Trial Outcomes & Findings for Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia (NCT NCT00137111)
NCT ID: NCT00137111
Last Updated: 2020-09-11
Results Overview
EFS was measured from the start of on-study to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Failure to enter remission was considered an event at time zero. Measurement was determined by Kaplan-Meyer estimate.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
501 participants
Primary outcome timeframe
Median follow-up time (range) 5.6 (1.3 to 8.9) years
Results posted on
2020-09-11
Participant Flow
501 patients were recruited between June 2000 and October 2007.
501 patients were enrolled on the study. 3 patients were determined to be ineligible shortly after enrollment (wrong diagnosis - AML or CML in blast crisis).498 patients started the study.
Participant milestones
| Measure |
Total Therapy
Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy.
|
4 hr
4 hour High-Dose Methotrexate Infusion in upfront window treatment
|
24 hr
24 hour High-Dose Methotrexate Infusion in upfront window treatment
|
Non Randomized
Patients not randomized for window study
|
|---|---|---|---|---|
|
Window Therapy
STARTED
|
0
|
176
|
180
|
142
|
|
Window Therapy
COMPLETED
|
0
|
176
|
180
|
142
|
|
Window Therapy
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Total Therapy
STARTED
|
498
|
0
|
0
|
0
|
|
Total Therapy
COMPLETED
|
458
|
0
|
0
|
0
|
|
Total Therapy
NOT COMPLETED
|
40
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Total Therapy
Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy.
|
4 hr
4 hour High-Dose Methotrexate Infusion in upfront window treatment
|
24 hr
24 hour High-Dose Methotrexate Infusion in upfront window treatment
|
Non Randomized
Patients not randomized for window study
|
|---|---|---|---|---|
|
Total Therapy
Death
|
35
|
0
|
0
|
0
|
|
Total Therapy
Non Compliance
|
5
|
0
|
0
|
0
|
Baseline Characteristics
Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Total Therapy
n=498 Participants
Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy.
|
4 hr
4 hour High-Dose Methotrexate Infusion in upfront window treatment
|
24 hr
24 hour High-Dose Methotrexate Infusion in upfront window treatment
|
Non Randomized
Patients not randomized for window study
|
Total
n=498 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
1 to 9 years
|
372 participants
n=93 Participants
|
—
|
—
|
—
|
372 participants
n=36 Participants
|
|
Age, Customized
>=10 years
|
126 participants
n=93 Participants
|
—
|
—
|
—
|
126 participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
219 Participants
n=93 Participants
|
—
|
—
|
—
|
219 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
279 Participants
n=93 Participants
|
—
|
—
|
—
|
279 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Median follow-up time (range) 5.6 (1.3 to 8.9) yearsPopulation: 498 enrolled patients were eligible for analysis to estimate the overall event-free survival of children at least one year of age at diagnosis who are treated with risk-directed therapy.
EFS was measured from the start of on-study to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Failure to enter remission was considered an event at time zero. Measurement was determined by Kaplan-Meyer estimate.
Outcome measures
| Measure |
Total Therapy
n=498 Participants
Total therapy applies to all eligible patients.
|
24 hr
24 hour High-Dose Methotrexate Infusion in upfront window treatment
|
|---|---|---|
|
Overall Event-free Survival (EFS)
|
87.3 Percentage of Participants
Interval 0.831 to 0.901
|
—
|
PRIMARY outcome
Timeframe: Median follow up time (range) 4.5 (1 to 7.8) yearsPopulation: Patients meeting the following high risk CNS Relapse criteria: white cell blood cell count at diagnosis more than 100,000; Philadelphia Chromosome Positive; CNS 3 at diagnosis; T-Lineage with white blood cell count more than 50,000.
CCR was measured from end of week 56 therapy to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Measurement was determined by Kaplan-Meyer estimate.
Outcome measures
| Measure |
Total Therapy
n=70 Participants
Total therapy applies to all eligible patients.
|
24 hr
24 hour High-Dose Methotrexate Infusion in upfront window treatment
|
|---|---|---|
|
Continuous Complete Remission Since Week 56 Therapy.
|
92.2 Percentage of participants
Interval 82.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: End of Induction (Day 46 MRD measurement)Population: Patients who completed induction and had successful MRD studies on day 46.
Detection of MRD at end of induction where positive MRD was defined as one or more leukemic cell per 10,000 mononuclear bone-marrow cells (\>=0.01%).
Outcome measures
| Measure |
Total Therapy
n=492 Participants
Total therapy applies to all eligible patients.
|
24 hr
24 hour High-Dose Methotrexate Infusion in upfront window treatment
|
|---|---|---|
|
Minimal Residual Disease (MRD)
Negative <0.01%
|
390 participants
|
—
|
|
Minimal Residual Disease (MRD)
Positive >= 0.01%
|
102 participants
|
—
|
SECONDARY outcome
Timeframe: 42 hours after start of high dose methotrexate infusion (HDMTX)Population: The 286 patients randomized to treatment with high-dose methotrexate (HDMTX) who had methotrexate polyglutamate (MTXPG) concentration measured in bone marrow ALL cells .
Children were randomly assigned to receive initial single-agent treatment with HDMTX (1g/m\^2) as either a 24-hour infusion or a 4-hour infusion and the outcome measure was the accumulation of MTXPG in leukemia cells.
Outcome measures
| Measure |
Total Therapy
n=136 Participants
Total therapy applies to all eligible patients.
|
24 hr
n=150 Participants
24 hour High-Dose Methotrexate Infusion in upfront window treatment
|
|---|---|---|
|
Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours).
|
1688 pmol/1,000,000,000 cells
Standard Deviation 2015
|
2521 pmol/1,000,000,000 cells
Standard Deviation 2950
|
SECONDARY outcome
Timeframe: Immediately before the methotrexate infusion and three days after subsequent infusionPopulation: Three hundred twenty (320) patients were evaluable to assess the influence of infusion duration on methotrexate's antileukemic effects.
White blood cell (leukocytes) counts in peripheral blood by Complete Blood Count Measurement: Percentage change of leukemia cells from baseline
Outcome measures
| Measure |
Total Therapy
n=156 Participants
Total therapy applies to all eligible patients.
|
24 hr
n=164 Participants
24 hour High-Dose Methotrexate Infusion in upfront window treatment
|
|---|---|---|
|
Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours)
|
-44 Percent change
Standard Deviation 42.2
|
-50 Percent change
Standard Deviation 35.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatmentPopulation: One hundred forty-four (144) patients were evaluable to assess prednisolone sensitivity measured in bone marrow ALL cells and CASP1 expression in RNA by MTT assay.
Prednisolone sensitivity was measured in primary leukemia cells from bone marrow collected at diagnosis. Expression of CASP1 was determined by HG-U133A microarray. Values given are gene expression values, and the unit is arbitrary units (AU) defined as scaled fluorescence measured on microarray.
Outcome measures
| Measure |
Total Therapy
n=144 Participants
Total therapy applies to all eligible patients.
|
24 hr
24 hour High-Dose Methotrexate Infusion in upfront window treatment
|
|---|---|---|
|
Median Difference in CASP1 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs Glucocorticoid-sensitive Cells
Prednisolone-sensitive cells
|
341.3 arbitrary units
Interval 202.1 to 430.2
|
—
|
|
Median Difference in CASP1 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs Glucocorticoid-sensitive Cells
Prednisolone-resistant cells
|
447.9 arbitrary units
Interval 332.2 to 544.9
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatmentPopulation: One hundred forty-four (144) patients were evaluable to assess prednisolone sensitivity measured in bone marrow ALL cells and NLRP3 expression in RNA by MTT assay
Prednisolone sensitivity was measured in primary leukemia cells from bone marrow collected at diagnosis. Expression of NLRP3 was determined by HG-U133A microarray. Values given are gene expression values, and the unit is arbitrary units (AU) defined as scaled fluorescence measured on microarray.
Outcome measures
| Measure |
Total Therapy
n=144 Participants
Total therapy applies to all eligible patients.
|
24 hr
24 hour High-Dose Methotrexate Infusion in upfront window treatment
|
|---|---|---|
|
Median Difference in NLRP3 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs. Glucocorticoid-sensitive Cells
Prednisolone-sensitive cells
|
41.2 arbitrary units
Interval 31.4 to 58.7
|
—
|
|
Median Difference in NLRP3 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs. Glucocorticoid-sensitive Cells
Prednisolone-resistant cells
|
110.7 arbitrary units
Interval 59.7 to 157.6
|
—
|
Adverse Events
Total Therapy
Serious events: 74 serious events
Other events: 468 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Total Therapy
n=498 participants at risk
Total therapy applies to all eligible patients.
|
|---|---|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
0.40%
2/498 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome (ARDS)
|
2.2%
11/498 • Number of events 11 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Immune system disorders
Allergic Reaction to Asparaginase
|
1.2%
6/498 • Number of events 6 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.40%
2/498 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Metabolism and nutrition disorders
Amylase
|
0.20%
1/498 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.40%
2/498 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Hepatobiliary disorders
Bilirubin
|
0.20%
1/498 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Blood and lymphatic system disorders
CNS hemorrhage/bleeding
|
0.40%
2/498 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Infections and infestations
Catheter-related infection
|
0.60%
3/498 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Gastrointestinal disorders
Colitis
|
0.80%
4/498 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Renal and urinary disorders
Creatinine
|
0.20%
1/498 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Blood and lymphatic system disorders
DIC (disseminated intravascular coagulation)
|
0.40%
2/498 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other
|
0.20%
1/498 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.40%
2/498 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
General disorders
Edema
|
0.40%
2/498 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Infections and infestations
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
|
0.60%
3/498 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
|
0.60%
3/498 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Blood and lymphatic system disorders
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
|
0.20%
1/498 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Hepatobiliary disorders
Hepatic-Other
|
0.20%
1/498 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.20%
1/498 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.20%
1/498 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Cardiac disorders
Hypertension
|
0.40%
2/498 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Cardiac disorders
Hypotension
|
1.8%
9/498 • Number of events 9 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
10/498 • Number of events 10 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e
|
6.4%
32/498 • Number of events 32 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Infections and infestations
Infection without neutropenia
|
1.0%
5/498 • Number of events 5 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Nervous system disorders
Leukoencephalopathy associated with radiological findings
|
0.40%
2/498 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Metabolism and nutrition disorders
Lipase
|
0.20%
1/498 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical),
|
0.40%
2/498 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Nervous system disorders
Neuropathy-sensory
|
0.20%
1/498 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.40%
2/498 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Psychiatric disorders
Personality/behavioral
|
0.20%
1/498 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.80%
4/498 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.60%
3/498 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-Other
|
0.20%
1/498 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Gastrointestinal disorders
Renal failure
|
0.80%
4/498 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Nervous system disorders
Seizure(s)
|
1.2%
6/498 • Number of events 6 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Cardiac disorders
Sinus tachycardia
|
0.20%
1/498 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Cardiac disorders
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
|
0.20%
1/498 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Cardiac disorders
Thrombosis/embolism
|
1.0%
5/498 • Number of events 5 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Gastrointestinal disorders
Typhlitis (inflammation of cecum)
|
0.40%
2/498 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Eye disorders
Vision-blurred vision
|
0.20%
1/498 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
1/498 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
Other adverse events
| Measure |
Total Therapy
n=498 participants at risk
Total therapy applies to all eligible patients.
|
|---|---|
|
General disorders
Abdominal pain or cramping
|
9.4%
47/498 • Number of events 69 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Immune system disorders
Allergic Reaction to Asparaginase
|
8.2%
41/498 • Number of events 45 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Gastrointestinal disorders
Anorexia
|
5.2%
26/498 • Number of events 31 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Infections and infestations
Catheter-related infection
|
17.3%
86/498 • Number of events 131 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Gastrointestinal disorders
Dehydration
|
5.8%
29/498 • Number of events 36 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
10.6%
53/498 • Number of events 62 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Infections and infestations
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
|
87.6%
436/498 • Number of events 1407 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
|
41.8%
208/498 • Number of events 403 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
General disorders
Headache
|
5.2%
26/498 • Number of events 38 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.6%
43/498 • Number of events 62 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Cardiac disorders
Hypertension
|
8.4%
42/498 • Number of events 42 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.4%
32/498 • Number of events 36 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Cardiac disorders
Hypotension
|
10.4%
52/498 • Number of events 53 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.2%
51/498 • Number of events 62 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia
|
76.1%
379/498 • Number of events 893 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Infections and infestations
Infection without neutropenia
|
58.2%
290/498 • Number of events 594 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Nervous system disorders
Neuropathic pain
|
9.2%
46/498 • Number of events 46 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
7.0%
35/498 • Number of events 60 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
25/498 • Number of events 25 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
5.8%
29/498 • Number of events 33 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Hepatobiliary disorders
SGPT (ALT)
|
15.3%
76/498 • Number of events 100 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis),
|
13.1%
65/498 • Number of events 75 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Cardiac disorders
Thrombosis/embolism
|
6.2%
31/498 • Number of events 34 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Gastrointestinal disorders
Typhlitis
|
5.4%
27/498 • Number of events 37 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
59/498 • Number of events 67 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
|
Skin and subcutaneous tissue disorders
Wound-infectious
|
8.6%
43/498 • Number of events 48 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place