Trial Outcomes & Findings for Daunorubicin & Cytarabine +/- Zosuquidar inTreating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia (NCT NCT00046930)

NCT ID: NCT00046930

Last Updated: 2023-07-05

Results Overview

Time from randomization to death. Patients alive at last follow-up were censored.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 449 participants
• Primary outcome timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter
• Results posted on: 2023-07-05

Participant Flow

The first patient was accrued on September 17, 2002.

Participant milestones

Measure	Zosuquidar Induction treatment with daunorubicin, cytarabine and zosuquidar	Placebo Induction treatment with daunorubicin, cytarabine and placebo
Overall Study STARTED	224	225
Overall Study COMPLETED	212	221
Overall Study NOT COMPLETED	12	4

Reasons for withdrawal

Measure	Zosuquidar Induction treatment with daunorubicin, cytarabine and zosuquidar	Placebo Induction treatment with daunorubicin, cytarabine and placebo
Overall Study Ineligible	12	4

Baseline Characteristics

Daunorubicin & Cytarabine +/- Zosuquidar inTreating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia

Baseline characteristics by cohort

Measure	Zosuquidar n=212 Participants Induction treatment with daunorubicin, cytarabine and zosuquidar	Placebo n=221 Participants Induction treatment with daunorubicin, cytarabine and placebo	Total n=433 Participants Total of all reporting groups
Age, Continuous	69.4 years STANDARD_DEVIATION 5.5 • n=5 Participants	69.2 years STANDARD_DEVIATION 5.3 • n=7 Participants	69.3 years STANDARD_DEVIATION 5.4 • n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants	85 Participants n=7 Participants	188 Participants n=5 Participants
Sex: Female, Male Male	109 Participants n=5 Participants	136 Participants n=7 Participants	245 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter

Population: Eligible participants, as randomized

Time from randomization to death. Patients alive at last follow-up were censored.

Outcome measures

Measure	Zosuquidar n=212 Participants Induction treatment with daunorubicin, cytarabine and zosuquidar	Placebo n=221 Participants Induction treatment with daunorubicin, cytarabine and placebo
Overall Survival (OS)	7.23 Months Interval 5.62 to 10.58	9.43 Months Interval 8.02 to 10.71

SECONDARY outcome

Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter

Population: Eligible participants, as randomized. Patients who had neither documented progression nor death within 3 months of registration without disease evaluation were excluded.

Time from randomization to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.

Outcome measures

Measure	Zosuquidar n=202 Participants Induction treatment with daunorubicin, cytarabine and zosuquidar	Placebo n=211 Participants Induction treatment with daunorubicin, cytarabine and placebo
Progression-free Survival (PFS)	3.02 Months Interval 2.04 to 3.84	2.04 Months Interval 1.64 to 3.45

SECONDARY outcome

Timeframe: Assessed at the end of induction

Number of eligible participants in each response category. Categories, based on peripheral blood counts and bone marrow aspirate and biopsy, include complete remission (CR), partial remission (PR), morphologic complete remission (MCR), and relapse.

Outcome measures

Measure	Zosuquidar n=212 Participants Induction treatment with daunorubicin, cytarabine and zosuquidar	Placebo n=221 Participants Induction treatment with daunorubicin, cytarabine and placebo
Response Complete Remission	98 Participants	96 Participants
Response Morphologic Complete Remission	12 Participants	12 Participants
Response Partial Remission	2 Participants	0 Participants
Response Relapse	67 Participants	90 Participants
Response Unevaluable	33 Participants	23 Participants

Adverse Events

Zosuquidar Induction

Serious events: 216 serious events

Other events: 218 other events

Deaths: 0 deaths

Placebo Induction

Serious events: 218 serious events

Other events: 221 other events

Deaths: 0 deaths

Consolidation I

Serious events: 173 serious events

Other events: 180 other events

Deaths: 0 deaths

Zosuquidar Consolidation II

Serious events: 59 serious events

Other events: 59 other events

Deaths: 0 deaths

Placebo Consolidation II

Serious events: 69 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Measure	Zosuquidar Induction n=219 participants at risk Induction treatment with daunorubicin, cytarabine and zosuquidar	Placebo Induction n=222 participants at risk Induction treatment with daunorubicin, cytarabine and placebo	Consolidation I n=180 participants at risk Cytarabine 1500 mg/m2 days 1-6	Zosuquidar Consolidation II n=59 participants at risk Consolidation with Daunorubicin, Cytarabine and Zosuquidar	Placebo Consolidation II n=70 participants at risk Consolidation with Daunorubicin, Cytarabine and Placebo
Blood and lymphatic system disorders Lymphopenia	1.4% 3/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.3% 5/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 3/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.9% 2/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Bone Marrow Hypocellularity	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Anemia	73.1% 160/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	68.5% 152/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	52.2% 94/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	54.2% 32/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	52.9% 37/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Hemolysis	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Leukopenia	93.6% 205/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	95.0% 211/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	92.8% 167/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	98.3% 58/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	94.3% 66/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Neutropenia	91.3% 200/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	91.0% 202/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	85.0% 153/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	81.4% 48/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	87.1% 61/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Thrombocytopenia	95.9% 210/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	96.4% 214/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	93.9% 169/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	81.4% 48/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	87.1% 61/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Transfusion: Platelets	9.1% 20/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	10.4% 23/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	11.1% 20/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	8.5% 5/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	14.3% 10/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Transfusion: Peripheral Red Blood Cells	8.2% 18/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	8.1% 18/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	8.3% 15/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.8% 4/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	11.4% 8/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Hematologic - Other	0.91% 2/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Cardiac disorders Conduction Abnormality	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Cardiac disorders Dysrhythmia	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Cardiac disorders Sinus Bradycardia	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Cardiac disorders Sinus Tachycardia	1.8% 4/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.3% 5/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.1% 2/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Cardiac disorders Supraventricular Arrhythmia	7.3% 16/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.6% 8/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.2% 4/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Cardiac disorders Ventricular Arrhythmia	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Cardiac disorders Arrhythmia - Other	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Cardiac disorders Cardiac Ischemia	1.8% 4/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.90% 2/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Cardiac disorders Cardiac - Left Ventricular Dysfunction	2.7% 6/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.6% 8/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 3/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.4% 2/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Cardiac disorders Cardiac Troponin I Increased	0.91% 2/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.90% 2/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Cardiac disorders Cardiac Troponin T Increased	0.91% 2/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Cardiac disorders Acute Vascular Leak Syndrome	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Cardiac disorders Hypertension	1.4% 3/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.2% 7/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Cardiac disorders Edema	2.7% 6/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Cardiac disorders Hypotension	7.3% 16/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	4.1% 9/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.1% 2/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Vascular disorders Thrombosis/Embolism	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.90% 2/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Cardiac disorders Cardiac, Other	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
General disorders Fatigue	17.4% 38/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	9.9% 22/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	4.4% 8/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.8% 4/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.9% 2/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
General disorders Fever w/o neutropenia	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
General disorders Rigors/Chills	0.91% 2/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
General disorders Constitutional, Other	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Disseminated Intravascular Coagulation	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Thrombotic Microangiopathy	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Fibrinogen Decreased	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.90% 2/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Prolonged Partial Thromboplastin Time	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations PT (INR) Increased	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.90% 2/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Skin and subcutaneous tissue disorders Pruritis/itching	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Skin and subcutaneous tissue disorders Rash/Desquamation	4.6% 10/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.8% 4/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.1% 2/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Skin and subcutaneous tissue disorders Wound, Infectious	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.90% 2/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.1% 2/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Endocrine disorders Neuroendocrine: ADH Secretion Abnormality	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Anorexia	13.2% 29/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	9.0% 20/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.8% 5/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.1% 3/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.7% 4/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Ascites	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Colitis	2.3% 5/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 3/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 3/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.9% 2/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Constipation	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Dehydration	1.8% 4/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Heartburn/Dyspepsia	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Dysphagia	4.6% 10/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.90% 2/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Ulcer, Gastric	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Nausea	8.2% 18/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.4% 12/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 3/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Pancreatitis	0.91% 2/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Stomatitis	8.7% 19/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.0% 11/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 3/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.1% 3/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.9% 2/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Typhlitis	1.4% 3/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.90% 2/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Vomiting	2.7% 6/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.90% 2/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Diarrhea w/o Prior Colostomy	7.3% 16/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.9% 13/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.8% 5/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.8% 4/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.7% 4/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Diarrhea w/Colostomy	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders GI, Other	1.8% 4/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.90% 2/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Injury, poisoning and procedural complications Hemorrhage, Other	5.5% 12/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 3/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.2% 4/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	4.3% 3/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Respiratory, thoracic and mediastinal disorders Hemorrhage, Upper Respiratory, Nose	5.5% 12/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.9% 13/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.1% 2/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.4% 2/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.7% 4/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Hemorrhage, GI, Hematemesis	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Hemorrhage, GU, Hematuria	1.4% 3/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 3/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Hemorrhage, Upper Respiratory, Hemoptysis	0.91% 2/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Hemorrhage Associated with Surgery	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Hemorrhage, GI, Melena	2.3% 5/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.8% 4/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	4.3% 3/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Petechiae	3.2% 7/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.9% 13/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	4.4% 8/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.7% 4/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Hemorrhage, GI, Rectum	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Alkaline Phosphatase Increased	0.91% 2/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.8% 4/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Bilirubin Increased	16.4% 36/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	14.0% 31/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.1% 2/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.8% 4/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Gamma-glutamyl Transpeptidase (GGT) Increased	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Hypoalbuminemia	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Hepatobiliary disorders Liver Dysfunction/Failure	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Hemorrhage, GU, Vagina	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations ALT, SGPT Increased	2.3% 5/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.6% 8/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.1% 2/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations AST, SGOT Increased	3.7% 8/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.0% 11/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.1% 2/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.9% 2/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Hepatobiliary disorders Hepatic, Other	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Infections and infestations Infection, Catheter Related	2.3% 5/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.6% 8/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.1% 2/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.4% 2/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	4.3% 3/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Infections and infestations Febrile Neutropenia	42.5% 93/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	36.9% 82/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	23.3% 42/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	20.3% 12/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	21.4% 15/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Infections and infestations Infection w/ Grade 3 or 4 Neutropenia	54.3% 119/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	54.5% 121/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	31.7% 57/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	49.2% 29/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	37.1% 26/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Infections and infestations Infection w/ Unknown ANC	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 3/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.1% 2/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Infections and infestations Infection without Neutropenia	3.7% 8/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.2% 7/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	9.4% 17/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.1% 3/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.7% 4/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Infections and infestations Infection, Other	0.91% 2/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.90% 2/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Lymphatics, Other	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Acidosis	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 3/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Alkalosis	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Amylase Increased	0.91% 2/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Bicarbonate, Serum Decreased	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Hyperglycemia	3.2% 7/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 3/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.1% 2/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Hyperkalemia	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Hypermagnesemia	1.4% 3/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.90% 2/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Hypernatremia	0.91% 2/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Hyperuricemia	1.8% 4/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Hypocalcemia	7.8% 17/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.2% 7/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Hypoglycemia	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Hypokalemia	7.3% 16/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.4% 12/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 3/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	10.2% 6/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Hypomagnesemia	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Hyponatremia	5.0% 11/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 3/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 3/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.4% 2/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Hypophosphatemia	5.9% 13/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.8% 4/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 3/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.4% 2/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Lipase Increased	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Muscle Weakness	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Ataxia	7.8% 17/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.90% 2/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.8% 5/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.4% 2/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Cerebrovascular Ischemia	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Confusion	8.2% 18/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 3/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.1% 3/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Psychosis (Hallucinations/Delusions)	11.0% 24/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	4.5% 10/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.1% 2/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Somnolence/Depressed Level of Consciousness	3.7% 8/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.8% 4/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Dizziness/Lightheadedness	1.4% 3/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.1% 2/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Insomnia	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Memory Impairment	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Mood Alteration: Anxiety/Agitation	1.4% 3/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Mood Alteration: Depression	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Neuropathy, Motor	1.8% 4/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.90% 2/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Neuropathy, Sensory	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Seizure	0.91% 2/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Speech Impairment	1.8% 4/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Pyramidal Tract Dysfunction	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Syncope	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.1% 2/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Tremor	2.3% 5/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Neurologic - Other	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Eye disorders Conjunctivitis	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Eye disorders Vision - Blurred	0.91% 2/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Eye disorders Nystagmus	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Pain, Abdomen	3.7% 8/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.3% 5/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Musculoskeletal and connective tissue disorders Pain, Joint (Arthralgia)	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Musculoskeletal and connective tissue disorders Pain, Bone	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Pain, Headache	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.90% 2/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.1% 2/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Musculoskeletal and connective tissue disorders Pain, Muscle (Myalgia)	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Respiratory, thoracic and mediastinal disorders Pain, Pleura	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.90% 2/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Pain, Rectum	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
General disorders Pain, Other	1.4% 3/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Respiratory, thoracic and mediastinal disorders Adult Respiratory Distress Syndrome (ARDS)	1.8% 4/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 22/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	9.5% 21/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 3/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.3% 16/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.4% 12/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.1% 2/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Respiratory, thoracic and mediastinal disorders Pneumonitis/Pulmonary Infiltrates	5.9% 13/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.0% 11/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.1% 2/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.9% 2/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Respiratory, thoracic and mediastinal disorders Voice changes/Dysarthria	0.91% 2/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.90% 2/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Respiratory, thoracic and mediastinal disorders Pulmonary, Other	1.8% 4/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.8% 4/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Renal and urinary disorders Renal, Other - Dysuria	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Renal and urinary disorders Incontinence, Urinary	0.91% 2/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Proteinuria	0.46% 1/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Renal and urinary disorders Renal Failure	1.8% 4/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.8% 4/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Renal and urinary disorders Urinary Frequency/Urgency	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Renal and urinary disorders Urinary Retention	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Renal and urinary disorders Renal, Other	0.91% 2/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Metabolism and nutrition disorders Tumor Lysis Syndrome	2.7% 6/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Eye disorders Keratitis	0.00% 0/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.

Other adverse events

Measure	Zosuquidar Induction n=219 participants at risk Induction treatment with daunorubicin, cytarabine and zosuquidar	Placebo Induction n=222 participants at risk Induction treatment with daunorubicin, cytarabine and placebo	Consolidation I n=180 participants at risk Cytarabine 1500 mg/m2 days 1-6	Zosuquidar Consolidation II n=59 participants at risk Consolidation with Daunorubicin, Cytarabine and Zosuquidar	Placebo Consolidation II n=70 participants at risk Consolidation with Daunorubicin, Cytarabine and Placebo
Blood and lymphatic system disorders Anemia	95.9% 210/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	96.8% 215/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	99.4% 179/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	100.0% 59/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	100.0% 70/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Leukopenia	78.1% 171/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	77.5% 172/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	84.4% 152/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	94.9% 56/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	98.6% 69/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Neutropenia	61.2% 134/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	61.7% 137/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	64.4% 116/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	83.1% 49/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	81.4% 57/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Thrombocytopenia	74.9% 164/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	82.4% 183/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	93.3% 168/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	96.6% 57/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	95.7% 67/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Cardiac disorders Edema	15.5% 34/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	20.7% 46/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	9.4% 17/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.8% 4/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	10.0% 7/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Cardiac disorders Hypotension	2.7% 6/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.3% 5/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.3% 6/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.7% 4/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
General disorders Fatigue	35.2% 77/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	35.6% 79/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	43.3% 78/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	30.5% 18/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	37.1% 26/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
General disorders Fever w/o neutropenia	3.7% 8/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.3% 14/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.7% 12/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.8% 4/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
General disorders Rigors/Chills	13.2% 29/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	14.0% 31/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	12.2% 22/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	10.2% 6/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	20.0% 14/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
General disorders Sweating	3.7% 8/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.8% 15/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.2% 4/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	4.3% 3/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
General disorders Weight Loss	6.8% 15/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	4.1% 9/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.6% 10/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.8% 4/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	4.3% 3/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Skin and subcutaneous tissue disorders Alopecia	28.8% 63/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	31.5% 70/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	41.1% 74/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	42.4% 25/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	37.1% 26/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Skin and subcutaneous tissue disorders Flushing	1.8% 4/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.90% 2/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.8% 5/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	8.5% 5/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Skin and subcutaneous tissue disorders Pruritis/Itching	5.5% 12/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.0% 11/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.8% 5/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Skin and subcutaneous tissue disorders Rash/Desquamation	21.9% 48/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	19.4% 43/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	17.2% 31/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	20.3% 12/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	12.9% 9/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Anorexia	23.7% 52/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	18.5% 41/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	16.1% 29/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	23.7% 14/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	15.7% 11/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Constipation	11.4% 25/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	9.9% 22/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.1% 11/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	11.9% 7/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	11.4% 8/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Heartburn/Dyspepsia	6.8% 15/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.9% 13/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.2% 4/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.4% 2/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Dysphagia	7.8% 17/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	4.5% 10/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.8% 5/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.9% 2/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Nausea	40.6% 89/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	39.6% 88/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	22.8% 41/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	28.8% 17/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	34.3% 24/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Stomatitis	31.1% 68/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	27.5% 61/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	16.1% 29/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	23.7% 14/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	12.9% 9/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Taste Disturbance	9.6% 21/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	7.2% 16/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.9% 7/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.8% 4/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.9% 2/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Vomiting	25.6% 56/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	17.6% 39/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	8.9% 16/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	15.3% 9/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	11.4% 8/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Diarrhea w/o Prior Colostomy	48.9% 107/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	41.4% 92/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	20.6% 37/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	33.9% 20/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	24.3% 17/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Epistaxis	5.9% 13/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	8.1% 18/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.3% 6/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.8% 4/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Blood and lymphatic system disorders Petechiae	9.6% 21/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	7.2% 16/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.6% 10/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.8% 4/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	2.9% 2/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Alkaline Phosphatase Increased	46.1% 101/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	42.8% 95/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	31.7% 57/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	28.8% 17/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	21.4% 15/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Bilirubin Increased	53.4% 117/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	50.9% 113/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	33.9% 61/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	20.3% 12/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	20.0% 14/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Hypoalbuminemia	5.9% 13/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.0% 11/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.3% 6/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.8% 4/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	4.3% 3/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations AST, SGOT Increased	44.3% 97/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	37.8% 84/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	23.3% 42/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	32.2% 19/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	10.0% 7/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations ALT, SGPT Increased	34.2% 75/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	41.4% 92/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	26.1% 47/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	33.9% 20/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	17.1% 12/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Hyperglycemia	8.2% 18/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.0% 11/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.1% 11/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	10.2% 6/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.7% 4/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Hypermagnesemia	16.0% 35/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	9.9% 22/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	7.8% 14/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.8% 4/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	4.3% 3/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Hypocalcemia	10.5% 23/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	7.7% 17/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.0% 9/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	8.5% 5/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	4.3% 3/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Hypomagnesemia	42.0% 92/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	36.9% 82/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	31.1% 56/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	47.5% 28/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	31.4% 22/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Hyponatremia	9.1% 20/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	7.2% 16/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.3% 6/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.1% 3/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Ataxia	5.0% 11/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.8% 4/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.3% 6/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.4% 2/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Confusion	7.8% 17/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.6% 8/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.56% 1/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 1/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Dizziness/Lightheadedness	8.7% 19/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.6% 8/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.7% 12/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 1/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.7% 4/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Tremor	13.2% 29/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.4% 12/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.7% 3/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	8.5% 5/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	4.3% 3/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Gastrointestinal disorders Pain, Abdomen	12.8% 28/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	7.7% 17/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.6% 10/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.8% 4/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	7.1% 5/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Musculoskeletal and connective tissue disorders Pain, Joint (Arthralgia)	4.1% 9/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.45% 1/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.9% 7/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	8.6% 6/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Musculoskeletal and connective tissue disorders Pain, Bone	3.2% 7/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	1.4% 3/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	4.4% 8/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	0.00% 0/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.7% 4/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Nervous system disorders Pain, Headache	10.0% 22/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	13.5% 30/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	7.8% 14/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.1% 3/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	11.4% 8/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Musculoskeletal and connective tissue disorders Pain, Muscle (Myalgia)	4.6% 10/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	4.1% 9/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	6.1% 11/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.4% 2/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	8.6% 6/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Respiratory, thoracic and mediastinal disorders Cough	7.3% 16/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	8.6% 19/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.3% 6/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.4% 2/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	7.1% 5/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.2% 18/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	5.9% 13/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.9% 7/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	3.4% 2/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	8.6% 6/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.
Investigations Creatinine Increased	35.6% 78/219 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	26.6% 59/222 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	12.8% 23/180 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	16.9% 10/59 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.	10.0% 7/70 • Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months. In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.

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