Trial Outcomes & Findings for CINJALL: Treatment for Children With Acute Lymphocytic Leukemia (NCT NCT00176462)
NCT ID: NCT00176462
Last Updated: 2014-06-09
Results Overview
This measure looks at the percentage of patients on Arm 2 who did not experience a relapse at 5 years, where relapse is defined as the presence of progressive disease after the achievement of a complete remission.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
5 years
Results posted on
2014-06-09
Participant Flow
59 patients with ALL were enrolled between March, 2001 and September, 2005 at the Cancer Institute of New Jersey (outpatient clinical research facility) and 1 patient was enrolled at Jersey Shore University Medical Center (a community hospital).
Participant milestones
| Measure |
Arm 1 Standard Risk
6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
|
Arm 2 High Risk
6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
|
|---|---|---|
|
Induction (4 Weeks)
STARTED
|
21
|
39
|
|
Induction (4 Weeks)
COMPLETED
|
20
|
34
|
|
Induction (4 Weeks)
NOT COMPLETED
|
1
|
5
|
|
Consolidation (12 Weeks)
STARTED
|
20
|
34
|
|
Consolidation (12 Weeks)
COMPLETED
|
20
|
29
|
|
Consolidation (12 Weeks)
NOT COMPLETED
|
0
|
5
|
|
Delayed Intensification (8 Weeks)
STARTED
|
20
|
29
|
|
Delayed Intensification (8 Weeks)
COMPLETED
|
20
|
29
|
|
Delayed Intensification (8 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Intensive Continuation (8X8-week Cycles)
STARTED
|
20
|
29
|
|
Intensive Continuation (8X8-week Cycles)
COMPLETED
|
19
|
26
|
|
Intensive Continuation (8X8-week Cycles)
NOT COMPLETED
|
1
|
3
|
|
Continuation -up to 30mos Post Remission
STARTED
|
19
|
26
|
|
Continuation -up to 30mos Post Remission
COMPLETED
|
19
|
26
|
|
Continuation -up to 30mos Post Remission
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm 1 Standard Risk
6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
|
Arm 2 High Risk
6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
|
|---|---|---|
|
Induction (4 Weeks)
Withdrawal by Subject
|
0
|
2
|
|
Induction (4 Weeks)
Death
|
1
|
2
|
|
Induction (4 Weeks)
Lack of Efficacy
|
0
|
1
|
|
Consolidation (12 Weeks)
Patient moved to another state
|
0
|
1
|
|
Consolidation (12 Weeks)
Adverse Event
|
0
|
1
|
|
Consolidation (12 Weeks)
Lack of Efficacy
|
0
|
2
|
|
Consolidation (12 Weeks)
Not documented
|
0
|
1
|
|
Intensive Continuation (8X8-week Cycles)
Death
|
1
|
0
|
|
Intensive Continuation (8X8-week Cycles)
Lack of Efficacy
|
0
|
3
|
Baseline Characteristics
CINJALL: Treatment for Children With Acute Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Arm 1 Standard Risk
n=21 Participants
6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
|
Arm 2 High Risk
n=39 Participants
6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
3.71 years
STANDARD_DEVIATION 1.77 • n=5 Participants
|
16 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
11.7 years
STANDARD_DEVIATION 9.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
39 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Number of high risk ALL patients treated.
This measure looks at the percentage of patients on Arm 2 who did not experience a relapse at 5 years, where relapse is defined as the presence of progressive disease after the achievement of a complete remission.
Outcome measures
| Measure |
Arm 2 High Risk
n=37 Participants
6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
|
Arm 2 High Risk
6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
|
|---|---|---|
|
Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years
|
64.9 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: We did not analyze this outcome measure. The laboratory analysis was not performed. The Principal Investigator left the institution.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1 Standard Risk
Serious events: 20 serious events
Other events: 21 other events
Deaths: 0 deaths
Arm 2 High Risk
Serious events: 36 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 Standard Risk
n=21 participants at risk
6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
|
Arm 2 High Risk
n=39 participants at risk
6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
|
|---|---|---|
|
Blood and lymphatic system disorders
Platelets
|
23.8%
5/21 • Number of events 5 • 7 years, 6 months
|
12.8%
5/39 • Number of events 7 • 7 years, 6 months
|
|
General disorders
Thrombosis/embolism
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
General disorders
Fever
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
2.6%
1/39 • Number of events 2 • 7 years, 6 months
|
|
Infections and infestations
Febrile neutropenia
|
76.2%
16/21 • Number of events 29 • 7 years, 6 months
|
43.6%
17/39 • Number of events 35 • 7 years, 6 months
|
|
Infections and infestations
Infection with unknown ANC
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
7.7%
3/39 • Number of events 3 • 7 years, 6 months
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
5.1%
2/39 • Number of events 2 • 7 years, 6 months
|
|
Infections and infestations
Infection without neutropenia
|
14.3%
3/21 • Number of events 3 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Nervous system disorders
Neurology
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
0.00%
0/39 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.5%
2/21 • Number of events 2 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
14.3%
3/21 • Number of events 4 • 7 years, 6 months
|
5.1%
2/39 • Number of events 2 • 7 years, 6 months
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/21 • 7 years, 6 months
|
5.1%
2/39 • Number of events 2 • 7 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Allergic reaction/hypersensitivity
|
0.00%
0/21 • 7 years, 6 months
|
5.1%
2/39 • Number of events 2 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not due to neuropathy)
|
0.00%
0/21 • 7 years, 6 months
|
12.8%
5/39 • Number of events 7 • 7 years, 6 months
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/21 • 7 years, 6 months
|
7.7%
3/39 • Number of events 3 • 7 years, 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/21 • 7 years, 6 months
|
5.1%
2/39 • Number of events 2 • 7 years, 6 months
|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Stomatitis / pharyngitis
|
0.00%
0/21 • 7 years, 6 months
|
5.1%
2/39 • Number of events 3 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
General disorders
Anorexia
|
0.00%
0/21 • 7 years, 6 months
|
7.7%
3/39 • Number of events 3 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Hypokalemia
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
7.7%
3/39 • Number of events 4 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Fibrinogen
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Pancreatitis
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Vascular disorders
DIC (disseminated intravascular coagulation)
|
0.00%
0/21 • 7 years, 6 months
|
5.1%
2/39 • Number of events 2 • 7 years, 6 months
|
|
Gastrointestinal disorders
Typhlitis (inflammation of cecum)
|
0.00%
0/21 • 7 years, 6 months
|
5.1%
2/39 • Number of events 2 • 7 years, 6 months
|
|
Psychiatric disorders
Psychosis
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
0.00%
0/39 • 7 years, 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC) - Neutropenia
|
0.00%
0/21 • 7 years, 6 months
|
7.7%
3/39 • Number of events 4 • 7 years, 6 months
|
|
General disorders
Fatigue
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Broncohspasm
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
0.00%
0/21 • 7 years, 6 months
|
5.1%
2/39 • Number of events 2 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Nervous system disorders
Neuropathic pain
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
General disorders
Syncope
|
0.00%
0/21 • 7 years, 6 months
|
5.1%
2/39 • Number of events 2 • 7 years, 6 months
|
|
Renal and urinary disorders
Melena/GI bleeding - Hemorrhage
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
0.00%
0/39 • 7 years, 6 months
|
|
Cardiac disorders
Cardiac troponin I
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Relapsed leukemia
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
Other adverse events
| Measure |
Arm 1 Standard Risk
n=21 participants at risk
6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
|
Arm 2 High Risk
n=39 participants at risk
6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
|
|---|---|---|
|
Blood and lymphatic system disorders
Platelets
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
7.7%
3/39 • Number of events 4 • 7 years, 6 months
|
|
General disorders
Fever
|
57.1%
12/21 • Number of events 22 • 7 years, 6 months
|
38.5%
15/39 • Number of events 21 • 7 years, 6 months
|
|
Infections and infestations
Infection with unknown ANC
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
10.3%
4/39 • Number of events 4 • 7 years, 6 months
|
|
Infections and infestations
Infection without neutropenia
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/21 • 7 years, 6 months
|
7.7%
3/39 • Number of events 3 • 7 years, 6 months
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
14.3%
3/21 • Number of events 4 • 7 years, 6 months
|
0.00%
0/39 • 7 years, 6 months
|
|
Gastrointestinal disorders
Dehydration
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
12.8%
5/39 • Number of events 6 • 7 years, 6 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21 • 7 years, 6 months
|
7.7%
3/39 • Number of events 9 • 7 years, 6 months
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
2/21 • Number of events 2 • 7 years, 6 months
|
17.9%
7/39 • Number of events 17 • 7 years, 6 months
|
|
General disorders
Headache - Pain-Head
|
0.00%
0/21 • 7 years, 6 months
|
17.9%
7/39 • Number of events 10 • 7 years, 6 months
|
|
Nervous system disorders
Speech impairment
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 3 • 7 years, 6 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
10.3%
4/39 • Number of events 4 • 7 years, 6 months
|
|
Gastrointestinal disorders
Stomatitis / pharyngitis
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
10.3%
4/39 • Number of events 5 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/21 • 7 years, 6 months
|
5.1%
2/39 • Number of events 2 • 7 years, 6 months
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
General disorders
Other Toxicity
|
14.3%
3/21 • Number of events 3 • 7 years, 6 months
|
12.8%
5/39 • Number of events 5 • 7 years, 6 months
|
|
Ear and labyrinth disorders
Otitis middle ear
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Extremity pain
|
0.00%
0/21 • 7 years, 6 months
|
5.1%
2/39 • Number of events 2 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/21 • 7 years, 6 months
|
7.7%
3/39 • Number of events 4 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
General disorders
Chest pain
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
General disorders
Pain
|
0.00%
0/21 • 7 years, 6 months
|
5.1%
2/39 • Number of events 2 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
0.00%
0/21 • 7 years, 6 months
|
5.1%
2/39 • Number of events 2 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Vascular disorders
Cerebrovascular accident
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Hypokalemia
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
0.00%
0/39 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
9.5%
2/21 • Number of events 3 • 7 years, 6 months
|
0.00%
0/39 • 7 years, 6 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Nervous system disorders
Seizure(s)
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 2 • 7 years, 6 months
|
|
Gastrointestinal disorders
Weight gain
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
0.00%
0/39 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Edema (Pulmonary)
|
4.8%
1/21 • Number of events 2 • 7 years, 6 months
|
0.00%
0/39 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
0.00%
0/39 • 7 years, 6 months
|
|
General disorders
Rigors
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 2 • 7 years, 6 months
|
|
Nervous system disorders
Neurology - Mood Alteration
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
GI other (Elevated liver enzymes)
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
0.00%
0/39 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Hyperammonemia
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 2 • 7 years, 6 months
|
|
Gastrointestinal disorders
Excessive thirst
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Renal and urinary disorders
Urinary freqency
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
0.00%
0/21 • 7 years, 6 months
|
5.1%
2/39 • Number of events 2 • 7 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Cardiac disorders
Ventricular arrythmia
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Infections and infestations
Infection / Febrile neutropenia
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
0.00%
0/39 • 7 years, 6 months
|
|
Cardiac disorders
Hypotension
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ascites
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Phlebitis (superficial)
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Amylase
|
0.00%
0/21 • 7 years, 6 months
|
2.6%
1/39 • Number of events 1 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Fever & pneumonia
|
4.8%
1/21 • Number of events 1 • 7 years, 6 months
|
0.00%
0/39 • 7 years, 6 months
|
Additional Information
Richard Drachtman, MD
Rutgers Cancer Institute of New Jersey
Phone: 732-235-8675
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place