Trial Outcomes & Findings for Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia (NCT NCT00003910)

Last Updated: 2023-07-05

Results Overview

We will report the overall response rate below. Complete remission requires that all of the following be present for at least four weeks: The patient must have a normal CBC including neutrophil count \> 1500/mm3, lymphocyte count\< 4000/mm3, hemoglobin \> 11 g/dl, and platelet count \> 100,000/mm3. In addition, the patient must have a normal LGL count. A complete response will be attained if CD8+ cells were less than 760/mm³. A partial response will be defined as achievement of any one of the following in the absence of CR. The response must last for at least four weeks:In patients being treated for severe neutropenia (less than 500 neutrophils/mm3) an improvement to over 500 neutrophils/mm3 will be considered a partial response, as long as that improvement represents at least a 50% improvement.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

59 participants

Primary outcome timeframe

Assessed during the first 4 months, then at least every three months for two years. Then every six months until five years after study entry, and every 12 months thereafter until full study stop date.

Results posted on

2023-07-05

Participant Flow

This study accrued 59 patients between July 16, 1999 and March 24, 2009. The first patient was accrued on September 15, 1999. The study terminated with 59 patients on March 24, 2009 due to slower than expected accrual.

Participant milestones

Participant milestones
Measure	Methotrexate MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. If patient had a partial response, MTX was continued for up to 1 year. If patient had CR, MTX was continued for 1 month. If no response, then pt went onto step 2 and received CY.	Cyclophosphomide Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
Step 1 STARTED	55	0
Step 1 COMPLETED	55	0
Step 1 NOT COMPLETED	0	0
Step 2 STARTED	0	16
Step 2 COMPLETED	0	16
Step 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Methotrexate n=55 Participants MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	35 Participants n=5 Participants
Age, Continuous	65.4 years STANDARD_DEVIATION 17.8 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed during the first 4 months, then at least every three months for two years. Then every six months until five years after study entry, and every 12 months thereafter until full study stop date.

Population: Of the 59 pts, 4 were ineligible and excluded from the analysis.

Outcome measures

Outcome measures
Measure	Methotrexate n=55 Participants MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
Proportion of Patients With Complete or Partial Response to Treatment With MTX	0.39 proportion of participants Interval 0.26 to 0.53

SECONDARY outcome

Timeframe: Assessed during the first 4 months of treatment and followed until reaching full study stop date

Population: Eligible patients who received Cy after failing to respond to MTX are included in this analysis.

Outcome measures

Outcome measures
Measure	Methotrexate n=14 Participants MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
Proportion of Patients With Complete or Partial Response to Treatment of CY Among Patients Failing to Respond to MTX	0.64 proportion of participants Interval 0.35 to 0.87

Adverse Events

Methotrexate

Serious events: 56 serious events

Other events: 56 other events

Deaths: 0 deaths

Cyclophosphamide

Serious events: 8 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Statistician

ECOG Statistical Office

Phone: 617-632-3012

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Methotrexate n=59 participants at risk MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.	Cyclophosphamide n=16 participants at risk step 2 patients who received CY
Blood and lymphatic system disorders Anemia	22.0% 13/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	31.2% 5/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Musculoskeletal and connective tissue disorders Arthralgia	1.7% 1/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
General disorders Cough	1.7% 1/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Blood and lymphatic system disorders Creatinine	1.7% 1/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.7% 1/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	6.2% 1/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
General disorders Fatigue	8.5% 5/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Blood and lymphatic system disorders Hemmorhage	1.7% 1/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Blood and lymphatic system disorders Hyperglycemia	10.2% 6/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	12.5% 2/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Cardiac disorders Hypertension	1.7% 1/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Metabolism and nutrition disorders Hyponatremia	3.4% 2/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Metabolism and nutrition disorders Hypoxia	3.4% 2/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Infections and infestations Infection with grade 3 or 4 neutropenia	10.2% 6/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Infections and infestations Infection without neutropenia	5.1% 3/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Blood and lymphatic system disorders Leukopenia	16.9% 10/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	37.5% 6/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Blood and lymphatic system disorders Lymphopenia	8.5% 5/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	43.8% 7/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Musculoskeletal and connective tissue disorders Muscle weakness	1.7% 1/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Gastrointestinal disorders Nausea	1.7% 1/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Blood and lymphatic system disorders Neutropenia	50.8% 30/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	37.5% 6/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Respiratory, thoracic and mediastinal disorders Pneumonitis	8.5% 5/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	6.2% 1/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Skin and subcutaneous tissue disorders Rash	1.7% 1/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Blood and lymphatic system disorders Thrombocytopenia	10.2% 6/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	6.2% 1/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Gastrointestinal disorders Melena/GI bleeding	0.00% 0/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	6.2% 1/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Psychiatric disorders Depressed level of consciousness	0.00% 0/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	6.2% 1/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Cardiac disorders Cardiac-left ventricular function	0.00% 0/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	6.2% 1/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	6.2% 1/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Renal and urinary disorders Hematuria	0.00% 0/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	6.2% 1/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.

Measure	Methotrexate n=59 participants at risk MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.	Cyclophosphamide n=16 participants at risk step 2 patients who received CY
Metabolism and nutrition disorders AST increased	35.6% 21/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Metabolism and nutrition disorders Alkaline Phosphatase Increased	15.3% 9/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Blood and lymphatic system disorders Anemia	69.5% 41/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	31.2% 5/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Metabolism and nutrition disorders Anorexia	18.6% 11/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Metabolism and nutrition disorders Bilirubin Increased	25.4% 15/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Gastrointestinal disorders Constipation	6.8% 4/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Metabolism and nutrition disorders Creatinine	18.6% 11/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Gastrointestinal disorders Diarrhea	8.5% 5/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Respiratory, thoracic and mediastinal disorders Dyspnea	18.6% 11/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	6.2% 1/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Metabolism and nutrition disorders Edema	8.5% 5/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
General disorders Fatigue	57.6% 34/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
General disorders Fever	13.6% 8/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Metabolism and nutrition disorders Hyperglycemia	57.6% 34/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	18.8% 3/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Metabolism and nutrition disorders Hypoalemia	15.3% 9/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Metabolism and nutrition disorders Hypoglycemia	11.9% 7/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Metabolism and nutrition disorders Hypokalemia	15.3% 9/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Metabolism and nutrition disorders Hyponatremia	23.7% 14/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Infections and infestations Infection with grade 3 or 4 neutropenia	11.9% 7/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
General disorders Insomnia	16.9% 10/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Blood and lymphatic system disorders Leukopenia	62.7% 37/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	37.5% 6/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Gastrointestinal disorders Nausea	23.7% 14/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Blood and lymphatic system disorders Neutropenia	83.1% 49/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	37.5% 6/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Gastrointestinal disorders Stomatitis	16.9% 10/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	0.00% 0/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Blood and lymphatic system disorders Thrombocytopenia	33.9% 20/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	6.2% 1/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Cardiac disorders Cardiac-left ventricular function	0.00% 0/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	6.2% 1/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Gastrointestinal disorders Melena/GI bleeding	0.00% 0/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	6.2% 1/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Psychiatric disorders Depressed level of consciousness	0.00% 0/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	6.2% 1/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	6.2% 1/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.
Infections and infestations Infection with unknown ANC	0.00% 0/59 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.	6.2% 1/16 • Assessed every 30 days while on treatment and for 30 days after the end of treatment. Here we look at all patients, all 59, whereas we excluded the ineligible patients from the baseline tables etc (n=55) as is standard to do in our final reports for ECOG.