NCT00392990 · ADVERSE EVENTS

Adverse events

Doxorubicin Hydrochloride Liposome and Rituximab With Combination Chemotherapy in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Burkitt-Like Lymphoma · Source last updated 2019-10-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. Treatment duration was at a median of 13 weeks (range 11-20) for high-risk patients and 10 weeks (range 9-12) for low-risk patients.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles Patients are stratified between high risk and low risk disease status. High risk patients receive 1 cycle of R-CODOX-M chemotherapy IV followed by R-IVAC chemotherapy over 30 minutes(Regimen B); regimens A and B are then repeated. Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)	20 / 20	20 / 20	4 / 20
Low Risk - Treatment With 3 Cycles of R-CODOX-M Patients are stratified between high risk and low risk disease status. Low risk patients receive 3 cycles of rituximab (500 mg/m2) R-CODOX-M chemotherapy IV over 2-4 hours with intrathecal chemotherapy (Regimen A). Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)	2 / 5	5 / 5	0 / 5

Group identifiers: EG000: High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles · EG001: Low Risk - Treatment With 3 Cycles of R-CODOX-M

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Systematic Assessment
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
myelodysplastic syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Cardiac dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Pleuritic chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
GI bleed
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Cerebritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
20
num Events
7
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
Febrile neutropnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
num Events
2
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Bloodinfection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
20
num Events
3
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Neuro symptoms - Seizure

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
5
term
Allergic reaction/ hypersensitivity (including drug fever)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
18
num At Risk
20
group Id
EG001
num Affected
5
num At Risk
5
term
Hemoglobin (anemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
11
num At Risk
20
group Id
EG001
num Affected
3
num At Risk
5
term
Neutrophils (neutropenia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
20
num At Risk
20
group Id
EG001
num Affected
5
num At Risk
5
term
Leukocytes (total WBC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
10
num At Risk
20
group Id
EG001
num Affected
3
num At Risk
5
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
20
num At Risk
20
group Id
EG001
num Affected
4
num At Risk
5
term
Platelets (thrombocytopenia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
5
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
5
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
5
term
Cardiac General
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
5
term
Left ventricular diastolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
5
term
LVEF
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
5
term
Palpitations

Complete source fields

event Groups

deaths Num Affected
4
deaths Num At Risk
20
description
Patients are stratified between high risk and low risk disease status. High risk patients receive 1 cycle of R-CODOX-M chemotherapy IV followed by R-IVAC chemotherapy over 30 minutes(Regimen B); regimens A and B are then repeated. Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)
id
EG000
other Num Affected
20
other Num At Risk
20
serious Num Affected
20
serious Num At Risk
20
title
High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles
deaths Num Affected
0
deaths Num At Risk
5
description
Patients are stratified between high risk and low risk disease status. Low risk patients receive 3 cycles of rituximab (500 mg/m2) R-CODOX-M chemotherapy IV over 2-4 hours with intrathecal chemotherapy (Regimen A). Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)
id
EG001
other Num Affected
5
other Num At Risk
5
serious Num Affected
2
serious Num At Risk
5
title
Low Risk - Treatment With 3 Cycles of R-CODOX-M

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
5
term
Allergic reaction/ hypersensitivity (including drug fever)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
18
num At Risk
20
group Id
EG001
num Affected
5
num At Risk
5
term
Hemoglobin (anemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
11
num At Risk
20
group Id
EG001
num Affected
3
num At Risk
5
term
Neutrophils (neutropenia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
20
num At Risk
20
group Id
EG001
num Affected
5
num At Risk
5
term
Leukocytes (total WBC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
10
num At Risk
20
group Id
EG001
num Affected
3
num At Risk
5
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
20
num At Risk
20
group Id
EG001
num Affected
4
num At Risk
5
term
Platelets (thrombocytopenia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
5
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
5
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
5
term
Cardiac General
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
5
term
Left ventricular diastolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
5
term
LVEF
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
5
term
Palpitations

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Systematic Assessment
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
myelodysplastic syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Cardiac dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Pleuritic chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
GI bleed
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Cerebritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
20
num Events
7
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
Febrile neutropnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
num Events
2
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Bloodinfection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
20
num Events
3
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Neuro symptoms - Seizure

time Frame

Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. Treatment duration was at a median of 13 weeks (range 11-20) for high-risk patients and 10 weeks (range 9-12) for low-risk patients.

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Preserved source evidence · Not medical advice