Trial Outcomes & Findings for Rituximab, Chemotherapy, and Filgrastim in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia (NCT NCT00039130)
NCT ID: NCT00039130
Last Updated: 2023-08-21
Results Overview
Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
105 participants
Primary outcome timeframe
6 months
Results posted on
2023-08-21
Participant Flow
Participant milestones
| Measure |
Rituximab With High Intensity Chemotherapy
Cycle1: Cyclophosphamide 100 mg/m\^2/day (d) IV (d 1-5), Prednisone 60 mg/m\^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)
Cycle 2, 4 \& 6 (21 day): Ifosfamide 800 mg/m\^2/d (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 25 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m\^2/d over 2 h (d 4-5), Etoposide 80 mg/m\^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m\^2 d 8 cycle 2 only, 375 mg/m\^2/d (d 10, 12 cycle 2, d 8 cycle 4 \& 6)
Cycle 3, 5 \& 7 (21 day): Cyclophosphamide 200 mg/m\^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 50 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m\^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m\^2/d (d 8)
|
|---|---|
|
Overall Study
STARTED
|
105
|
|
Overall Study
COMPLETED
|
75
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Rituximab With High Intensity Chemotherapy
Cycle1: Cyclophosphamide 100 mg/m\^2/day (d) IV (d 1-5), Prednisone 60 mg/m\^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)
Cycle 2, 4 \& 6 (21 day): Ifosfamide 800 mg/m\^2/d (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 25 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m\^2/d over 2 h (d 4-5), Etoposide 80 mg/m\^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m\^2 d 8 cycle 2 only, 375 mg/m\^2/d (d 10, 12 cycle 2, d 8 cycle 4 \& 6)
Cycle 3, 5 \& 7 (21 day): Cyclophosphamide 200 mg/m\^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 50 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m\^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m\^2/d (d 8)
|
|---|---|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Death
|
9
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Progression
|
2
|
|
Overall Study
Subsequent treatment
|
2
|
|
Overall Study
Physician Decision
|
3
|
Baseline Characteristics
Rituximab, Chemotherapy, and Filgrastim in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia
Baseline characteristics by cohort
| Measure |
Rituximab With High Intensity Chemotherapy
n=105 Participants
Cycle1: Cyclophosphamide 100 mg/m\^2/day (d) IV (d 1-5), Prednisone 60 mg/m\^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)
Cycle 2, 4 \& 6 (21 day): Ifosfamide 800 mg/m\^2/d (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 25 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m\^2/d over 2 h (d 4-5), Etoposide 80 mg/m\^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m\^2 d 8 cycle 2 only, 375 mg/m\^2/d (d 10, 12 cycle 2, d 8 cycle 4 \& 6)
Cycle 3, 5 \& 7 (21 day): Cyclophosphamide 200 mg/m\^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 50 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m\^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m\^2/d (d 8)
|
|---|---|
|
Age, Continuous
|
43 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
98 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
105 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsResponse is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease.
Outcome measures
| Measure |
Rituximab With High Intensity Chemotherapy
n=105 Participants
Cycle1: Cyclophosphamide 100 mg/m\^2/day (d) IV (d 1-5), Prednisone 60 mg/m\^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)
Cycle 2, 4 \& 6 (21 day): Ifosfamide 800 mg/m\^2/d (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 25 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m\^2/d over 2 h (d 4-5), Etoposide 80 mg/m\^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m\^2 d 8 cycle 2 only, 375 mg/m\^2/d (d 10, 12 cycle 2, d 8 cycle 4 \& 6)
Cycle 3, 5 \& 7 (21 day): Cyclophosphamide 200 mg/m\^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 50 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m\^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m\^2/d (d 8)
|
|---|---|
|
Complete Response Rate
|
83 percentage of participants
Interval 74.0 to 90.0
|
SECONDARY outcome
Timeframe: 2 yearsPercentage of patients who were event free at 2 years. The 2-year event free rate was estimated using the Kaplan Meier method. An event is defined as death, progression or treatment failure.
Outcome measures
| Measure |
Rituximab With High Intensity Chemotherapy
n=105 Participants
Cycle1: Cyclophosphamide 100 mg/m\^2/day (d) IV (d 1-5), Prednisone 60 mg/m\^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)
Cycle 2, 4 \& 6 (21 day): Ifosfamide 800 mg/m\^2/d (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 25 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m\^2/d over 2 h (d 4-5), Etoposide 80 mg/m\^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m\^2 d 8 cycle 2 only, 375 mg/m\^2/d (d 10, 12 cycle 2, d 8 cycle 4 \& 6)
Cycle 3, 5 \& 7 (21 day): Cyclophosphamide 200 mg/m\^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 50 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m\^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m\^2/d (d 8)
|
|---|---|
|
2 Year Event Free Survival
|
78 percentage of participants
Interval 69.0 to 85.0
|
SECONDARY outcome
Timeframe: 2 yearsPercentage of participants who were alive at 2 years. The 2 year survival, with 95% confidence interval, was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Rituximab With High Intensity Chemotherapy
n=105 Participants
Cycle1: Cyclophosphamide 100 mg/m\^2/day (d) IV (d 1-5), Prednisone 60 mg/m\^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)
Cycle 2, 4 \& 6 (21 day): Ifosfamide 800 mg/m\^2/d (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 25 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m\^2/d over 2 h (d 4-5), Etoposide 80 mg/m\^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m\^2 d 8 cycle 2 only, 375 mg/m\^2/d (d 10, 12 cycle 2, d 8 cycle 4 \& 6)
Cycle 3, 5 \& 7 (21 day): Cyclophosphamide 200 mg/m\^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 50 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m\^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m\^2/d (d 8)
|
|---|---|
|
2 Year Overall Survival
|
80 percentage of participants
Interval 71.0 to 86.0
|
Adverse Events
Rituximab With High Intensity Chemotherapy
Serious events: 61 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab With High Intensity Chemotherapy
n=105 participants at risk
Cycle1: Cyclophosphamide 100 mg/m\^2/day (d) IV (d 1-5), Prednisone 60 mg/m\^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)
Cycle 2, 4 \& 6 (21 day): Ifosfamide 800 mg/m\^2/d (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 25 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m\^2/d over 2 h (d 4-5), Etoposide 80 mg/m\^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m\^2 d 8 cycle 2 only, 375 mg/m\^2/d (d 10, 12 cycle 2, d 8 cycle 4 \& 6)
Cycle 3, 5 \& 7 (21 day): Cyclophosphamide 200 mg/m\^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 50 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m\^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m\^2/d (d 8)
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
29.5%
31/105 • Number of events 40
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
55.2%
58/105 • Number of events 81
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
1.9%
2/105 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymphatics
|
0.95%
1/105 • Number of events 1
|
|
Blood and lymphatic system disorders
Transfusion: Platelets
|
2.9%
3/105 • Number of events 3
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs
|
4.8%
5/105 • Number of events 6
|
|
Cardiac disorders
Arrhythmia
|
3.8%
4/105 • Number of events 4
|
|
Cardiac disorders
Arrhythmia supraventricular
|
3.8%
4/105 • Number of events 4
|
|
Cardiac disorders
Cardiac disorder
|
2.9%
3/105 • Number of events 3
|
|
Cardiac disorders
Conduction disorder
|
1.9%
2/105 • Number of events 2
|
|
Cardiac disorders
Edema
|
19.0%
20/105 • Number of events 21
|
|
Cardiac disorders
Left ventricular failure
|
3.8%
4/105 • Number of events 4
|
|
Cardiac disorders
Myocardial ischemia
|
0.95%
1/105 • Number of events 1
|
|
Cardiac disorders
Myocarditis
|
0.95%
1/105 • Number of events 1
|
|
Cardiac disorders
Nodal arrhythmia
|
0.95%
1/105 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
2.9%
3/105 • Number of events 3
|
|
Cardiac disorders
Sinus bradycardia
|
1.9%
2/105 • Number of events 2
|
|
Cardiac disorders
Sinus tachycardia
|
10.5%
11/105 • Number of events 13
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.9%
2/105 • Number of events 2
|
|
Ear and labyrinth disorders
Ear disorder
|
1.9%
2/105 • Number of events 2
|
|
Ear and labyrinth disorders
Ear pain
|
0.95%
1/105 • Number of events 1
|
|
Endocrine disorders
Cushingoid
|
0.95%
1/105 • Number of events 1
|
|
Eye disorders
Eye disorder
|
0.95%
1/105 • Number of events 1
|
|
Eye disorders
Photophobia
|
0.95%
1/105 • Number of events 1
|
|
Eye disorders
Vision blurred
|
3.8%
4/105 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal distension
|
0.95%
1/105 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
11.4%
12/105 • Number of events 13
|
|
Gastrointestinal disorders
Anal fistula
|
0.95%
1/105 • Number of events 1
|
|
Gastrointestinal disorders
Anal pain
|
0.95%
1/105 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
3.8%
4/105 • Number of events 5
|
|
Gastrointestinal disorders
Colitis
|
1.9%
2/105 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
13.3%
14/105 • Number of events 15
|
|
Gastrointestinal disorders
Diarrhea
|
25.7%
27/105 • Number of events 30
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
2/105 • Number of events 2
|
|
Gastrointestinal disorders
Esophagitis
|
26.7%
28/105 • Number of events 34
|
|
Gastrointestinal disorders
Flatulence
|
1.9%
2/105 • Number of events 2
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.9%
2/105 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
0.95%
1/105 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.9%
2/105 • Number of events 2
|
|
Gastrointestinal disorders
Gingival pain
|
0.95%
1/105 • Number of events 1
|
|
Gastrointestinal disorders
Hematemesis
|
0.95%
1/105 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.9%
2/105 • Number of events 2
|
|
Gastrointestinal disorders
Ileus
|
2.9%
3/105 • Number of events 3
|
|
Gastrointestinal disorders
Melena/GI bleeding
|
1.9%
2/105 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis oral
|
42.9%
45/105 • Number of events 59
|
|
Gastrointestinal disorders
Nausea
|
30.5%
32/105 • Number of events 41
|
|
Gastrointestinal disorders
Oral pain
|
3.8%
4/105 • Number of events 4
|
|
Gastrointestinal disorders
Proctitis
|
0.95%
1/105 • Number of events 1
|
|
Gastrointestinal disorders
Rectal bleeding/hematochezia
|
4.8%
5/105 • Number of events 6
|
|
Gastrointestinal disorders
Rectal pain
|
1.9%
2/105 • Number of events 4
|
|
Gastrointestinal disorders
Typhlitis
|
0.95%
1/105 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
21.0%
22/105 • Number of events 25
|
|
General disorders
Chest pain
|
2.9%
3/105 • Number of events 3
|
|
General disorders
Chills
|
9.5%
10/105 • Number of events 12
|
|
General disorders
Edema limbs
|
3.8%
4/105 • Number of events 4
|
|
General disorders
Fatigue
|
29.5%
31/105 • Number of events 37
|
|
General disorders
Fever
|
10.5%
11/105 • Number of events 11
|
|
General disorders
General symptom
|
0.95%
1/105 • Number of events 1
|
|
General disorders
Pain
|
22.9%
24/105 • Number of events 27
|
|
Hepatobiliary disorders
Cholecystitis
|
1.9%
2/105 • Number of events 2
|
|
Hepatobiliary disorders
Hepatic failure
|
0.95%
1/105 • Number of events 1
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.95%
1/105 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Anal infection
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
3.8%
4/105 • Number of events 4
|
|
Infections and infestations
Infection
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Infection with grade 3 or 4 neutropenia
|
30.5%
32/105 • Number of events 36
|
|
Infections and infestations
Infection with unknown ANC
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Infection without neutropenia
|
18.1%
19/105 • Number of events 20
|
|
Infections and infestations
Infectious colitis
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Skin infection
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Wound-infectious
|
1.9%
2/105 • Number of events 2
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.95%
1/105 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.95%
1/105 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
6.7%
7/105 • Number of events 8
|
|
Investigations
Alanine aminotransferase increased
|
26.7%
28/105 • Number of events 36
|
|
Investigations
Alkaline phosphatase
|
16.2%
17/105 • Number of events 21
|
|
Investigations
Alkaline phosphatase increased
|
2.9%
3/105 • Number of events 3
|
|
Investigations
Amylase increased
|
0.95%
1/105 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
23.8%
25/105 • Number of events 32
|
|
Investigations
Blood bilirubin increased
|
21.0%
22/105 • Number of events 23
|
|
Investigations
Cardiac troponin I increased
|
1.9%
2/105 • Number of events 2
|
|
Investigations
Coagulopathy
|
1.9%
2/105 • Number of events 2
|
|
Investigations
Creatinine increased
|
24.8%
26/105 • Number of events 29
|
|
Investigations
INR increased
|
1.9%
2/105 • Number of events 2
|
|
Investigations
Laboratory test abnormal
|
6.7%
7/105 • Number of events 8
|
|
Investigations
Leukocyte count decreased
|
18.1%
19/105 • Number of events 26
|
|
Investigations
Lipase increased
|
0.95%
1/105 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
12.4%
13/105 • Number of events 16
|
|
Investigations
Neutrophil count decreased
|
52.4%
55/105 • Number of events 72
|
|
Investigations
Platelet count decreased
|
53.3%
56/105 • Number of events 75
|
|
Investigations
Weight gain
|
1.9%
2/105 • Number of events 2
|
|
Investigations
Weight loss
|
6.7%
7/105 • Number of events 7
|
|
Metabolism and nutrition disorders
Acidosis
|
3.8%
4/105 • Number of events 4
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.95%
1/105 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
15.2%
16/105 • Number of events 18
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
44.8%
47/105 • Number of events 63
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
3.8%
4/105 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
4/105 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
21.9%
23/105 • Number of events 31
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
30.5%
32/105 • Number of events 40
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
1.9%
2/105 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
4.8%
5/105 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
19.0%
20/105 • Number of events 25
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
4.8%
5/105 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
11.4%
12/105 • Number of events 12
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
38.1%
40/105 • Number of events 49
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
2.9%
3/105 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
14.3%
15/105 • Number of events 20
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
6.7%
7/105 • Number of events 7
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
2.9%
3/105 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
3/105 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
4/105 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.8%
5/105 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.95%
1/105 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.95%
1/105 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
4/105 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.95%
1/105 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.95%
1/105 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
0.95%
1/105 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
3.8%
4/105 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
6.7%
7/105 • Number of events 7
|
|
Nervous system disorders
Encephalopathy
|
0.95%
1/105 • Number of events 1
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.95%
1/105 • Number of events 1
|
|
Nervous system disorders
Headache
|
18.1%
19/105 • Number of events 22
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.95%
1/105 • Number of events 1
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.95%
1/105 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.95%
1/105 • Number of events 1
|
|
Nervous system disorders
Neurological disorder NOS
|
0.95%
1/105 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.7%
6/105 • Number of events 7
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.4%
13/105 • Number of events 13
|
|
Nervous system disorders
Seizure
|
2.9%
3/105 • Number of events 3
|
|
Nervous system disorders
Speech disorder
|
1.9%
2/105 • Number of events 2
|
|
Nervous system disorders
Syncope
|
0.95%
1/105 • Number of events 1
|
|
Nervous system disorders
Tremor
|
2.9%
3/105 • Number of events 3
|
|
Psychiatric disorders
Agitation
|
0.95%
1/105 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
6.7%
7/105 • Number of events 8
|
|
Psychiatric disorders
Confusion
|
7.6%
8/105 • Number of events 8
|
|
Psychiatric disorders
Depression
|
8.6%
9/105 • Number of events 9
|
|
Psychiatric disorders
Insomnia
|
2.9%
3/105 • Number of events 3
|
|
Psychiatric disorders
Personality change
|
0.95%
1/105 • Number of events 1
|
|
Psychiatric disorders
Psychosis
|
0.95%
1/105 • Number of events 1
|
|
Renal and urinary disorders
Bladder pain
|
0.95%
1/105 • Number of events 1
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
1.9%
2/105 • Number of events 2
|
|
Renal and urinary disorders
Hematuria (in the absence of vaginal bleeding)
|
2.9%
3/105 • Number of events 4
|
|
Renal and urinary disorders
Proteinuria
|
0.95%
1/105 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
6.7%
7/105 • Number of events 7
|
|
Renal and urinary disorders
Urethral fistula
|
0.95%
1/105 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
0.95%
1/105 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
0.95%
1/105 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.95%
1/105 • Number of events 1
|
|
Renal and urinary disorders
Urogenital disorder
|
4.8%
5/105 • Number of events 5
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.95%
1/105 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
4.8%
5/105 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.8%
4/105 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.9%
2/105 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.95%
1/105 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
10/105 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.95%
1/105 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
13.3%
14/105 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.8%
4/105 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.95%
1/105 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.9%
3/105 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.6%
9/105 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.9%
2/105 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.6%
8/105 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.95%
1/105 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
3/105 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.9%
2/105 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
6.7%
7/105 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.95%
1/105 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.8%
4/105 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.95%
1/105 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.9%
2/105 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.9%
3/105 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
0.95%
1/105 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.95%
1/105 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.95%
1/105 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.95%
1/105 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
3/105 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
13.3%
14/105 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
2.9%
3/105 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.95%
1/105 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
7.6%
8/105 • Number of events 8
|
|
Vascular disorders
Flushing
|
0.95%
1/105 • Number of events 1
|
|
Vascular disorders
Hemorrhage
|
1.9%
2/105 • Number of events 2
|
|
Vascular disorders
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
|
2.9%
3/105 • Number of events 3
|
|
Vascular disorders
Hypertension
|
9.5%
10/105 • Number of events 10
|
|
Vascular disorders
Hypotension
|
13.3%
14/105 • Number of events 17
|
|
Vascular disorders
Phlebitis
|
0.95%
1/105 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
3.8%
4/105 • Number of events 4
|
Other adverse events
| Measure |
Rituximab With High Intensity Chemotherapy
n=105 participants at risk
Cycle1: Cyclophosphamide 100 mg/m\^2/day (d) IV (d 1-5), Prednisone 60 mg/m\^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)
Cycle 2, 4 \& 6 (21 day): Ifosfamide 800 mg/m\^2/d (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 25 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m\^2/d over 2 h (d 4-5), Etoposide 80 mg/m\^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m\^2 d 8 cycle 2 only, 375 mg/m\^2/d (d 10, 12 cycle 2, d 8 cycle 4 \& 6)
Cycle 3, 5 \& 7 (21 day): Cyclophosphamide 200 mg/m\^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 50 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m\^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m\^2/d (d 8)
|
|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
1.9%
2/105 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
61.9%
65/105 • Number of events 130
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
95.2%
100/105 • Number of events 642
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.95%
1/105 • Number of events 1
|
|
Blood and lymphatic system disorders
Transfusion: Platelets
|
17.1%
18/105 • Number of events 41
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs
|
17.1%
18/105 • Number of events 72
|
|
Cardiac disorders
Arrhythmia
|
3.8%
4/105 • Number of events 4
|
|
Cardiac disorders
Arrhythmia supraventricular
|
3.8%
4/105 • Number of events 5
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
2/105 • Number of events 2
|
|
Cardiac disorders
Cardiac disorder
|
9.5%
10/105 • Number of events 10
|
|
Cardiac disorders
Edema
|
36.2%
38/105 • Number of events 80
|
|
Cardiac disorders
Left ventricular failure
|
2.9%
3/105 • Number of events 5
|
|
Cardiac disorders
Myocardial ischemia
|
0.95%
1/105 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
1.9%
2/105 • Number of events 2
|
|
Cardiac disorders
Sinus bradycardia
|
10.5%
11/105 • Number of events 12
|
|
Cardiac disorders
Sinus tachycardia
|
21.0%
22/105 • Number of events 35
|
|
Ear and labyrinth disorders
Ear disorder
|
3.8%
4/105 • Number of events 4
|
|
Ear and labyrinth disorders
Ear pain
|
2.9%
3/105 • Number of events 3
|
|
Ear and labyrinth disorders
Tinnitus
|
0.95%
1/105 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.95%
1/105 • Number of events 1
|
|
Endocrine disorders
Endocrine disorder
|
1.9%
2/105 • Number of events 2
|
|
Eye disorders
Conjunctivitis
|
3.8%
4/105 • Number of events 4
|
|
Eye disorders
Diplopia
|
1.9%
2/105 • Number of events 3
|
|
Eye disorders
Dry eye syndrome
|
4.8%
5/105 • Number of events 6
|
|
Eye disorders
Eye disorder
|
8.6%
9/105 • Number of events 12
|
|
Eye disorders
Flashing vision
|
2.9%
3/105 • Number of events 3
|
|
Eye disorders
Photophobia
|
1.9%
2/105 • Number of events 2
|
|
Eye disorders
Vision blurred
|
9.5%
10/105 • Number of events 15
|
|
Eye disorders
Watering eyes
|
4.8%
5/105 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal distension
|
4.8%
5/105 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain
|
41.0%
43/105 • Number of events 78
|
|
Gastrointestinal disorders
Anal fistula
|
2.9%
3/105 • Number of events 4
|
|
Gastrointestinal disorders
Anal pain
|
1.9%
2/105 • Number of events 2
|
|
Gastrointestinal disorders
Ascites
|
0.95%
1/105 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
50.5%
53/105 • Number of events 111
|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
63/105 • Number of events 127
|
|
Gastrointestinal disorders
Dry mouth
|
11.4%
12/105 • Number of events 14
|
|
Gastrointestinal disorders
Dyspepsia
|
22.9%
24/105 • Number of events 39
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
5.7%
6/105 • Number of events 6
|
|
Gastrointestinal disorders
Esophageal pain
|
1.9%
2/105 • Number of events 3
|
|
Gastrointestinal disorders
Esophagitis
|
56.2%
59/105 • Number of events 121
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.95%
1/105 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
1.9%
2/105 • Number of events 3
|
|
Gastrointestinal disorders
Gastritis
|
0.95%
1/105 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
11.4%
12/105 • Number of events 14
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.9%
2/105 • Number of events 4
|
|
Gastrointestinal disorders
Ileus
|
1.9%
2/105 • Number of events 2
|
|
Gastrointestinal disorders
Melena/GI bleeding
|
4.8%
5/105 • Number of events 6
|
|
Gastrointestinal disorders
Mucositis oral
|
86.7%
91/105 • Number of events 325
|
|
Gastrointestinal disorders
Nausea
|
84.8%
89/105 • Number of events 294
|
|
Gastrointestinal disorders
Oral pain
|
5.7%
6/105 • Number of events 8
|
|
Gastrointestinal disorders
Proctitis
|
1.9%
2/105 • Number of events 2
|
|
Gastrointestinal disorders
Rectal bleeding/hematochezia
|
4.8%
5/105 • Number of events 5
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.9%
2/105 • Number of events 2
|
|
Gastrointestinal disorders
Rectal pain
|
9.5%
10/105 • Number of events 16
|
|
Gastrointestinal disorders
Vomiting
|
50.5%
53/105 • Number of events 121
|
|
General disorders
Chest pain
|
6.7%
7/105 • Number of events 8
|
|
General disorders
Chills
|
20.0%
21/105 • Number of events 28
|
|
General disorders
Edema limbs
|
7.6%
8/105 • Number of events 12
|
|
General disorders
Fatigue
|
75.2%
79/105 • Number of events 279
|
|
General disorders
Fever
|
24.8%
26/105 • Number of events 39
|
|
General disorders
General symptom
|
7.6%
8/105 • Number of events 9
|
|
General disorders
Ill-defined disorder
|
1.9%
2/105 • Number of events 2
|
|
General disorders
Injection site reaction
|
0.95%
1/105 • Number of events 1
|
|
General disorders
Localized edema
|
1.9%
2/105 • Number of events 2
|
|
General disorders
Pain
|
46.7%
49/105 • Number of events 113
|
|
Hepatobiliary disorders
Cholecystitis
|
0.95%
1/105 • Number of events 1
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
3.8%
4/105 • Number of events 7
|
|
Immune system disorders
Hypersensitivity
|
5.7%
6/105 • Number of events 8
|
|
Immune system disorders
Immune system disorder
|
1.9%
2/105 • Number of events 4
|
|
Infections and infestations
Abdominal infection
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Anorectal infection
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
5.7%
6/105 • Number of events 9
|
|
Infections and infestations
Infection
|
7.6%
8/105 • Number of events 12
|
|
Infections and infestations
Infection with grade 3 or 4 neutropenia
|
61.9%
65/105 • Number of events 144
|
|
Infections and infestations
Infection with unknown ANC
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Infection without neutropenia
|
48.6%
51/105 • Number of events 101
|
|
Infections and infestations
Mucosal infection
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Opportunistic infection
|
0.95%
1/105 • Number of events 2
|
|
Infections and infestations
Sepsis
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Skin infection
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
1.9%
2/105 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
1.9%
2/105 • Number of events 2
|
|
Infections and infestations
Wound-infectious
|
2.9%
3/105 • Number of events 3
|
|
Injury, poisoning and procedural complications
Bruising
|
4.8%
5/105 • Number of events 5
|
|
Injury, poisoning and procedural complications
Operative injury to bladder and/or ureter
|
0.95%
1/105 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.95%
1/105 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
11.4%
12/105 • Number of events 17
|
|
Investigations
Alanine aminotransferase increased
|
67.6%
71/105 • Number of events 236
|
|
Investigations
Alkaline phosphatase
|
43.8%
46/105 • Number of events 92
|
|
Investigations
Alkaline phosphatase increased
|
15.2%
16/105 • Number of events 29
|
|
Investigations
Amylase increased
|
1.9%
2/105 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
62.9%
66/105 • Number of events 175
|
|
Investigations
Blood bilirubin increased
|
39.0%
41/105 • Number of events 89
|
|
Investigations
Coagulopathy
|
3.8%
4/105 • Number of events 4
|
|
Investigations
Creatine phosphokinase increased
|
0.95%
1/105 • Number of events 1
|
|
Investigations
Creatinine increased
|
43.8%
46/105 • Number of events 139
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
0.95%
1/105 • Number of events 1
|
|
Investigations
Fibrinogen decreased
|
3.8%
4/105 • Number of events 5
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.9%
3/105 • Number of events 6
|
|
Investigations
INR increased
|
10.5%
11/105 • Number of events 20
|
|
Investigations
Laboratory test abnormal
|
16.2%
17/105 • Number of events 34
|
|
Investigations
Leukocyte count decreased
|
42.9%
45/105 • Number of events 169
|
|
Investigations
Lymphocyte count decreased
|
34.3%
36/105 • Number of events 137
|
|
Investigations
Neutrophil count decreased
|
93.3%
98/105 • Number of events 493
|
|
Investigations
Platelet count decreased
|
93.3%
98/105 • Number of events 596
|
|
Investigations
Serum cholesterol increased
|
1.9%
2/105 • Number of events 4
|
|
Investigations
Weight gain
|
4.8%
5/105 • Number of events 5
|
|
Investigations
Weight loss
|
20.0%
21/105 • Number of events 22
|
|
Metabolism and nutrition disorders
Anorexia
|
45.7%
48/105 • Number of events 103
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
0.95%
1/105 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
87.6%
92/105 • Number of events 452
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
7.6%
8/105 • Number of events 10
|
|
Metabolism and nutrition disorders
Dehydration
|
7.6%
8/105 • Number of events 10
|
|
Metabolism and nutrition disorders
Iron overload
|
0.95%
1/105 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
53.3%
56/105 • Number of events 167
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
65.7%
69/105 • Number of events 236
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
5.7%
6/105 • Number of events 15
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
15.2%
16/105 • Number of events 31
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
41.0%
43/105 • Number of events 80
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
22.9%
24/105 • Number of events 29
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
38.1%
40/105 • Number of events 102
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
73.3%
77/105 • Number of events 270
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
15.2%
16/105 • Number of events 20
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
41.0%
43/105 • Number of events 132
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
12.4%
13/105 • Number of events 20
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
2.9%
3/105 • Number of events 5
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
6.7%
7/105 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
11/105 • Number of events 17
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.9%
2/105 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.4%
13/105 • Number of events 29
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.2%
17/105 • Number of events 28
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
1.9%
2/105 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.95%
1/105 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
4.8%
5/105 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.95%
1/105 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
4.8%
5/105 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.0%
22/105 • Number of events 44
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.9%
3/105 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.95%
1/105 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
7/105 • Number of events 10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.95%
1/105 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain (onset or exacerbation of tumor pain due to treatment)
|
0.95%
1/105 • Number of events 1
|
|
Nervous system disorders
Arachnoiditis
|
0.95%
1/105 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
4.8%
5/105 • Number of events 7
|
|
Nervous system disorders
Depressed level of consciousness
|
1.9%
2/105 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
22.9%
24/105 • Number of events 39
|
|
Nervous system disorders
Dysgeusia
|
7.6%
8/105 • Number of events 9
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.95%
1/105 • Number of events 1
|
|
Nervous system disorders
Headache
|
53.3%
56/105 • Number of events 113
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.9%
2/105 • Number of events 3
|
|
Nervous system disorders
Memory impairment
|
1.9%
2/105 • Number of events 3
|
|
Nervous system disorders
Neuralgia
|
5.7%
6/105 • Number of events 14
|
|
Nervous system disorders
Neurological disorder NOS
|
7.6%
8/105 • Number of events 9
|
|
Nervous system disorders
Neuropathy - cranial
|
0.95%
1/105 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
21.9%
23/105 • Number of events 57
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
47.6%
50/105 • Number of events 206
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.95%
1/105 • Number of events 1
|
|
Nervous system disorders
Sense of smell
|
0.95%
1/105 • Number of events 1
|
|
Nervous system disorders
Syncope
|
2.9%
3/105 • Number of events 3
|
|
Nervous system disorders
Tremor
|
5.7%
6/105 • Number of events 10
|
|
Psychiatric disorders
Anxiety
|
20.0%
21/105 • Number of events 43
|
|
Psychiatric disorders
Confusion
|
11.4%
12/105 • Number of events 13
|
|
Psychiatric disorders
Depression
|
27.6%
29/105 • Number of events 56
|
|
Psychiatric disorders
Insomnia
|
28.6%
30/105 • Number of events 50
|
|
Psychiatric disorders
Libido decreased
|
1.9%
2/105 • Number of events 2
|
|
Psychiatric disorders
Personality change
|
1.9%
2/105 • Number of events 3
|
|
Psychiatric disorders
Psychosis
|
0.95%
1/105 • Number of events 1
|
|
Renal and urinary disorders
Bladder hemorrhage
|
0.95%
1/105 • Number of events 1
|
|
Renal and urinary disorders
Bladder pain
|
0.95%
1/105 • Number of events 1
|
|
Renal and urinary disorders
Bladder spasm
|
3.8%
4/105 • Number of events 7
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
6.7%
7/105 • Number of events 8
|
|
Renal and urinary disorders
Hematuria (in the absence of vaginal bleeding)
|
5.7%
6/105 • Number of events 7
|
|
Renal and urinary disorders
Incontinence
|
3.8%
4/105 • Number of events 4
|
|
Renal and urinary disorders
Proteinuria
|
0.95%
1/105 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
5.7%
6/105 • Number of events 8
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.95%
1/105 • Number of events 1
|
|
Renal and urinary disorders
Urethral pain
|
0.95%
1/105 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
6.7%
7/105 • Number of events 12
|
|
Renal and urinary disorders
Urinary incontinence
|
0.95%
1/105 • Number of events 2
|
|
Renal and urinary disorders
Urinary retention
|
3.8%
4/105 • Number of events 4
|
|
Renal and urinary disorders
Urogenital disorder
|
8.6%
9/105 • Number of events 12
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.8%
4/105 • Number of events 4
|
|
Reproductive system and breast disorders
Gynecomastia
|
1.9%
2/105 • Number of events 4
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.95%
1/105 • Number of events 2
|
|
Reproductive system and breast disorders
Pelvic pain
|
4.8%
5/105 • Number of events 5
|
|
Reproductive system and breast disorders
Reproductive tract disorder
|
0.95%
1/105 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal dryness
|
1.9%
2/105 • Number of events 6
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
1.9%
2/105 • Number of events 6
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.95%
1/105 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
14.3%
15/105 • Number of events 33
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.9%
3/105 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
35/105 • Number of events 75
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
4/105 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
21.0%
22/105 • Number of events 26
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
24.8%
26/105 • Number of events 34
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.95%
1/105 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
8.6%
9/105 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.7%
6/105 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.95%
1/105 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Laryngoscopy abnormal
|
0.95%
1/105 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.7%
7/105 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.5%
10/105 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.9%
2/105 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
3/105 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
16.2%
17/105 • Number of events 23
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
0.95%
1/105 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
3.8%
4/105 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
27.6%
29/105 • Number of events 56
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
2.9%
3/105 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.6%
8/105 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.9%
2/105 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
0.95%
1/105 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.95%
1/105 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.9%
2/105 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
12.4%
13/105 • Number of events 21
|
|
Skin and subcutaneous tissue disorders
Pigmentation changes (e.g., vitiligo)
|
1.9%
2/105 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.2%
16/105 • Number of events 23
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.95%
1/105 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
46.7%
49/105 • Number of events 78
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
9.5%
10/105 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.95%
1/105 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.9%
2/105 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Sweating
|
30.5%
32/105 • Number of events 52
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.95%
1/105 • Number of events 1
|
|
Vascular disorders
Flushing
|
3.8%
4/105 • Number of events 6
|
|
Vascular disorders
Hemorrhage
|
7.6%
8/105 • Number of events 8
|
|
Vascular disorders
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
|
3.8%
4/105 • Number of events 4
|
|
Vascular disorders
Hot flashes
|
2.9%
3/105 • Number of events 4
|
|
Vascular disorders
Hypertension
|
25.7%
27/105 • Number of events 53
|
|
Vascular disorders
Hypotension
|
21.9%
23/105 • Number of events 35
|
|
Vascular disorders
Lymphedema
|
0.95%
1/105 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
0.95%
1/105 • Number of events 2
|
|
Vascular disorders
Thrombosis
|
5.7%
6/105 • Number of events 9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior Sponsor approval
- Publication restrictions are in place
Restriction type: OTHER