S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML

A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) During Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg®) or No Additional Therapy For Patients Under Age 61 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00085709

Enrollment

637

Registered

2004-06-16

Start date

2004-07-31

Completion date

2014-08-31

Last updated

2015-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

untreated adult acute myeloid leukemia, adult acute eosinophilic leukemia, adult acute basophilic leukemia, adult acute monocytic leukemia (M5b), adult acute erythroid leukemia (M6), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22)

Brief summary

RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop cancer cells from dividing so they stop growing and die. Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with gemtuzumab ozogamicin may kill more cancer cells. It is not yet known whether induction therapy using cytarabine and daunorubicin is more effective with or without gemtuzumab ozogamicin or whether postconsolidation therapy using gemtuzumab ozogamicin is more effective than no additional therapy in treating de novo (first occurrence) acute myeloid leukemia. PURPOSE: This randomized phase III trial is comparing two different regimens of chemotherapy and monoclonal antibody therapy to see how well they work in treating patients with previously untreated de novo acute myeloid leukemia.

Detailed description

OBJECTIVES: * Compare disease-free survival of patients with previously untreated de novo acute myeloid leukemia treated with induction therapy comprising cytarabine and daunorubicin with vs without gemtuzumab ozogamicin followed by consolidation therapy comprising high-dose cytarabine and post-consolidation therapy comprising gemtuzumab ozogamicin vs no additional therapy. * Compare the complete remission rate in patients treated with these regimens. * Compare the frequency and severity of the toxic effects of these regimens in these patients. Other objectives (if funding allows): * Determine the prognostic significance of CD33 expression on the response rate in patients receiving gemtuzumab ozogamicin. * Determine the prognostic significance of FLT3 mutations in these patients before treatment with these regimens. * Determine the prognostic significance of minimal residual disease in remission specimens from these patients treated with these regimens. * Determine the prognostic significance of the flow cytometric detection of minimal residual disease in specimens collected from these patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified during induction therapy according to age (\< 35 years vs ≥ 35 years) and during post-consolidation therapy according to preinduction cytogenetic risk group. * Induction therapy: Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive daunorubicin IV on days 1-3, cytarabine IV continuously on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 4. Patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) IV or subcutaneously once daily beginning on day 15 and continuing until blood counts recover. * Arm II: Patients receive daunorubicin, cytarabine, and G-CSF or GM-CSF as in arm I. Patients in both arms undergo bone marrow aspiration and biopsy on day 14 (and on day 19, if applicable) and then proceed to reinduction therapy. * Reinduction therapy: Patients receive daunorubicin IV on days 1-3 and cytarabine IV continuously on days 1-7. Patients also receive G-CSF or GM-CSF as in induction therapy. Patients who achieve A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status proceed to consolidation therapy. * Consolidation therapy: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1, 3, and 5. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who maintain A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status after consolidation therapy proceed to post-consolidation therapy. * Post-consolidation therapy: Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive no additional therapy. Patients are observed at days 30 and 60 after randomization. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years. PROJECTED ACCRUAL: A total of 684 patients (342 per treatment arm) will be accrued for this study within 4.5-5 years.

Interventions

DRUGgemtuzumab ozogamicin

Given IV, induction Arm1 6mg/m2 D4; post-consolidation 5mg/m2 3 doses \>/= 28 days apart

OTHERobservation

No treatment given

DRUGCytosine arabinoside

IV; induction Arms1/2 and reinduction 100 mg/m2/d days 1-7; consolidation 3gm/m2 q3hrs D1, 3, 5

DRUGDaunomycin

IV; induction Arm1 45mg/m2 D1-3; Arm2 and reinduction 60 mg/m2 D1-3;

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspiration and biopsy\* within the past 14 days * No M3 disease NOTE: \*Patients with marked leukocytosis may be registered before the availability of biopsy results if the absolute blast count is ≥ 100,000 cells/µL * No blastic transformation of chronic myelogenous leukemia * No pre-existing hematologic disorder evolving to AML (e.g., myelodysplasia or secondary leukemia) PATIENT CHARACTERISTICS: Age * 18 to 60 Performance status * Zubrod 0-3 Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Bilirubin ≤ 2 times upper limit of normal (ULN) * AST and ALT ≤ 3 times ULN * No known hepatitis B or C infection * No known liver disease Renal * Not specified Cardiovascular * LVEF ≥ 50% by MUGA or echocardiogram * No unstable cardiac arrhythmias * No unstable angina Other * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior systemic chemotherapy * Prior hydroxyurea to control high cell counts allowed * No more than 1 prior dose of intrathecal chemotherapy for acute leukemia * Concurrent intrathecal chemotherapy allowed during induction therapy Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

Design outcomes

Primary

Measure	Time frame	Description
2-year Disease-free Survival (DFS)	After completing any treatment, every 6 months for 2 years, than annually for years 3-5	Measured from data of randomization to post-consolidation therapy until relapse from complete response or death from any cause, with observations censored at the date of last contact for patients last known to be alive without report of relapse.
Complete Remission	After induction therapy was completed (1 or 2 months)	—

Secondary

Measure	Time frame	Description
Toxicity	For induction, daily for the first 10 days, then twice weekly until consolidation treatment. Weekly during consolidation treatment. Weekly if randomized to post-consolidation G.O.	Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event

Countries

Canada, Sweden, United States

Participant flow

Participants by arm

Arm	Count
Ara-C+Daunomycin+Mylotarg Ara-C+Daunomycin+Mylotarg	296
ARA-C+Daunomycin ARA-C+Daunomycin	300
Total	596

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	8	0
Overall Study	Death	8	2
Overall Study	Not eligible	19	19
Overall Study	Not protocol specified	12	22
Overall Study	Progression	3	4
Overall Study	Refusal unrelated to adverse events	1	2
Overall Study	Withdrawal by Subject	2	1

Baseline characteristics

Characteristic	Ara-C+Daunomycin+Mylotarg	ARA-C+Daunomycin	Total
Age, Continuous	47 years	48 years	47 years
Sex: Female, Male Female	135 Participants	148 Participants	283 Participants
Sex: Female, Male Male	161 Participants	152 Participants	313 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	277 / 293	279 / 293	356 / 375	77 / 78
serious Total, serious adverse events	47 / 293	9 / 293	13 / 375	19 / 78

Outcome results

Primary

2-year Disease-free Survival (DFS)

Measured from data of randomization to post-consolidation therapy until relapse from complete response or death from any cause, with observations censored at the date of last contact for patients last known to be alive without report of relapse.

Time frame: After completing any treatment, every 6 months for 2 years, than annually for years 3-5

Population: Eligible patients who completed induction and consolidation therapy

Arm	Measure	Value (NUMBER)
Post-consolidation GO	2-year Disease-free Survival (DFS)	39 Percentage of population
Post-consolidation Observation	2-year Disease-free Survival (DFS)	50 Percentage of population

Comparison: Interim futility analysis of the alternative hypothesis for disease-free survival. The design specified a hazard ratio of (observation: GO) of 1.5.p-value: <0.001Regression, Cox

Primary

Complete Remission

Time frame: After induction therapy was completed (1 or 2 months)

Population: Eligible patients who did not withdraw consent

Arm	Measure	Value (NUMBER)
Post-consolidation GO	Complete Remission	203 participants
Post-consolidation Observation	Complete Remission	207 participants

Comparison: Interim futility analysis alternative hypothesis based on the design specification that the 7+3+GO arm would have a 12% increase in CR rate.p-value: <0.0025Test of difference of proportions

Secondary

Toxicity

Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event

Time frame: For induction, daily for the first 10 days, then twice weekly until consolidation treatment. Weekly during consolidation treatment. Weekly if randomized to post-consolidation G.O.

Population: Eligible patients who started therapy

Arm	Measure	Group	Value (NUMBER)
Post-consolidation GO	Toxicity	Acidosis (metabolic or respiratory)	2 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with norm ANC or Grade 1/2 neut - Colon	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with norm ANC or Gr 1/2 neut, Catheter-rel	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hemolysis	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Potassium, serum-low (hypokalemia)	21 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with normal ANC or Grade 1/2 neut - Blood	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Wound	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hemorrhage, CNS	5 Participants with a given type of AE
Post-consolidation GO	Toxicity	Potassium, serum-high (hyperkalemia)	4 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Vulva	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infection with Grade 3 or 4 neut - Urinary tract	6 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hemorrhage, GI - Abdomen NOS	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Bilirubin (hyperbilirubinemia)	14 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Upper airway	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Small bowel N	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hemorrhage, GI - Jejunum	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Vision-blurred vision	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Skin (celluli	4 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Sinus	2 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hemorrhage, GI - Lower GI NOS	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Portal vein flow	2 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Rectum	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut- Pharynx	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hemorrhage, GI - Oral cavity	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pneumonitis/pulmonary infiltrates	3 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Pelvis NOS	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Oral cavity-g	2 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hemorrhage, GI - Rectum	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Blood/Bone Marrow-Other (Specify)	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Nerve-periphe	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infect with Grade 3 or 4 neut - Mucosa	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Meninges (men	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hemorrhage, GU - Kidney	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Tumor lysis syndrome	2 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Lung (pneumon	22 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Liver	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hemorrhage, GU - Urinary NOS	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pleural effusion (non-malignant)	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Lip/perioral	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Heart (endoca	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hemorrhage, GU - Uterus	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Platelets	145 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Dental-tooth	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Colon	5 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hemorrhage, GU - Vagina	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Bronchospasm, wheezing	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Cecum	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Catheter-rela	5 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hemorrhage, pulmonary/upper respiratory - Lung	5 Participants with a given type of AE
Post-consolidation GO	Toxicity	Thrombotic microangiopathy	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Bronchus	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Brain + Spina	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hemorrhage, pulmonary/upper respiratory - Nose	3 Participants with a given type of AE
Post-consolidation GO	Toxicity	Phosphate, serum-low (hypophosphatemia)	10 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Bone (osteomy	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Blood	30 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hemorrhage/Bleeding-Other (Specify)	8 Participants with a given type of AE
Post-consolidation GO	Toxicity	Petechiae/purpura	6 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Bladder (urin	2 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Appendix	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hepatobiliary/Pancreas-Other (Specify)	3 Participants with a given type of AE
Post-consolidation GO	Toxicity	Calcium, serum-low (hypocalcemia)	13 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Anal/perianal	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with Grade 3 or 4 neut - Abdomen NOS	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hiccoughs (hiccups, singultus)	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Adult respiratory distress syndrome (ARDS)	7 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hypoxia	8 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hypotension	5 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hypertension	2 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pericarditis	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pericardial effusion (non-malignant)	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Cardiac Arrhythmia-Other (Specify)	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hemorrhage, GU - Bladder	2 Participants with a given type of AE
Post-consolidation GO	Toxicity	Perforation, GI - Colon	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pancreatic endocrine: glucose intolerance	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Cardiac General-Other (Specify)	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Thrombosis/thrombus/embolism	4 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pain-Other (Specify)	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pain - Throat/pharynx/larynx	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Cardiac troponin I (cTnI)	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Albumin, serum-low (hypoalbuminemia)	15 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pain - Rectum	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pain - Oral-gums	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Cardiac troponin T (cTnT)	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	ALT, SGPT (serum glutamic pyruvic transaminase)	29 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pain - Muscle	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pain - Joint	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Cardiac-ischemia/infarction	2 Participants with a given type of AE
Post-consolidation GO	Toxicity	Thrombosis/embolism (vascular access-related)	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pain - Head/headache	8 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pain - Eye	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Colitis	2 Participants with a given type of AE
Post-consolidation GO	Toxicity	Syndromes-Other (Specify)	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pain - Extremity-limb	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pain - Chest/thorax NOS	2 Participants with a given type of AE
Post-consolidation GO	Toxicity	Colitis, infectious (e.g., Clostridium difficile)	8 Participants with a given type of AE
Post-consolidation GO	Toxicity	Alkaline phosphatase	3 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pain - Bone	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pain - Back	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Confusion	3 Participants with a given type of AE
Post-consolidation GO	Toxicity	Vomiting	2 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pain - Anus	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pain - Abdomen NOS	8 Participants with a given type of AE
Post-consolidation GO	Toxicity	Constipation	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Syncope (fainting)	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	PTT (Partial thromboplastin time)	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Opportunistic infec assoc with Gr 2 lymphopenia	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Cough	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Supraventricular arrhythmia NOS	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Ocular/Visual-Other (Specify)	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Obstruction/stenosis of airway - Trachea	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Creatinine	3 Participants with a given type of AE
Post-consolidation GO	Toxicity	Alkalosis (metabolic or respiratory)	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Nystagmus	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Neutrophils/granulocytes (ANC/AGC)	111 Participants with a given type of AE
Post-consolidation GO	Toxicity	DIC (disseminated intravascular coagulation)	2 Participants with a given type of AE
Post-consolidation GO	Toxicity	Ventricular arrhythmia - Ventricular fibrillation	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Neuropathy: sensory	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Neuropathy: motor	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Death not assoc with CTCAE term-Multi-organ failu	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Sinus tachycardia	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Neurology-Other (Specify)	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Necrosis, GI - Rectum	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Dehydration	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Atrial fibrillation	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Nausea	7 Participants with a given type of AE
Post-consolidation GO	Toxicity	Nasal cavity/paranasal sinus reactions	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Diarrhea	5 Participants with a given type of AE
Post-consolidation GO	Toxicity	Allergic reaction/hypersens. (inc drug fever)	6 Participants with a given type of AE
Post-consolidation GO	Toxicity	Muscle weakness (func/sym, Whole body/generalized	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Mucositis/stomatitis (func/sympt) - Pharynx	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Distention/bloating, abdominal	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Vasovagal episode	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Mucositis/stomatitis (func/sympt)- Oral cavity	4 Participants with a given type of AE
Post-consolidation GO	Toxicity	Mucositis/stomatitis (func/sympt) - Esophagus	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Dizziness	2 Participants with a given type of AE
Post-consolidation GO	Toxicity	Somnolence/depressed level of consciousness	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Mucositis/stomatitis (clinical exam) - Pharynx	2 Participants with a given type of AE
Post-consolidation GO	Toxicity	Mucositis/stomatitis (clinical exam) - Oral cavity	6 Participants with a given type of AE
Post-consolidation GO	Toxicity	Dysphagia (difficulty swallowing)	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Sodium, serum-low (hyponatremia)	8 Participants with a given type of AE
Post-consolidation GO	Toxicity	Mucositis/stomatitis (clinical exam) - Larynx	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Mucositis/stomatitis (clinical exam) - Large bowel	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Dyspnea (shortness of breath)	10 Participants with a given type of AE
Post-consolidation GO	Toxicity	Amylase	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Mucositis/stomatitis (clinical exam) - Esophagus	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Mood alteration - depression	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Edema, larynx	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	AST, SGOT (serum glut. oxaloacetic transaminase)	32 Participants with a given type of AE
Post-consolidation GO	Toxicity	Mood alteration - anxiety	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Metabolic/Laboratory-Other (Specify)	3 Participants with a given type of AE
Post-consolidation GO	Toxicity	Edema: limb	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Sodium, serum-high (hypernatremia)	2 Participants with a given type of AE
Post-consolidation GO	Toxicity	Magnesium, serum-low (hypomagnesemia)	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Lymphopenia	21 Participants with a given type of AE
Post-consolidation GO	Toxicity	Edema: viscera	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Serum sickness	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Liver dysfunction/failure (clinical)	4 Participants with a given type of AE
Post-consolidation GO	Toxicity	Leukoencephalopathy (radiolographic findings)	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Enteritis (inflammation of the small bowel)	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Anorexia	14 Participants with a given type of AE
Post-consolidation GO	Toxicity	Leukocytes (total WBC)	106 Participants with a given type of AE
Post-consolidation GO	Toxicity	Left ventricular systolic dysfunction	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Esophagitis	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Ataxia (incoordination)	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Left ventricular diastolic dysfunction	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infection-Other (Specify)	4 Participants with a given type of AE
Post-consolidation GO	Toxicity	Fatigue (asthenia, lethargy, malaise)	24 Participants with a given type of AE
Post-consolidation GO	Toxicity	Seroma	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infection with unknown ANC - Wound	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infection with unknown ANC - Urinary tract NOS	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Febrile neutropenia	178 Participants with a given type of AE
Post-consolidation GO	Toxicity	Rigors/chills	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infection with unknown ANC - Skin (cellulitis)	4 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infection with unknown ANC - Sinus	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Fever (in the absence of neutropenia)	6 Participants with a given type of AE
Post-consolidation GO	Toxicity	Apnea	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infection with unknown ANC - Mucosa	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infection with unknown ANC - Lung (pneumonia)	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Fistula, GI - Rectum	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Uric acid, serum-high (hyperuricemia)	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infection with unknown ANC - Liver	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infection with unknown ANC - Joint	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Fistula, GU - Vagina	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Renal failure	8 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infection with unknown ANC - Dental-tooth	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infection with unknown ANC - Catheter-related	3 Participants with a given type of AE
Post-consolidation GO	Toxicity	Flu-like syndrome	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Rash/desquamation	6 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infection with unknown ANC - Blood	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with norm ANC or Gr 1/2 neut-Urinary tract	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	GGT (gamma-glutamyl transpeptidase)	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Typhlitis (cecal inflammation)	3 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with norm ANC or Gr 1/2 neut-Skin	2 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with norm ANC or Gr 1/2 neut - Scrotum	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Glucose, serum-high (hyperglycemia)	22 Participants with a given type of AE
Post-consolidation GO	Toxicity	Pulmonary/Upper Respiratory-Other (Specify)	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Inf with norm ANC or Gr 1/2 neut-Oral cavity-gums	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with norm ANC or Gr 1/2 neut - Muscle	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Glucose, serum-low (hypoglycemia)	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Proctitis	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with norm ANC or Gr 1/2 neut-Lung (pneumoni)	6 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with norm ANC or Gr 1/2 neutrophils - Liver	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hematoma	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Bicarbonate, serum-low	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with norm ANC or Gr 1/2 neut - Heart	0 Participants with a given type of AE
Post-consolidation GO	Toxicity	Infec with norm ANC or Gr 1/2 neutr- Dental-tooth	1 Participants with a given type of AE
Post-consolidation GO	Toxicity	Hemoglobin	101 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hemoglobin	87 Participants with a given type of AE
Post-consolidation Observation	Toxicity	ALT, SGPT (serum glutamic pyruvic transaminase)	11 Participants with a given type of AE
Post-consolidation Observation	Toxicity	AST, SGOT (serum glut. oxaloacetic transaminase)	11 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Acidosis (metabolic or respiratory)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Adult respiratory distress syndrome (ARDS)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Albumin, serum-low (hypoalbuminemia)	10 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Alkaline phosphatase	2 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Alkalosis (metabolic or respiratory)	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Allergic reaction/hypersens. (inc drug fever)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Amylase	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Anorexia	13 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Apnea	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Ataxia (incoordination)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Bicarbonate, serum-low	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Bilirubin (hyperbilirubinemia)	11 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Blood/Bone Marrow-Other (Specify)	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Bronchospasm, wheezing	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Calcium, serum-low (hypocalcemia)	7 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Cardiac Arrhythmia-Other (Specify)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Cardiac General-Other (Specify)	2 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Cardiac troponin I (cTnI)	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Cardiac troponin T (cTnT)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Cardiac-ischemia/infarction	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Colitis	6 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Colitis, infectious (e.g., Clostridium difficile)	10 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Confusion	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Constipation	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Cough	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Creatinine	2 Participants with a given type of AE
Post-consolidation Observation	Toxicity	DIC (disseminated intravascular coagulation)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Death not assoc with CTCAE term-Multi-organ failu	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Dehydration	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Diarrhea	19 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Distention/bloating, abdominal	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Dizziness	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Dysphagia (difficulty swallowing)	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Dyspnea (shortness of breath)	6 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Edema, larynx	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Edema: limb	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Edema: viscera	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Enteritis (inflammation of the small bowel)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Esophagitis	3 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Fatigue (asthenia, lethargy, malaise)	25 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Febrile neutropenia	196 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Fever (in the absence of neutropenia)	8 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Fistula, GI - Rectum	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Fistula, GU - Vagina	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Flu-like syndrome	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	GGT (gamma-glutamyl transpeptidase)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Glucose, serum-high (hyperglycemia)	12 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Glucose, serum-low (hypoglycemia)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hematoma	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hemorrhage, GU - Bladder	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hemolysis	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hemorrhage, CNS	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hemorrhage, GI - Abdomen NOS	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hemorrhage, GI - Jejunum	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hemorrhage, GI - Lower GI NOS	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hemorrhage, GI - Oral cavity	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hemorrhage, GI - Rectum	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hemorrhage, GU - Kidney	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hemorrhage, GU - Urinary NOS	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hemorrhage, GU - Uterus	2 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hemorrhage, GU - Vagina	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hemorrhage, pulmonary/upper respiratory - Lung	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hemorrhage, pulmonary/upper respiratory - Nose	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hemorrhage/Bleeding-Other (Specify)	5 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hepatobiliary/Pancreas-Other (Specify)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hiccoughs (hiccups, singultus)	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hypertension	3 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hypotension	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Hypoxia	2 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Abdomen NOS	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Anal/perianal	2 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Appendix	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Bladder (urin	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Blood	25 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Bone (osteomy	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Brain + Spina	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Bronchus	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Catheter-rela	6 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Cecum	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Colon	2 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Dental-tooth	2 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Heart (endoca	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Lip/perioral	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Liver	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Lung (pneumon	27 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Meninges (men	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infect with Grade 3 or 4 neut - Mucosa	2 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Nerve-periphe	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Oral cavity-g	3 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Pelvis NOS	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut- Pharynx	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Rectum	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Sinus	3 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Skin (celluli	3 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Small bowel N	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Upper airway	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infection with Grade 3 or 4 neut - Urinary tract	6 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Vulva	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with Grade 3 or 4 neut - Wound	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with normal ANC or Grade 1/2 neut - Blood	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with norm ANC or Gr 1/2 neut, Catheter-rel	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with norm ANC or Grade 1/2 neut - Colon	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with norm ANC or Gr 1/2 neutr- Dental-tooth	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with norm ANC or Gr 1/2 neut - Heart	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with norm ANC or Gr 1/2 neutrophils - Liver	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with norm ANC or Gr 1/2 neut-Lung (pneumoni)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with norm ANC or Gr 1/2 neut - Muscle	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Inf with norm ANC or Gr 1/2 neut-Oral cavity-gums	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with norm ANC or Gr 1/2 neut - Scrotum	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with norm ANC or Gr 1/2 neut-Skin	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infec with norm ANC or Gr 1/2 neut-Urinary tract	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infection with unknown ANC - Blood	3 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infection with unknown ANC - Catheter-related	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infection with unknown ANC - Dental-tooth	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infection with unknown ANC - Joint	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infection with unknown ANC - Liver	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infection with unknown ANC - Lung (pneumonia)	2 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infection with unknown ANC - Mucosa	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infection with unknown ANC - Sinus	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infection with unknown ANC - Skin (cellulitis)	3 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infection with unknown ANC - Urinary tract NOS	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infection with unknown ANC - Wound	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Infection-Other (Specify)	4 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Left ventricular diastolic dysfunction	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Left ventricular systolic dysfunction	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Leukocytes (total WBC)	96 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Leukoencephalopathy (radiolographic findings)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Liver dysfunction/failure (clinical)	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Lymphopenia	23 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Magnesium, serum-low (hypomagnesemia)	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Metabolic/Laboratory-Other (Specify)	5 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Mood alteration - anxiety	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Mood alteration - depression	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Mucositis/stomatitis (clinical exam) - Esophagus	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Mucositis/stomatitis (clinical exam) - Large bowel	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Mucositis/stomatitis (clinical exam) - Larynx	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Mucositis/stomatitis (clinical exam) - Oral cavity	11 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Mucositis/stomatitis (clinical exam) - Pharynx	2 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Mucositis/stomatitis (func/sympt) - Esophagus	2 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Mucositis/stomatitis (func/sympt)- Oral cavity	9 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Mucositis/stomatitis (func/sympt) - Pharynx	2 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Muscle weakness (func/sym, Whole body/generalized	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Nasal cavity/paranasal sinus reactions	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Nausea	13 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Necrosis, GI - Rectum	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Neurology-Other (Specify)	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Neuropathy: motor	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Neuropathy: sensory	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Neutrophils/granulocytes (ANC/AGC)	110 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Nystagmus	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Obstruction/stenosis of airway - Trachea	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Ocular/Visual-Other (Specify)	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Opportunistic infec assoc with Gr 2 lymphopenia	2 Participants with a given type of AE
Post-consolidation Observation	Toxicity	PTT (Partial thromboplastin time)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pain - Abdomen NOS	5 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pain - Anus	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pain - Back	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pain - Bone	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pain - Chest/thorax NOS	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pain - Extremity-limb	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pain - Eye	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pain - Head/headache	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pain - Joint	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pain - Muscle	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pain - Oral-gums	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pain - Rectum	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pain - Throat/pharynx/larynx	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pain-Other (Specify)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pancreatic endocrine: glucose intolerance	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Perforation, GI - Colon	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pericardial effusion (non-malignant)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pericarditis	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Petechiae/purpura	2 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Phosphate, serum-low (hypophosphatemia)	9 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Platelets	130 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pleural effusion (non-malignant)	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pneumonitis/pulmonary infiltrates	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Portal vein flow	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Potassium, serum-high (hyperkalemia)	2 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Potassium, serum-low (hypokalemia)	15 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Proctitis	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Pulmonary/Upper Respiratory-Other (Specify)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Rash/desquamation	9 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Renal failure	6 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Rigors/chills	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Seroma	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Serum sickness	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Sodium, serum-high (hypernatremia)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Sodium, serum-low (hyponatremia)	15 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Somnolence/depressed level of consciousness	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Atrial fibrillation	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Sinus tachycardia	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Supraventricular arrhythmia NOS	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Syncope (fainting)	3 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Syndromes-Other (Specify)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Thrombosis/embolism (vascular access-related)	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Thrombosis/thrombus/embolism	4 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Thrombotic microangiopathy	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Tumor lysis syndrome	2 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Typhlitis (cecal inflammation)	4 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Uric acid, serum-high (hyperuricemia)	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Vasovagal episode	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Ventricular arrhythmia - Ventricular fibrillation	0 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Vision-blurred vision	1 Participants with a given type of AE
Post-consolidation Observation	Toxicity	Vomiting	5 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Constipation	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Edema: viscera	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	PTT (Partial thromboplastin time)	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Seroma	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Liver dysfunction/failure (clinical)	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with norm ANC or Gr 1/2 neutr- Dental-tooth	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pain - Abdomen NOS	3 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Vision-blurred vision	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Confusion	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Supraventricular arrhythmia NOS	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pain - Anus	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infection with unknown ANC - Joint	2 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Lymphopenia	50 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with norm ANC or Gr 1/2 neutrophils - Liver	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pain - Back	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Edema: limb	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Colitis, infectious (e.g., Clostridium difficile)	4 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Alkaline phosphatase	2 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pain - Bone	4 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Fistula, GI - Rectum	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Magnesium, serum-low (hypomagnesemia)	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	ALT, SGPT (serum glutamic pyruvic transaminase)	22 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pain - Chest/thorax NOS	2 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Rash/desquamation	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Colitis	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Syncope (fainting)	4 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pain - Extremity-limb	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infection with unknown ANC - Liver	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Bicarbonate, serum-low	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Metabolic/Laboratory-Other (Specify)	4 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pain - Eye	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with norm ANC or Gr 1/2 neut - Scrotum	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Cardiac-ischemia/infarction	4 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Edema, larynx	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pain - Head/headache	8 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Serum sickness	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Mood alteration - anxiety	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Glucose, serum-low (hypoglycemia)	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pain - Joint	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infection with unknown ANC - Lung (pneumonia)	2 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Cardiac troponin T (cTnT)	3 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Syndromes-Other (Specify)	2 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pain - Muscle	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	GGT (gamma-glutamyl transpeptidase)	4 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Mood alteration - depression	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Fever (in the absence of neutropenia)	16 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pain - Oral-gums	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Dyspnea (shortness of breath)	10 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Cardiac troponin I (cTnI)	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Albumin, serum-low (hypoalbuminemia)	3 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pain - Rectum	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Amylase	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Mucositis/stomatitis (clinical exam) - Esophagus	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Ventricular arrhythmia - Ventricular fibrillation	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pain - Throat/pharynx/larynx	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Apnea	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Cardiac General-Other (Specify)	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Thrombosis/embolism (vascular access-related)	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pain-Other (Specify)	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infection with unknown ANC - Mucosa	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Uric acid, serum-high (hyperuricemia)	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Mucositis/stomatitis (clinical exam) - Large bowel	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pancreatic endocrine: glucose intolerance	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Ataxia (incoordination)	2 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Cardiac Arrhythmia-Other (Specify)	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Dysphagia (difficulty swallowing)	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Perforation, GI - Colon	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Sodium, serum-high (hypernatremia)	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Mucositis/stomatitis (clinical exam) - Larynx	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with norm ANC or Gr 1/2 neut-Skin	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hypertension	2 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Typhlitis (cecal inflammation)	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infection with unknown ANC - Sinus	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pericardial effusion (non-malignant)	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hypotension	4 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Mucositis/stomatitis (clinical exam) - Oral cavity	2 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hiccoughs (hiccups, singultus)	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hematoma	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hypoxia	6 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Dizziness	3 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Febrile neutropenia	183 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Calcium, serum-low (hypocalcemia)	3 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Abdomen NOS	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Mucositis/stomatitis (clinical exam) - Pharynx	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hepatobiliary/Pancreas-Other (Specify)	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Thrombosis/thrombus/embolism	4 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Anal/perianal	4 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Renal failure	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infection with unknown ANC - Skin (cellulitis)	3 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pericarditis	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Appendix	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with norm ANC or Gr 1/2 neut-Lung (pneumoni)	9 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hemorrhage/Bleeding-Other (Specify)	12 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Mucositis/stomatitis (func/sympt) - Esophagus	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Bladder (urin	4 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Potassium, serum-low (hypokalemia)	19 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Distention/bloating, abdominal	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Sodium, serum-low (hyponatremia)	4 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Blood	47 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Mucositis/stomatitis (func/sympt)- Oral cavity	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hemorrhage, pulmonary/upper respiratory - Nose	4 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with norm ANC or Gr 1/2 neut-Urinary tract	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Bone (osteomy	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infection with unknown ANC - Urinary tract NOS	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with norm ANC or Gr 1/2 neut - Heart	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Petechiae/purpura	3 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Brain + Spina	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Mucositis/stomatitis (func/sympt) - Pharynx	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hemorrhage, pulmonary/upper respiratory - Lung	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Fatigue (asthenia, lethargy, malaise)	22 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Bronchus	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Diarrhea	4 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Allergic reaction/hypersens. (inc drug fever)	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Bronchospasm, wheezing	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Catheter-rela	13 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Muscle weakness (func/sym, Whole body/generalized	2 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hemorrhage, GU - Vagina	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Flu-like syndrome	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Cecum	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infection with unknown ANC - Wound	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pulmonary/Upper Respiratory-Other (Specify)	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Phosphate, serum-low (hypophosphatemia)	6 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Colon	2 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Nasal cavity/paranasal sinus reactions	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hemorrhage, GU - Uterus	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infection with unknown ANC - Blood	7 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Dental-tooth	3 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Dehydration	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Somnolence/depressed level of consciousness	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Nausea	7 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Heart (endoca	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with norm ANC or Grade 1/2 neut - Colon	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hemorrhage, GU - Urinary NOS	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infection-Other (Specify)	4 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Lip/perioral	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with norm ANC or Gr 1/2 neut - Muscle	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Necrosis, GI - Rectum	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Platelets	226 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Liver	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Esophagitis	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hemorrhage, GU - Kidney	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Death not assoc with CTCAE term-Multi-organ failu	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Lung (pneumon	22 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Rigors/chills	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Neurology-Other (Specify)	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Blood/Bone Marrow-Other (Specify)	2 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Meninges (men	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Left ventricular diastolic dysfunction	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hemorrhage, GU - Bladder	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Thrombotic microangiopathy	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infect with Grade 3 or 4 neut - Mucosa	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Tumor lysis syndrome	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hemorrhage, GI - Rectum	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pleural effusion (non-malignant)	3 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Nerve-periphe	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Adult respiratory distress syndrome (ARDS)	2 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Neuropathy: motor	2 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infection with unknown ANC - Catheter-related	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Oral cavity-g	2 Participants with a given type of AE
Ara-C Consolidation	Toxicity	DIC (disseminated intravascular coagulation)	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hemorrhage, GI - Oral cavity	2 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Atrial fibrillation	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Pelvis NOS	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Neuropathy: sensory	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Glucose, serum-high (hyperglycemia)	15 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Left ventricular systolic dysfunction	2 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut- Pharynx	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Fistula, GU - Vagina	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hemorrhage, GI - Lower GI NOS	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Pneumonitis/pulmonary infiltrates	5 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Rectum	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Neutrophils/granulocytes (ANC/AGC)	193 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Enteritis (inflammation of the small bowel)	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Creatinine	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Sinus	2 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Alkalosis (metabolic or respiratory)	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hemorrhage, GI - Jejunum	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Bilirubin (hyperbilirubinemia)	4 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Skin (celluli	9 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Nystagmus	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Anorexia	2 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Acidosis (metabolic or respiratory)	2 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Small bowel N	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Leukocytes (total WBC)	151 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hemorrhage, GI - Abdomen NOS	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Portal vein flow	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Upper airway	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Vasovagal episode	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Obstruction/stenosis of airway - Trachea	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Proctitis	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infection with Grade 3 or 4 neut - Urinary tract	6 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Cough	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hemorrhage, CNS	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Sinus tachycardia	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Vulva	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Ocular/Visual-Other (Specify)	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infection with unknown ANC - Dental-tooth	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Vomiting	5 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with Grade 3 or 4 neut - Wound	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	AST, SGOT (serum glut. oxaloacetic transaminase)	17 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hemolysis	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Potassium, serum-high (hyperkalemia)	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with normal ANC or Grade 1/2 neut - Blood	6 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Leukoencephalopathy (radiolographic findings)	1 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Opportunistic infec assoc with Gr 2 lymphopenia	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Inf with norm ANC or Gr 1/2 neut-Oral cavity-gums	0 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Infec with norm ANC or Gr 1/2 neut, Catheter-rel	4 Participants with a given type of AE
Ara-C Consolidation	Toxicity	Hemoglobin	144 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with norm ANC or Gr 1/2 neut, Catheter-rel	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with norm ANC or Grade 1/2 neut - Colon	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hematoma	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with norm ANC or Gr 1/2 neutr- Dental-tooth	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with norm ANC or Gr 1/2 neut - Heart	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Glucose, serum-low (hypoglycemia)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Potassium, serum-low (hypokalemia)	3 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with norm ANC or Gr 1/2 neutrophils - Liver	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Ataxia (incoordination)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with norm ANC or Gr 1/2 neut-Lung (pneumoni)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Glucose, serum-high (hyperglycemia)	2 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Tumor lysis syndrome	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with norm ANC or Gr 1/2 neut - Muscle	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Inf with norm ANC or Gr 1/2 neut-Oral cavity-gums	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	GGT (gamma-glutamyl transpeptidase)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Proctitis	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with norm ANC or Gr 1/2 neut - Scrotum	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with norm ANC or Gr 1/2 neut-Skin	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Flu-like syndrome	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	AST, SGOT (serum glut. oxaloacetic transaminase)	2 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with norm ANC or Gr 1/2 neut-Urinary tract	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infection with unknown ANC - Blood	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Fistula, GU - Vagina	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pulmonary/Upper Respiratory-Other (Specify)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infection with unknown ANC - Catheter-related	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Apnea	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infection with unknown ANC - Dental-tooth	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Fistula, GI - Rectum	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infection with unknown ANC - Joint	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infection with unknown ANC - Liver	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Fever (in the absence of neutropenia)	1 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Rash/desquamation	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infection with unknown ANC - Lung (pneumonia)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infection with unknown ANC - Mucosa	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Febrile neutropenia	22 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infection with unknown ANC - Sinus	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infection with unknown ANC - Skin (cellulitis)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Fatigue (asthenia, lethargy, malaise)	4 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Renal failure	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infection with unknown ANC - Urinary tract NOS	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Anorexia	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infection with unknown ANC - Wound	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Esophagitis	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Typhlitis (cecal inflammation)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infection-Other (Specify)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Left ventricular diastolic dysfunction	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Enteritis (inflammation of the small bowel)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Rigors/chills	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Left ventricular systolic dysfunction	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Leukocytes (total WBC)	41 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Edema: viscera	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Leukoencephalopathy (radiolographic findings)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Liver dysfunction/failure (clinical)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Edema: limb	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Seroma	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Lymphopenia	4 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Amylase	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Magnesium, serum-low (hypomagnesemia)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Edema, larynx	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Vision-blurred vision	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Metabolic/Laboratory-Other (Specify)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Mood alteration - anxiety	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Dyspnea (shortness of breath)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Serum sickness	1 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Mood alteration - depression	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Mucositis/stomatitis (clinical exam) - Esophagus	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Dysphagia (difficulty swallowing)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Mucositis/stomatitis (clinical exam) - Large bowel	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Mucositis/stomatitis (clinical exam) - Larynx	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Dizziness	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Sodium, serum-high (hypernatremia)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Mucositis/stomatitis (clinical exam) - Oral cavity	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Allergic reaction/hypersens. (inc drug fever)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Mucositis/stomatitis (clinical exam) - Pharynx	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Distention/bloating, abdominal	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Uric acid, serum-high (hyperuricemia)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Mucositis/stomatitis (func/sympt) - Esophagus	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Mucositis/stomatitis (func/sympt)- Oral cavity	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Diarrhea	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Sodium, serum-low (hyponatremia)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Mucositis/stomatitis (func/sympt) - Pharynx	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Muscle weakness (func/sym, Whole body/generalized	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Dehydration	1 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	ALT, SGPT (serum glutamic pyruvic transaminase)	2 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Nasal cavity/paranasal sinus reactions	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Nausea	1 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Death not assoc with CTCAE term-Multi-organ failu	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Somnolence/depressed level of consciousness	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Necrosis, GI - Rectum	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Alkalosis (metabolic or respiratory)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Neurology-Other (Specify)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	DIC (disseminated intravascular coagulation)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Neuropathy: motor	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Neuropathy: sensory	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Creatinine	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Atrial fibrillation	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Neutrophils/granulocytes (ANC/AGC)	43 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Nystagmus	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Cough	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Obstruction/stenosis of airway - Trachea	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Ocular/Visual-Other (Specify)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Constipation	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Sinus tachycardia	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Opportunistic infec assoc with Gr 2 lymphopenia	1 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Alkaline phosphatase	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	PTT (Partial thromboplastin time)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Confusion	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Vasovagal episode	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pain - Abdomen NOS	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pain - Anus	1 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Colitis, infectious (e.g., Clostridium difficile)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Supraventricular arrhythmia NOS	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pain - Back	1 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pain - Bone	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Colitis	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pain - Chest/thorax NOS	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pain - Extremity-limb	1 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Cardiac-ischemia/infarction	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Syncope (fainting)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pain - Eye	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Albumin, serum-low (hypoalbuminemia)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pain - Head/headache	1 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Cardiac troponin T (cTnT)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Vomiting	1 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pain - Joint	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pain - Muscle	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Cardiac troponin I (cTnI)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Syndromes-Other (Specify)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pain - Oral-gums	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pain - Rectum	1 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Cardiac General-Other (Specify)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pain - Throat/pharynx/larynx	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pain-Other (Specify)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Cardiac Arrhythmia-Other (Specify)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Thrombosis/embolism (vascular access-related)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pancreatic endocrine: glucose intolerance	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Adult respiratory distress syndrome (ARDS)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Perforation, GI - Colon	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Calcium, serum-low (hypocalcemia)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Ventricular arrhythmia - Ventricular fibrillation	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hypertension	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hiccoughs (hiccups, singultus)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hypotension	1 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pericardial effusion (non-malignant)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hypoxia	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hepatobiliary/Pancreas-Other (Specify)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Abdomen NOS	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Anal/perianal	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hemorrhage/Bleeding-Other (Specify)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Appendix	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pericarditis	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Bladder (urin	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hemorrhage, pulmonary/upper respiratory - Nose	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Bronchospasm, wheezing	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Blood	4 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Thrombosis/thrombus/embolism	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Bone (osteomy	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hemorrhage, pulmonary/upper respiratory - Lung	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Brain + Spina	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Petechiae/purpura	1 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Bronchus	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hemorrhage, GU - Vagina	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Catheter-rela	2 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Acidosis (metabolic or respiratory)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Cecum	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hemorrhage, GU - Uterus	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Colon	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Phosphate, serum-low (hypophosphatemia)	1 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Dental-tooth	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hemorrhage, GU - Urinary NOS	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Blood/Bone Marrow-Other (Specify)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Heart (endoca	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hemorrhage, GI - Rectum	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Lip/perioral	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hemorrhage, GU - Kidney	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Liver	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Platelets	40 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Lung (pneumon	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hemorrhage, GU - Bladder	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Meninges (men	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infect with Grade 3 or 4 neut - Mucosa	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Nerve-periphe	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hemorrhage, GI - Oral cavity	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pleural effusion (non-malignant)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Oral cavity-g	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Bilirubin (hyperbilirubinemia)	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Pelvis NOS	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hemorrhage, GI - Lower GI NOS	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Thrombotic microangiopathy	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut- Pharynx	1 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Rectum	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hemorrhage, GI - Jejunum	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Pneumonitis/pulmonary infiltrates	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Sinus	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Skin (celluli	1 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hemorrhage, GI - Abdomen NOS	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Small bowel N	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Upper airway	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hemorrhage, CNS	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Portal vein flow	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infection with Grade 3 or 4 neut - Urinary tract	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Bicarbonate, serum-low	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Vulva	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hemolysis	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with Grade 3 or 4 neut - Wound	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Infec with normal ANC or Grade 1/2 neut - Blood	0 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Hemoglobin	2 Participants with a given type of AE
Post-consolidation G.O.	Toxicity	Potassium, serum-high (hyperkalemia)	0 Participants with a given type of AE

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026

S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

2-year Disease-free Survival (DFS)

Complete Remission

Toxicity