Trial Outcomes & Findings for Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I (NCT NCT02553460)
NCT ID: NCT02553460
Last Updated: 2025-12-10
Results Overview
Number of treatment related deaths divided by total number of patients during induction or reinduction therapy. Presented as percentage
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
50 participants
Primary outcome timeframe
At the end of reinduction (up to 5 months after start of therapy)
Results posted on
2025-12-10
Participant Flow
Fifty patients were enrolled between January 2016 to November 2021.
Participant milestones
| Measure |
Stratum 1
Patient is \< 365 days of age at the time of diagnosis. Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia with ≥25% blasts in the bone marrow (M3), with or without extramedullary disease. Patients with T-cell ALL are eligible. Patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominantly lymphoid. Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal chemotherapy. Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
Stratum 1
Patient is \< 365 days of age at the time of diagnosis. Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia with ≥25% blasts in the bone marrow (M3), with or without extramedullary disease. Patients with T-cell ALL are eligible. Patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominantly lymphoid. Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal chemotherapy. Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Development of unacceptable toxicity during treatment
|
1
|
|
Overall Study
Relapse or Transplant
|
14
|
|
Overall Study
No response to treatment
|
2
|
|
Overall Study
CAR T cells
|
2
|
Baseline Characteristics
Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I
Baseline characteristics by cohort
| Measure |
Stratum 1
n=50 Participants
Patient is \< 365 days of age at the time of diagnosis. Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia with ≥25% blasts in the bone marrow (M3), with or without extramedullary disease. Patients with T-cell ALL are eligible. Patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominantly lymphoid. Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal chemotherapy. Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines.
|
|---|---|
|
Age, Continuous
|
5.32 months
STANDARD_DEVIATION 3.33 • n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
31 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
15 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
13 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At the end of reinduction (up to 5 months after start of therapy)Number of treatment related deaths divided by total number of patients during induction or reinduction therapy. Presented as percentage
Outcome measures
| Measure |
Stratum 1
n=50 Participants
Patient is \< 365 days of age at the time of diagnosis. Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia with ≥25% blasts in the bone marrow (M3), with or without extramedullary disease. Patients with T-cell ALL are eligible. Patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominantly lymphoid. Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal chemotherapy. Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines.
|
|---|---|
|
Percentage of Treatment-related Mortality (TRM)
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 years after completion of therapy (up to 5 years after start of therapy)Event-free survival (EFS) will be estimated by the Kaplan-Meier estimator. For EFS, relapse and second malignancies will be considered as failures in addition to death in complete remission. The time to EFS will be set to 0 for patients who fail to achieve complete remission. EFS probability will be estimated with 95% confidence intervals.
Outcome measures
| Measure |
Stratum 1
n=50 Participants
Patient is \< 365 days of age at the time of diagnosis. Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia with ≥25% blasts in the bone marrow (M3), with or without extramedullary disease. Patients with T-cell ALL are eligible. Patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominantly lymphoid. Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal chemotherapy. Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines.
|
|---|---|
|
Percentage of Participants With 3-year Event Free Survival (EFS)
|
49.96 percentage of participants
Interval 34.9 to 63.3
|
SECONDARY outcome
Timeframe: 5 years after completion of therapy (up to 7 years after start of therapy)Overall survival (OS) will be estimated by the Kaplan-Meier estimator with 95% confidence intervals.
Outcome measures
| Measure |
Stratum 1
n=50 Participants
Patient is \< 365 days of age at the time of diagnosis. Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia with ≥25% blasts in the bone marrow (M3), with or without extramedullary disease. Patients with T-cell ALL are eligible. Patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominantly lymphoid. Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal chemotherapy. Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines.
|
|---|---|
|
Percentage of Participants With 5-year Overall Survival (OS)
|
62.8 percentage of participants
Interval 46.6 to 75.3
|
SECONDARY outcome
Timeframe: At the end of induction day 22 (approximately 3 weeks), end of induction (approximately 6 weeks), end of consolidation (approximately 14 weeks), and end of maintenance therapy (approximately 2 years)Population: The number analyzed is different from the overall number analyzed because the patient(s) MRD at that time period was not evaluated due to induction failure, death, or relapse.
Proportion of participants with positive MRD at the end of each therapy block. The proportion of MRD positive patients is determined by the number of patients that are MRD positive at the end of each therapy block divided by the number of patients that completed each therapy block.
Outcome measures
| Measure |
Stratum 1
n=49 Participants
Patient is \< 365 days of age at the time of diagnosis. Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia with ≥25% blasts in the bone marrow (M3), with or without extramedullary disease. Patients with T-cell ALL are eligible. Patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominantly lymphoid. Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal chemotherapy. Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines.
|
|---|---|
|
Minimal Residual Disease (MRD) Positivity Using Flow Cytometry or PCR at Induction Day 22, End of Induction, End of Consolidation, and End of Maintenance.
MRD positivity at Day 22
|
13 Participants
|
|
Minimal Residual Disease (MRD) Positivity Using Flow Cytometry or PCR at Induction Day 22, End of Induction, End of Consolidation, and End of Maintenance.
MRD positivity at End of Induction
|
13 Participants
|
|
Minimal Residual Disease (MRD) Positivity Using Flow Cytometry or PCR at Induction Day 22, End of Induction, End of Consolidation, and End of Maintenance.
MRD positivity at End of Consolidation
|
11 Participants
|
|
Minimal Residual Disease (MRD) Positivity Using Flow Cytometry or PCR at Induction Day 22, End of Induction, End of Consolidation, and End of Maintenance.
MRD positivity at End of Maintenance
|
0 Participants
|
Adverse Events
Stratum 1
Serious events: 27 serious events
Other events: 50 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Stratum 1
n=50 participants at risk
Patient is \< 365 days of age at the time of diagnosis. Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia with ≥25% blasts in the bone marrow (M3), with or without extramedullary disease. Patients with T-cell ALL are eligible. Patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominantly lymphoid. Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal chemotherapy. Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.0%
8/50 • Number of events 14 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Cardiac disorders
Cardiac arrest
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Cardiac disorders
Heart failure
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Cardiac disorders
Myocarditis
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Ascites
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Ileal perforation
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Ileus
|
2.0%
1/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Typhlitis
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Catheter related infection
|
12.0%
6/50 • Number of events 11 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
20.0%
10/50 • Number of events 15 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Lung infection
|
8.0%
4/50 • Number of events 11 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Meningitis
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Peritoneal infection
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Rhinitis infective
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Sepsis
|
8.0%
4/50 • Number of events 5 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Skin infection
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Small intestine infection
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Upper respiratory infection
|
8.0%
4/50 • Number of events 6 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Wound infection
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
Neutrophil count decreased
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
Weight loss
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
2.0%
1/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Nervous system disorders
Seizure
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
2/50 • Number of events 3 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
2.0%
1/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
12.0%
6/50 • Number of events 8 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
4.0%
2/50 • Number of events 3 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Vascular disorders
Hypertension
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
General disorders
Fever
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
General disorders
Localized edema
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
Other adverse events
| Measure |
Stratum 1
n=50 participants at risk
Patient is \< 365 days of age at the time of diagnosis. Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia with ≥25% blasts in the bone marrow (M3), with or without extramedullary disease. Patients with T-cell ALL are eligible. Patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominantly lymphoid. Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal chemotherapy. Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
98.0%
49/50 • Number of events 574 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
58.0%
29/50 • Number of events 52 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
8.0%
4/50 • Number of events 4 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Endocrine disorders
Hypothyroidism
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Eye disorders
Conjunctivitis
|
4.0%
2/50 • Number of events 3 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Eye disorders
Eye disorders - Other, specify
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.0%
3/50 • Number of events 4 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Ascites
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Colitis
|
6.0%
3/50 • Number of events 3 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Dental caries
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
26.0%
13/50 • Number of events 18 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
2.0%
1/50 • Number of events 3 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Gastritis
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Ileus
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
12.0%
6/50 • Number of events 7 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Typhlitis
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
6/50 • Number of events 6 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
General disorders
Fatigue
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
General disorders
Fever
|
14.0%
7/50 • Number of events 15 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
6.0%
3/50 • Number of events 3 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
General disorders
Irritability
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
General disorders
Localized edema
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
General disorders
Pain
|
10.0%
5/50 • Number of events 5 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Abdominal infection
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Catheter related infection
|
10.0%
5/50 • Number of events 7 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Enterocolitis infectious
|
28.0%
14/50 • Number of events 19 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
30.0%
15/50 • Number of events 18 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Lung infection
|
14.0%
7/50 • Number of events 15 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Mucosal infection
|
10.0%
5/50 • Number of events 10 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Otitis media
|
14.0%
7/50 • Number of events 9 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Penile infection
|
2.0%
1/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Rhinitis infective
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Sepsis
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Sinusitis
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Skin infection
|
10.0%
5/50 • Number of events 8 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Upper respiratory infection
|
38.0%
19/50 • Number of events 25 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Urinary tract infection
|
14.0%
7/50 • Number of events 9 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Infections and infestations
Wound infection
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.0%
2/50 • Number of events 3 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
Alanine aminotransferase increased
|
80.0%
40/50 • Number of events 150 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
Alkaline phosphatase increased
|
4.0%
2/50 • Number of events 3 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
36.0%
18/50 • Number of events 26 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
Blood bilirubin increased
|
18.0%
9/50 • Number of events 46 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
Cholesterol high
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
Creatinine increased
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
Fibrinogen decreased
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
GGT increased
|
12.0%
6/50 • Number of events 12 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
Investigations - Other, specify
|
2.0%
1/50 • Number of events 14 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
Lipase increased
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
Lymphocyte count decreased
|
96.0%
48/50 • Number of events 878 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
Lymphocyte count increased
|
18.0%
9/50 • Number of events 14 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
Neutrophil count decreased
|
100.0%
50/50 • Number of events 927 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
Platelet count decreased
|
100.0%
50/50 • Number of events 832 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
Weight gain
|
4.0%
2/50 • Number of events 9 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
Weight loss
|
14.0%
7/50 • Number of events 11 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Investigations
White blood cell decreased
|
100.0%
50/50 • Number of events 1138 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
16.0%
8/50 • Number of events 39 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Alkalosis
|
6.0%
3/50 • Number of events 3 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
36.0%
18/50 • Number of events 24 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
5/50 • Number of events 5 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.0%
8/50 • Number of events 13 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
5/50 • Number of events 6 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.0%
3/50 • Number of events 5 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.0%
3/50 • Number of events 3 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
28.0%
14/50 • Number of events 43 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
6.0%
3/50 • Number of events 7 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
28.0%
14/50 • Number of events 23 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
34.0%
17/50 • Number of events 48 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
16.0%
8/50 • Number of events 13 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
54.0%
27/50 • Number of events 92 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.0%
2/50 • Number of events 3 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
30.0%
15/50 • Number of events 22 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.0%
6/50 • Number of events 10 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
12.0%
6/50 • Number of events 6 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Nervous system disorders
Movements involuntary
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Nervous system disorders
Neuralgia
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.0%
3/50 • Number of events 3 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Nervous system disorders
Seizure
|
6.0%
3/50 • Number of events 3 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Psychiatric disorders
Delirium
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Renal and urinary disorders
Hematuria
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Renal and urinary disorders
Proteinuria
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.0%
4/50 • Number of events 4 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/50 • Number of events 4 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
4.0%
2/50 • Number of events 3 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
4.0%
2/50 • Number of events 4 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
2.0%
1/50 • Number of events 1 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
8.0%
4/50 • Number of events 4 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
20.0%
10/50 • Number of events 10 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Vascular disorders
Hematoma
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Vascular disorders
Hypertension
|
54.0%
27/50 • Number of events 45 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Vascular disorders
Hypotension
|
4.0%
2/50 • Number of events 2 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
|
Vascular disorders
Thromboembolic event
|
6.0%
3/50 • Number of events 3 • Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
|
Additional Information
Tanja A. Gruber, MD, PhD
Lucile Packard Children's Hospital
Phone: (650) 723-5535
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee MSA states Site is unable to publish until all completed case report forms have been delivered to Sponsor, (Study Completion). Site shall have the right to publish after publication of a multi-center publication coordinated by the Sponsor or (12) mths. after Study Completion; provided, that prior to any such publication or public release of such data, Site shall furnish Sponsor with a copy of any proposed publication at least (45)days in advance of the proposed publication or presentation date.
- Publication restrictions are in place
Restriction type: OTHER