkitt lymphoma Low Risk Arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Burkitt lymphoma High Risk Arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Diffuse large B-cell lymphoma (DLBCL) high risk arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Overall Number of Participants Analyzed 15 98 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100
(1 to 100)
82.1
(72.7 to 88.5)
71.0
(58.5 to 81.4)
3.Primary Outcome
Title Percentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval
Hide Description OS was calculated from the enrolment date until date of death or last follow-up using the Kaplan Meier. Kaplan-Meier curves were constructed with an 95% confidence interval.
Time Frame At 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Those participants that were not analyzed for OS were screen failures (did not have MYC+ Diffuse Large B-Cell Lymphoma (DLBCL).
Arm/Group Title Group A - Low-risk Burkitt Lymphoma (BL) Group B - High-Risk Burkitt Lymphoma (BL) Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
Hide Arm/Group Description:

Burkitt lymphoma Low Risk Arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Burkitt lymphoma High Risk Arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Diffuse large B-cell lymphoma (DLBCL) high risk arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Overall Number of Participants Analyzed 15 98 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100
(1 to 100)
84.9
(75.8 to 90.8)
76.7
(62.6 to 86.1)
4.Secondary Outcome
Title Kaplan-Meier Progression Free Survival (PFS) Constructed With an 95% Confidence Interval in Participants Who Underwent Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) and/or Computed Tomography (CT) Scans After Cycle 2
Hide Description The predictive value of early FDG-PET/CT scans on PFS was assessed after cycle 2. PFS is the time interval from start of treatment to documented evidence of disease progression, assessed by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval.
Time Frame After 2 cycles of therapy and prior to cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
51/98 participants and 34/81 participants did not receive a PET scan.
Arm/Group Title Group A - Low-risk Burkitt Lymphoma (BL) Group B - High-Risk Burkitt Lymphoma (BL) Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
Hide Arm/Group Description:

Burkitt lymphoma Low Risk Arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Burkitt lymphoma High Risk Arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Diffuse large B-cell lymphoma (DLBCL) high risk arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Overall Number of Participants Analyzed 15 51 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100
(1 to 100)
90.0
(77.7 to 95.7)
78.7
(60.5 to 89.2)
5.Other Pre-specified Outcome
Title Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Hide Description Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Date treatment consent signed to date off study, approximately 102 months and 25 days for Group A, 125 months and 28 days for Group B and 117 months and 29 days for group C.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A - Low-risk Burkitt Lymphoma (BL) Group B - High-Risk Burkitt Lymphoma (BL) Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
Hide Arm/Group Description:

Burkitt lymphoma Low Risk Arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Burkitt lymphoma High Risk Arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Diffuse large B-cell lymphoma (DLBCL) high risk arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Overall Number of Participants Analyzed 15 98 81
Measure Type: Count of Participants
Unit of Measure: Participants
13
  86.7%
87
  88.8%
72
  88.9%
Time Frame Date treatment consent signed to date off study, approximately 102 months and 25 days for Group A, 125 months and 28 days for Group B and 117 months and 29 days for group C.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A - Low-risk Burkitt Lymphoma (BL) Group B - High-Risk Burkitt Lymphoma (BL) Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
Hide Arm/Group Description

Burkitt lymphoma Low Risk Arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Burkitt lymphoma High Risk Arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Diffuse large B-cell lymphoma (DLBCL) high risk arm

Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

All-Cause Mortality
Group A - Low-risk Burkitt Lymphoma (BL) Group B - High-Risk Burkitt Lymphoma (BL) Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      16/98 (16.33%)      3/81 (3.70%)    
Hide Serious Adverse Events
Group A - Low-risk Burkitt Lymphoma (BL) Group B - High-Risk Burkitt Lymphoma (BL) Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/15 (20.00%)      58/98 (59.18%)      33/81 (40.74%)    
Blood and lymphatic system disorders       
Anemia  1  1/15 (6.67%)  2 12/98 (12.24%)  21 4/81 (4.94%)  5
Febrile neutropenia  1  0/15 (0.00%)  0 27/98 (27.55%)  48 11/81 (13.58%)  16
Cardiac disorders       
Atrial fibrillation  1  0/15 (0.00%)  0 1/98 (1.02%)  1 1/81 (1.23%)  1
Cardiac arrest  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Cardiac disorders - Other, hypotension  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Chest pain - cardiac  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Myocardial infarction  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Restrictive cardiomyopathy  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Gastrointestinal disorders       
Abdominal distension  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Abdominal pain  1  0/15 (0.00%)  0 2/98 (2.04%)  3 1/81 (1.23%)  1
Colitis  1  0/15 (0.00%)  0 2/98 (2.04%)  2 1/81 (1.23%)  1
Diarrhea  1  0/15 (0.00%)  0 0/98 (0.00%)  0 2/81 (2.47%)  3
Gastric perforation  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Gastrointestinal disorders - Other, bleeding  1  0/15 (0.00%)  0 2/98 (2.04%)  2 1/81 (1.23%)  1
Ileus  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Jejunal perforation  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Lower gastrointestinal hemorrhage  1  0/15 (0.00%)  0 2/98 (2.04%)  2 1/81 (1.23%)  1
Mucositis oral  1  0/15 (0.00%)  0 8/98 (8.16%)  11 0/81 (0.00%)  0
Nausea  1  0/15 (0.00%)  0 2/98 (2.04%)  2 2/81 (2.47%)  3
Oral pain  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Pancreatitis  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Small intestinal obstruction  1  0/15 (0.00%)  0 1/98 (1.02%)  2 0/81 (0.00%)  0
Vomiting  1  0/15 (0.00%)  0 3/98 (3.06%)  3 2/81 (2.47%)  3
Gastrointestinal disorders - Other, heme positive stool  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Gastrointestinal disorders - Other, odynohagia  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
General disorders       
Death NOS  1  0/15 (0.00%)  0 10/98 (10.20%)  10 9/81 (11.11%)  9
Edema limbs  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Fatigue  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Fever  1  0/15 (0.00%)  0 6/98 (6.12%)  7 1/81 (1.23%)  1
General disorders and administration site conditions - Other, specify  1 [1]  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infusion related reaction  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Multi-organ failure  1  0/15 (0.00%)  0 1/98 (1.02%)  1 2/81 (2.47%)  2
Pain  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations       
Catheter related infection  1  1/15 (6.67%)  1 0/98 (0.00%)  0 0/81 (0.00%)  0
Device related infection  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, cellulitis  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Lung infection  1  0/15 (0.00%)  0 3/98 (3.06%)  3 1/81 (1.23%)  1
Phlebitis infective  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Sepsis  1  0/15 (0.00%)  0 6/98 (6.12%)  6 4/81 (4.94%)  6
Sinusitis  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Skin infection  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, clostridium difficile  1  1/15 (6.67%)  1 0/98 (0.00%)  0 0/81 (0.00%)  0
Infections and infestations - Other, influenza A/H1N1  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, Infected Cholecystostomy tube in setting of neutropenia?  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, neutropenic fever  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, liver infection  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Injury, poisoning and procedural complications       
Vascular access complication  1  0/15 (0.00%)  0 2/98 (2.04%)  2 0/81 (0.00%)  0
Investigations       
Alanine aminotransferase increased  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Aspartate aminotransferase increased  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Ejection fraction decreased  1  0/15 (0.00%)  0 1/98 (1.02%)  1 1/81 (1.23%)  1
Lymphocyte count decreased  1  1/15 (6.67%)  1 7/98 (7.14%)  14 3/81 (3.70%)  7
Neutrophil count decreased  1  1/15 (6.67%)  1 11/98 (11.22%)  26 5/81 (6.17%)  8
Platelet count decreased  1  0/15 (0.00%)  0 6/98 (6.12%)  12 4/81 (4.94%)  6
White blood cell decreased  1  0/15 (0.00%)  0 15/98 (15.31%)  38 5/81 (6.17%)  7
Metabolism and nutrition disorders       
Dehydration  1  0/15 (0.00%)  0 3/98 (3.06%)  3 2/81 (2.47%)  2
Hyperglycemia  1  0/15 (0.00%)  0 2/98 (2.04%)  2 2/81 (2.47%)  2
Hypoalbuminemia  1  0/15 (0.00%)  0 0/98 (0.00%)  0 2/81 (2.47%)  3
Hypocalcemia  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Hypokalemia  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Hyponatremia  1  1/15 (6.67%)  1 3/98 (3.06%)  3 2/81 (2.47%)  2
Hypophosphatemia  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Tumor lysis syndrome  1  0/15 (0.00%)  0 1/98 (1.02%)  1 1/81 (1.23%)  1
Musculoskeletal and connective tissue disorders       
Bone pain  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Myelodysplastic syndrome  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1 [2]  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Treatment related secondary malignancy  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1 [3]  0/15 (0.00%)  0 1/98 (1.02%)  1 1/81 (1.23%)  1
Nervous system disorders       
Cerebrospinal fluid leakage  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Dizziness  1  0/15 (0.00%)  0 1/98 (1.02%)  1 1/81 (1.23%)  1
Headache  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Intracranial hemorrhage  1  0/15 (0.00%)  0 2/98 (2.04%)  2 0/81 (0.00%)  0
Syncope  1  0/15 (0.00%)  0 0/98 (0.00%)  0 4/81 (4.94%)  4
Vasovagal reaction  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Psychiatric disorders       
Hallucinations  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury  1  0/15 (0.00%)  0 1/98 (1.02%)  1 3/81 (3.70%)  4
Hematuria  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Proteinuria  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Renal and urinary disorders - Other, acute kidney injury  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Aspiration  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Bronchopulmonary hemorrhage  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Hypoxia  1  0/15 (0.00%)  0 2/98 (2.04%)  2 0/81 (0.00%)  0
Pneumonitis  1  0/15 (0.00%)  0 1/98 (1.02%)  1 1/81 (1.23%)  1
Respiratory failure  1  0/15 (0.00%)  0 1/98 (1.02%)  1 3/81 (3.70%)  3
Respiratory, thoracic and mediastinal disorders - Other, specify  1 [4]  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Skin and subcutaneous tissue disorders       
Toxic epidermal necrolysis  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Vascular disorders       
Hematoma  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Hypertension  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Hypotension  1  0/15 (0.00%)  0 4/98 (4.08%)  5 2/81 (2.47%)  2
Thromboembolic event  1  0/15 (0.00%)  0 3/98 (3.06%)  3 1/81 (1.23%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Weakness, difficulty swallowing, esophagitis
[2]
Cholangiocarcinoma of liver
[3]
Progressive disease
[4]
Pharyngeal pain
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A - Low-risk Burkitt Lymphoma (BL) Group B - High-Risk Burkitt Lymphoma (BL) Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/15 (86.67%)      88/98 (89.80%)      71/81 (87.65%)    
Blood and lymphatic system disorders       
Anemia  1  6/15 (40.00%)  9 62/98 (63.27%)  216 53/81 (65.43%)  181
Blood and lymphatic system disorders - Other, DVT  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Febrile neutropenia  1  1/15 (6.67%)  1 29/98 (29.59%)  42 22/81 (27.16%)  35
Leukocytosis  1  0/15 (0.00%)  0 3/98 (3.06%)  3 2/81 (2.47%)  2
Blood and lymphatic system disorders - Other, leukopenia  1  0/15 (0.00%)  0 2/98 (2.04%)  4 0/81 (0.00%)  0
Blood and lymphatic system disorders - Other, low ANC  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Blood and lymphatic system disorders - Other, low platelet count  1  0/15 (0.00%)  0 2/98 (2.04%)  2 0/81 (0.00%)  0
Blood and lymphatic system disorders - Other, T bili  1  0/15 (0.00%)  0 0/98 (0.00%)  0 2/81 (2.47%)  2
Blood and lymphatic system disorders - Other, thrombosis/embolism  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Cardiac disorders       
Acute coronary syndrome  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Atrial fibrillation  1  0/15 (0.00%)  0 5/98 (5.10%)  6 2/81 (2.47%)  2
Atrial flutter  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Cardiac disorders - Other, 23% decreased EF  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Chest pain - cardiac  1  1/15 (6.67%)  1 1/98 (1.02%)  1 0/81 (0.00%)  0
Palpitations  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Sinus bradycardia  1  1/15 (6.67%)  1 2/98 (2.04%)  2 0/81 (0.00%)  0
Sinus tachycardia  1  0/15 (0.00%)  0 4/98 (4.08%)  4 4/81 (4.94%)  5
Supraventricular tachycardia  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Ear and labyrinth disorders       
Ear pain  1  0/15 (0.00%)  0 0/98 (0.00%)  0 2/81 (2.47%)  2
Tinnitus  1  0/15 (0.00%)  0 1/98 (1.02%)  1 1/81 (1.23%)  1
Vertigo  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Endocrine disorders       
Adrenal insufficiency  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Eye disorders       
Blurred vision  1  0/15 (0.00%)  0 3/98 (3.06%)  3 2/81 (2.47%)  2
Eyelid function disorder  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Floaters  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Photophobia  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Retinal detachment  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Watering eyes  1  0/15 (0.00%)  0 0/98 (0.00%)  0 2/81 (2.47%)  2
Gastrointestinal disorders       
Abdominal distension  1  0/15 (0.00%)  0 3/98 (3.06%)  3 0/81 (0.00%)  0
Abdominal infection  1  0/15 (0.00%)  0 2/98 (2.04%)  2 0/81 (0.00%)  0
Abdominal pain  1  2/15 (13.33%)  2 8/98 (8.16%)  11 5/81 (6.17%)  5
Anal fistula  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Ascites  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Bloating  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Colitis  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Constipation  1  6/15 (40.00%)  6 20/98 (20.41%)  23 22/81 (27.16%)  37
Diarrhea  1  0/15 (0.00%)  0 18/98 (18.37%)  20 17/81 (20.99%)  22
Dry mouth  1  0/15 (0.00%)  0 0/98 (0.00%)  0 2/81 (2.47%)  2
Dyspepsia  1  0/15 (0.00%)  0 2/98 (2.04%)  3 3/81 (3.70%)  3
Dysphagia  1  0/15 (0.00%)  0 4/98 (4.08%)  4 2/81 (2.47%)  2
Enterocolitis  1  0/15 (0.00%)  0 2/98 (2.04%)  2 0/81 (0.00%)  0
Esophageal hemorrhage  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Esophagitis  1  0/15 (0.00%)  0 2/98 (2.04%)  2 0/81 (0.00%)  0
Fecal incontinence  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Flatulence  1  1/15 (6.67%)  1 0/98 (0.00%)  0 2/81 (2.47%)  2
Gastritis  1  1/15 (6.67%)  1 1/98 (1.02%)  1 2/81 (2.47%)  2
Gastroesophageal reflux disease  1  0/15 (0.00%)  0 2/98 (2.04%)  2 2/81 (2.47%)  2
Gastrointestinal disorders - Other, epigastric pain  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Hemorrhoids  1  0/15 (0.00%)  0 3/98 (3.06%)  3 1/81 (1.23%)  2
Ileus  1  0/15 (0.00%)  0 1/98 (1.02%)  1 3/81 (3.70%)  4
Mucositis oral  1  1/15 (6.67%)  1 23/98 (23.47%)  47 20/81 (24.69%)  31
Nausea  1  1/15 (6.67%)  3 18/98 (18.37%)  25 11/81 (13.58%)  16
Oral hemorrhage  1  1/15 (6.67%)  1 0/98 (0.00%)  0 0/81 (0.00%)  0
Oral pain  1  1/15 (6.67%)  1 1/98 (1.02%)  1 1/81 (1.23%)  5
Rectal hemorrhage  1  0/15 (0.00%)  0 1/98 (1.02%)  1 1/81 (1.23%)  1
Stomach pain  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Toothache  1  1/15 (6.67%)  1 2/98 (2.04%)  2 0/81 (0.00%)  0
Typhlitis  1  0/15 (0.00%)  0 2/98 (2.04%)  2 0/81 (0.00%)  0
Vomiting  1  0/15 (0.00%)  0 9/98 (9.18%)  14 7/81 (8.64%)  8
General disorders       
Chills  1  1/15 (6.67%)  1 5/98 (5.10%)  6 2/81 (2.47%)  2
Death NOS  1  0/15 (0.00%)  0 2/98 (2.04%)  2 1/81 (1.23%)  1
Edema limbs  1  0/15 (0.00%)  0 3/98 (3.06%)  3 11/81 (13.58%)  12
Fatigue  1  4/15 (26.67%)  7 22/98 (22.45%)  28 22/81 (27.16%)  35
Fever  1  1/15 (6.67%)  1 13/98 (13.27%)  16 8/81 (9.88%)  10
Flu like symptoms  1  0/15 (0.00%)  0 1/98 (1.02%)  1 2/81 (2.47%)  2
Gait disturbance  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
General disorders and administration site conditions - Other, cerebellar infarct  1  0/15 (0.00%)  0 2/98 (2.04%)  3 0/81 (0.00%)  0
Infusion related reaction  1  0/15 (0.00%)  0 2/98 (2.04%)  2 3/81 (3.70%)  3
Neck edema  1  0/15 (0.00%)  0 2/98 (2.04%)  2 0/81 (0.00%)  0
Pain  1  1/15 (6.67%)  1 10/98 (10.20%)  14 6/81 (7.41%)  7
General disorders and administration site conditions - Other, sacral pressure ulcer  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
General disorders and administration site conditions - Other, thalmic infarct  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Hepatobiliary disorders       
Hepatic failure  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Immune system disorders       
Allergic reaction  1  0/15 (0.00%)  0 3/98 (3.06%)  3 2/81 (2.47%)  2
Infections and infestations       
Anorectal infection  1  0/15 (0.00%)  0 1/98 (1.02%)  1 1/81 (1.23%)  1
Bladder infection  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Bronchial infection  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Catheter related infection  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Enterocolitis infectious  1  0/15 (0.00%)  0 2/98 (2.04%)  2 4/81 (4.94%)  4
Esophageal infection  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Eye infection  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Infections and infestations - Other, bacteremia  1  1/15 (6.67%)  1 0/98 (0.00%)  0 0/81 (0.00%)  0
Lung infection  1  0/15 (0.00%)  0 1/98 (1.02%)  1 1/81 (1.23%)  1
Mucosal infection  1  0/15 (0.00%)  0 8/98 (8.16%)  12 4/81 (4.94%)  5
Peritoneal infection  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Rhinitis infective  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Sepsis  1  0/15 (0.00%)  0 1/98 (1.02%)  1 2/81 (2.47%)  2
Sinusitis  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Skin infection  1  0/15 (0.00%)  0 2/98 (2.04%)  2 0/81 (0.00%)  0
Upper respiratory infection  1  1/15 (6.67%)  1 0/98 (0.00%)  0 1/81 (1.23%)  1
Urethral infection  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Urinary tract infection  1  0/15 (0.00%)  0 8/98 (8.16%)  9 8/81 (9.88%)  11
Wound infection  1  0/15 (0.00%)  0 1/98 (1.02%)  1 1/81 (1.23%)  1
Infections and infestations - Other, Blood  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, blood infection  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, blood, E. coli  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, bacteremia, Klebsiella infection  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Infections and infestations - Other, candida oral infection  1  0/15 (0.00%)  0 1/98 (1.02%)  2 0/81 (0.00%)  0
Infections and infestations - Other, clostridium difficile  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, CMV reactivation  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Infections and infestations - Other, encephalitis, persistent  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, gastrointestinal tract  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, infection  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Infections and infestations - Other, infection-oral  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, L posterior lung  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, left orbital cellulitis  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, MRSA  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, oral cavity  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, parasitic infection  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, PICC line infection  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, polymicrobial bacteremia  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, throat  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Infections and infestations - Other, thrush  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, VRE  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Infections and infestations - Other, VRE-blood stream  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, blood, candida glabrata  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Infections and infestations - Other, herpes simplex oral ulcer  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Infections and infestations - Other, oral thrush  1  0/15 (0.00%)  0 1/98 (1.02%)  1 1/81 (1.23%)  1
Injury, poisoning and procedural complications       
Bruising  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Fall  1  0/15 (0.00%)  0 2/98 (2.04%)  2 1/81 (1.23%)  1
Investigations       
Activated partial thromboplastin time prolonged  1  0/15 (0.00%)  0 0/98 (0.00%)  0 2/81 (2.47%)  2
Alanine aminotransferase increased  1  2/15 (13.33%)  2 15/98 (15.31%)  23 7/81 (8.64%)  14
Alkaline phosphatase increased  1  0/15 (0.00%)  0 7/98 (7.14%)  10 12/81 (14.81%)  21
Aspartate aminotransferase increased  1  1/15 (6.67%)  1 13/98 (13.27%)  18 7/81 (8.64%)  12
Blood bilirubin increased  1  2/15 (13.33%)  2 9/98 (9.18%)  13 5/81 (6.17%)  9
CD4 lymphocytes decreased  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Cardiac troponin I increased  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Cardiac troponin T increased  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Creatinine increased  1  0/15 (0.00%)  0 1/98 (1.02%)  1 1/81 (1.23%)  1
Elevated LFT's  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Elevated bilirubin  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
GGT increased  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Investigations - Other, disease progression  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Lipase increased  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Lymphocyte count decreased  1  5/15 (33.33%)  11 54/98 (55.10%)  277 49/81 (60.49%)  239
Lymphocyte count increased  1  0/15 (0.00%)  0 1/98 (1.02%)  1 3/81 (3.70%)  3
Neutrophil count decreased  1  5/15 (33.33%)  6 55/98 (56.12%)  201 49/81 (60.49%)  178
Pancreatic enzymes decreased  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Platelet count decreased  1  3/15 (20.00%)  3 52/98 (53.06%)  161 43/81 (53.09%)  159
Urine output decreased  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Weight gain  1  0/15 (0.00%)  0 3/98 (3.06%)  5 1/81 (1.23%)  1
Weight loss  1  0/15 (0.00%)  0 2/98 (2.04%)  2 5/81 (6.17%)  8
White blood cell decreased  1  7/15 (46.67%)  10 47/98 (47.96%)  212 52/81 (64.20%)  218
Investigations - Other, heartburn  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Investigations - Other, night sweats  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Investigations - Other, fluid overload  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Metabolism and nutrition disorders       
Alkalosis  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Anorexia  1  1/15 (6.67%)  1 9/98 (9.18%)  10 6/81 (7.41%)  7
Dehydration  1  0/15 (0.00%)  0 7/98 (7.14%)  11 2/81 (2.47%)  3
Glucose intolerance  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Hypercalcemia  1  0/15 (0.00%)  0 1/98 (1.02%)  1 3/81 (3.70%)  3
Hyperglycemia  1  0/15 (0.00%)  0 16/98 (16.33%)  42 15/81 (18.52%)  37
Hyperkalemia  1  0/15 (0.00%)  0 3/98 (3.06%)  3 3/81 (3.70%)  3
Hypermagnesemia  1  1/15 (6.67%)  1 2/98 (2.04%)  2 3/81 (3.70%)  4
Hypernatremia  1  0/15 (0.00%)  0 4/98 (4.08%)  5 8/81 (9.88%)  17
Hypertriglyceridemia  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Hyperuricemia  1  0/15 (0.00%)  0 1/98 (1.02%)  1 2/81 (2.47%)  2
Hypoalbuminemia  1  0/15 (0.00%)  0 18/98 (18.37%)  32 15/81 (18.52%)  27
Hypocalcemia  1  0/15 (0.00%)  0 17/98 (17.35%)  32 17/81 (20.99%)  28
Hypoglycemia  1  0/15 (0.00%)  0 4/98 (4.08%)  7 3/81 (3.70%)  3
Hypokalemia  1  1/15 (6.67%)  1 21/98 (21.43%)  32 18/81 (22.22%)  36
Hypomagnesemia  1  0/15 (0.00%)  0 7/98 (7.14%)  13 6/81 (7.41%)  16
Hyponatremia  1  1/15 (6.67%)  1 14/98 (14.29%)  19 6/81 (7.41%)  8
Hypophosphatemia  1  2/15 (13.33%)  2 22/98 (22.45%)  36 20/81 (24.69%)  29
Metabolism and nutrition disorders - Other, elevated LDH  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Tumor lysis syndrome  1  0/15 (0.00%)  0 4/98 (4.08%)  4 0/81 (0.00%)  0
Metabolism and nutrition disorders - Other, malnutrition  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Back pain  1  1/15 (6.67%)  1 7/98 (7.14%)  10 7/81 (8.64%)  7
Bone pain  1  2/15 (13.33%)  3 9/98 (9.18%)  13 7/81 (8.64%)  10
Chest wall pain  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Flank pain  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Generalized muscle weakness  1  1/15 (6.67%)  1 4/98 (4.08%)  7 5/81 (6.17%)  6
Joint effusion  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Muscle weakness lower limb  1  0/15 (0.00%)  0 1/98 (1.02%)  2 0/81 (0.00%)  0
Muscle weakness trunk  1  0/15 (0.00%)  0 0/98 (0.00%)  0 2/81 (2.47%)  2
Musculoskeletal and connective tissue disorder - Other, specify  1 [1]  0/15 (0.00%)  0 1/98 (1.02%)  1 1/81 (1.23%)  1
Myalgia  1  1/15 (6.67%)  1 0/98 (0.00%)  0 1/81 (1.23%)  2
Neck pain  1  1/15 (6.67%)  1 3/98 (3.06%)  3 1/81 (1.23%)  1
Non-cardiac chest pain  1  0/15 (0.00%)  0 2/98 (2.04%)  2 0/81 (0.00%)  0
Pain in extremity  1  0/15 (0.00%)  0 2/98 (2.04%)  3 3/81 (3.70%)  4
Musculoskeletal and connective tissue disorder - Other, shin pain with numbness  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Nervous system disorders       
Cerebrospinal fluid leakage  1  0/15 (0.00%)  0 2/98 (2.04%)  3 0/81 (0.00%)  0
Cognitive disturbance  1  0/15 (0.00%)  0 1/98 (1.02%)  2 0/81 (0.00%)  0
Depressed level of consciousness  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Dizziness  1  0/15 (0.00%)  0 7/98 (7.14%)  9 3/81 (3.70%)  5
Dysgeusia  1  0/15 (0.00%)  0 1/98 (1.02%)  1 5/81 (6.17%)  6
Dysphasia  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Facial nerve disorder  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Headache  1  1/15 (6.67%)  2 25/98 (25.51%)  31 11/81 (13.58%)  13
Memory impairment  1  0/15 (0.00%)  0 2/98 (2.04%)  5 1/81 (1.23%)  1
Movements involuntary  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Nervous system disorders - Other, numbness in left arm  1  1/15 (6.67%)  3 0/98 (0.00%)  0 2/81 (2.47%)  6
Paresthesia  1  0/15 (0.00%)  0 5/98 (5.10%)  5 3/81 (3.70%)  10
Peripheral motor neuropathy  1  0/15 (0.00%)  0 8/98 (8.16%)  9 8/81 (9.88%)  9
Peripheral sensory neuropathy  1  5/15 (33.33%)  5 26/98 (26.53%)  33 22/81 (27.16%)  25
Presyncope  1  0/15 (0.00%)  0 2/98 (2.04%)  4 2/81 (2.47%)  2
Seizure  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Somnolence  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Syncope  1  0/15 (0.00%)  0 5/98 (5.10%)  7 2/81 (2.47%)  2
Tremor  1  0/15 (0.00%)  0 2/98 (2.04%)  2 0/81 (0.00%)  0
Nervous system disorders - Other, neuropathy  1  1/15 (6.67%)  1 0/98 (0.00%)  0 1/81 (1.23%)  5
Nervous system disorders - Other, neuropathy, upper bilateral extremities  1  2/15 (13.33%)  2 0/98 (0.00%)  0 0/81 (0.00%)  0
Psychiatric disorders       
Agitation  1  0/15 (0.00%)  0 2/98 (2.04%)  2 1/81 (1.23%)  1
Anxiety  1  0/15 (0.00%)  0 1/98 (1.02%)  1 2/81 (2.47%)  2
Confusion  1  0/15 (0.00%)  0 3/98 (3.06%)  3 2/81 (2.47%)  2
Delirium  1  0/15 (0.00%)  0 1/98 (1.02%)  1 1/81 (1.23%)  1
Delusions  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Depression  1  0/15 (0.00%)  0 3/98 (3.06%)  3 1/81 (1.23%)  1
Insomnia  1  1/15 (6.67%)  1 10/98 (10.20%)  12 6/81 (7.41%)  6
Personality change  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Psychiatric disorders - Other, non verbal  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury  1  0/15 (0.00%)  0 0/98 (0.00%)  0 2/81 (2.47%)  2
Hematuria  1  0/15 (0.00%)  0 2/98 (2.04%)  2 0/81 (0.00%)  0
Renal and urinary disorders - Other, dysuria  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Urinary frequency  1  0/15 (0.00%)  0 0/98 (0.00%)  0 2/81 (2.47%)  2
Urinary tract pain  1  1/15 (6.67%)  1 1/98 (1.02%)  1 2/81 (2.47%)  2
Urinary urgency  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Reproductive system and breast disorders       
Scrotal pain  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis  1  0/15 (0.00%)  0 1/98 (1.02%)  1 2/81 (2.47%)  2
Aspiration  1  0/15 (0.00%)  0 0/98 (0.00%)  0 3/81 (3.70%)  3
Cough  1  0/15 (0.00%)  0 6/98 (6.12%)  6 1/81 (1.23%)  1
Dyspnea  1  1/15 (6.67%)  1 8/98 (8.16%)  9 7/81 (8.64%)  9
Epistaxis  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Hiccups  1  0/15 (0.00%)  0 3/98 (3.06%)  3 0/81 (0.00%)  0
Hoarseness  1  0/15 (0.00%)  0 2/98 (2.04%)  2 1/81 (1.23%)  1
Hypoxia  1  0/15 (0.00%)  0 0/98 (0.00%)  0 2/81 (2.47%)  2
Laryngeal inflammation  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Laryngeal mucositis  1  0/15 (0.00%)  0 2/98 (2.04%)  2 0/81 (0.00%)  0
Nasal congestion  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Pharyngeal mucositis  1  0/15 (0.00%)  0 1/98 (1.02%)  1 1/81 (1.23%)  1
Pharyngolaryngeal pain  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Pleural effusion  1  0/15 (0.00%)  0 1/98 (1.02%)  1 2/81 (2.47%)  2
Pneumonitis  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Postnasal drip  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Productive cough  1  0/15 (0.00%)  0 0/98 (0.00%)  0 2/81 (2.47%)  2
Pulmonary edema  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Respiratory failure  1  0/15 (0.00%)  0 0/98 (0.00%)  0 2/81 (2.47%)  2
Sleep apnea  1  1/15 (6.67%)  3 1/98 (1.02%)  1 0/81 (0.00%)  0
Sore throat  1  0/15 (0.00%)  0 4/98 (4.08%)  5 1/81 (1.23%)  1
Tracheal fistula  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Skin and subcutaneous tissue disorders       
Alopecia  1  4/15 (26.67%)  6 9/98 (9.18%)  14 6/81 (7.41%)  6
Dry skin  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Hyperhidrosis  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Nail discoloration  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Nail loss  1  0/15 (0.00%)  0 2/98 (2.04%)  2 0/81 (0.00%)  0
Pain of skin  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Papulopustular rash  1  0/15 (0.00%)  0 2/98 (2.04%)  2 0/81 (0.00%)  0
Pruritus  1  0/15 (0.00%)  0 3/98 (3.06%)  3 1/81 (1.23%)  1
Rash acneiform  1  0/15 (0.00%)  0 0/98 (0.00%)  0 3/81 (3.70%)  3
Rash maculo-papular  1  0/15 (0.00%)  0 1/98 (1.02%)  1 1/81 (1.23%)  1
Rash pustular  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Skin and subcutaneous tissue disorders - Other, abdominal abscess  1  2/15 (13.33%)  2 4/98 (4.08%)  5 1/81 (1.23%)  1
Skin hyperpigmentation  1  0/15 (0.00%)  0 2/98 (2.04%)  2 0/81 (0.00%)  0
Skin ulceration  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Urticaria  1  0/15 (0.00%)  0 0/98 (0.00%)  0 2/81 (2.47%)  2
Skin and subcutaneous tissue disorders - Other, blister ball of R foot  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, dermatitis  1  0/15 (0.00%)  0 0/98 (0.00%)  0 1/81 (1.23%)  1
Skin and subcutaneous tissue disorders - Other, forehead itching  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, skin darkening  1  1/15 (6.67%)  1 0/98 (0.00%)  0 0/81 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, vitiligo  1  1/15 (6.67%)  1 0/98 (0.00%)  0 0/81 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, pressure ulcer  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, scalp wound  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Vascular disorders       
Hematoma  1  0/15 (0.00%)  0 3/98 (3.06%)  4 0/81 (0.00%)  0
Hot flashes  1  0/15 (0.00%)  0 1/98 (1.02%)  1 0/81 (0.00%)  0
Hypertension  1  1/15 (6.67%)  1 5/98 (5.10%)  9 6/81 (7.41%)  12
Hypotension  1  0/15 (0.00%)  0 8/98 (8.16%)  9 6/81 (7.41%)  8
Superficial thrombophlebitis  1  0/15 (0.00%)  0 2/98 (2.04%)  2 0/81 (0.00%)  0
Thromboembolic event  1  0/15 (0.00%)  0 6/98 (6.12%)  6 5/81 (6.17%)  5
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
PICC line-associated shoulder pain
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dr. Mark J. Roschewski
Organization: National Cancer Institute
Phone: 240-760-6183
EMail: roschewskimj@nih.gov
Layout table for additonal information
Responsible Party: Mark Roschewski, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01092182    
Other Study ID Numbers: 100052
10-C-0052
First Submitted: March 23, 2010
First Posted: March 24, 2010
Results First Submitted: September 29, 2021
Results First Posted: October 19, 2021
Last Update Posted: November 9, 2022