NCT00085709 · OUTCOME

Toxicity

S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML · Source last updated 2015-09-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: Participants with a given type of AE
Interval / dispersion: Not reported
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.

What was measured

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

Analysis population: Eligible patients who started therapy

Groups in this outcome

Ara-C+Daunomycin+Mylotarg

A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment

Ara-C+Daunomycin

A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment

Ara-C Consolidation

For patients who achieved a CR during induction, patients may receive up to 3 28 day cycles of treatment with Ara-C consolidation. Patients who relapse from CR are taken off protocol consolidation treatment.

Post-consolidation G.O.

For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Ara-C+Daunomycin+Mylotarg	293
Ara-C+Daunomycin	294
Ara-C Consolidation	377
Post-consolidation G.O.	79

Reported measurements

ALT, SGPT (serum glutamic pyruvic transaminase)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	29	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	11	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	22	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	2	Not reported	Not reported	Not reported	Not reported

AST, SGOT (serum glut. oxaloacetic transaminase)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	32	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	11	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	17	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	2	Not reported	Not reported	Not reported	Not reported

Acidosis (metabolic or respiratory)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	2	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	2	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Adult respiratory distress syndrome (ARDS)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	7	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	2	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Albumin, serum-low (hypoalbuminemia)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	15	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	10	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	3	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Alkaline phosphatase

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	3	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	2	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	2	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Alkalosis (metabolic or respiratory)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Allergic reaction/hypersens. (inc drug fever)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	6	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Amylase

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Anorexia

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	14	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	13	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	2	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Apnea

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Ataxia (incoordination)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	2	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Bicarbonate, serum-low

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Bilirubin (hyperbilirubinemia)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	14	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	11	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	4	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Blood/Bone Marrow-Other (Specify)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	2	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Bronchospasm, wheezing

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Calcium, serum-low (hypocalcemia)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	13	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	7	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	3	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Cardiac Arrhythmia-Other (Specify)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Cardiac General-Other (Specify)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	2	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Cardiac troponin I (cTnI)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Cardiac troponin T (cTnT)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	3	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Cardiac-ischemia/infarction

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	2	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	4	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Colitis

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	2	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	6	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Colitis, infectious (e.g., Clostridium difficile)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	8	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	10	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	4	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Confusion

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	3	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Constipation

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Cough

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Creatinine

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	3	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	2	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

DIC (disseminated intravascular coagulation)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	2	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Death not assoc with CTCAE term-Multi-organ failu

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Dehydration

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	1	Not reported	Not reported	Not reported	Not reported

Diarrhea

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	5	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	19	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	4	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Distention/bloating, abdominal

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Dizziness

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	2	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	3	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Dysphagia (difficulty swallowing)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Dyspnea (shortness of breath)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	10	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	6	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	10	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Edema, larynx

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Edema: limb

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Edema: viscera

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Enteritis (inflammation of the small bowel)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Esophagitis

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	3	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Fatigue (asthenia, lethargy, malaise)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	24	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	25	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	22	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	4	Not reported	Not reported	Not reported	Not reported

Febrile neutropenia

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	178	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	196	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	183	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	22	Not reported	Not reported	Not reported	Not reported

Fever (in the absence of neutropenia)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	6	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	8	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	16	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	1	Not reported	Not reported	Not reported	Not reported

Fistula, GI - Rectum

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Fistula, GU - Vagina

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Flu-like syndrome

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

GGT (gamma-glutamyl transpeptidase)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	4	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Glucose, serum-high (hyperglycemia)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	22	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	12	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	15	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	2	Not reported	Not reported	Not reported	Not reported

Glucose, serum-low (hypoglycemia)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hematoma

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hemoglobin

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	101	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	87	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	144	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	2	Not reported	Not reported	Not reported	Not reported

Hemolysis

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hemorrhage, CNS

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	5	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hemorrhage, GI - Abdomen NOS

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hemorrhage, GI - Jejunum

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hemorrhage, GI - Lower GI NOS

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hemorrhage, GI - Oral cavity

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	2	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hemorrhage, GI - Rectum

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hemorrhage, GU - Bladder

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	2	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hemorrhage, GU - Kidney

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hemorrhage, GU - Urinary NOS

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hemorrhage, GU - Uterus

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	2	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hemorrhage, GU - Vagina

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hemorrhage, pulmonary/upper respiratory - Lung

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	5	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hemorrhage, pulmonary/upper respiratory - Nose

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	3	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	4	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hemorrhage/Bleeding-Other (Specify)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	8	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	5	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	12	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hepatobiliary/Pancreas-Other (Specify)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	3	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hiccoughs (hiccups, singultus)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hypertension

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	2	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	3	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	2	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Hypotension

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	5	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	4	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	1	Not reported	Not reported	Not reported	Not reported

Hypoxia

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	8	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	2	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	6	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Abdomen NOS

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Anal/perianal

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	2	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	4	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Appendix

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Bladder (urin

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	2	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	4	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Blood

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	30	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	25	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	47	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	4	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Bone (osteomy

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Brain + Spina

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Bronchus

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Catheter-rela

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	5	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	6	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	13	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	2	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Cecum

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Colon

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	5	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	2	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	2	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Dental-tooth

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	2	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	3	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Heart (endoca

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Lip/perioral

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Liver

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Lung (pneumon

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	22	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	27	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	22	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Meninges (men

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infect with Grade 3 or 4 neut - Mucosa

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	2	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Nerve-periphe

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Oral cavity-g

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	2	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	3	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	2	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Pelvis NOS

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut- Pharynx

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	1	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Rectum

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Sinus

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	2	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	3	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	2	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Skin (celluli

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	4	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	3	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	9	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	1	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Small bowel N

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Upper airway

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infection with Grade 3 or 4 neut - Urinary tract

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	6	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	6	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	6	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Vulva

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with Grade 3 or 4 neut - Wound

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with normal ANC or Grade 1/2 neut - Blood

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	6	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with norm ANC or Gr 1/2 neut, Catheter-rel

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	4	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with norm ANC or Grade 1/2 neut - Colon

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with norm ANC or Gr 1/2 neutr- Dental-tooth

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with norm ANC or Gr 1/2 neut - Heart

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with norm ANC or Gr 1/2 neutrophils - Liver

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with norm ANC or Gr 1/2 neut-Lung (pneumoni)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	6	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	9	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with norm ANC or Gr 1/2 neut - Muscle

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Inf with norm ANC or Gr 1/2 neut-Oral cavity-gums

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with norm ANC or Gr 1/2 neut - Scrotum

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with norm ANC or Gr 1/2 neut-Skin

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	2	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infec with norm ANC or Gr 1/2 neut-Urinary tract

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infection with unknown ANC - Blood

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	3	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	7	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infection with unknown ANC - Catheter-related

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	3	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infection with unknown ANC - Dental-tooth

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infection with unknown ANC - Joint

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	2	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infection with unknown ANC - Liver

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infection with unknown ANC - Lung (pneumonia)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	2	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	2	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infection with unknown ANC - Mucosa

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infection with unknown ANC - Sinus

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infection with unknown ANC - Skin (cellulitis)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	4	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	3	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	3	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infection with unknown ANC - Urinary tract NOS

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infection with unknown ANC - Wound

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Infection-Other (Specify)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	4	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	4	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	4	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Left ventricular diastolic dysfunction

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Left ventricular systolic dysfunction

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	2	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Leukocytes (total WBC)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	106	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	96	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	151	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	41	Not reported	Not reported	Not reported	Not reported

Leukoencephalopathy (radiolographic findings)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Liver dysfunction/failure (clinical)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	4	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Lymphopenia

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	21	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	23	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	50	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	4	Not reported	Not reported	Not reported	Not reported

Magnesium, serum-low (hypomagnesemia)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Metabolic/Laboratory-Other (Specify)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	3	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	5	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	4	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Mood alteration - anxiety

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Mood alteration - depression

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Mucositis/stomatitis (clinical exam) - Esophagus

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Mucositis/stomatitis (clinical exam) - Large bowel

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Mucositis/stomatitis (clinical exam) - Larynx

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Mucositis/stomatitis (clinical exam) - Oral cavity

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	6	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	11	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	2	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Mucositis/stomatitis (clinical exam) - Pharynx

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	2	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	2	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Mucositis/stomatitis (func/sympt) - Esophagus

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	2	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Mucositis/stomatitis (func/sympt)- Oral cavity

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	4	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	9	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Mucositis/stomatitis (func/sympt) - Pharynx

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	2	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Muscle weakness (func/sym, Whole body/generalized

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	2	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Nasal cavity/paranasal sinus reactions

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Nausea

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	7	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	13	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	7	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	1	Not reported	Not reported	Not reported	Not reported

Necrosis, GI - Rectum

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Neurology-Other (Specify)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Neuropathy: motor

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	2	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Neuropathy: sensory

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Neutrophils/granulocytes (ANC/AGC)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	111	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	110	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	193	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	43	Not reported	Not reported	Not reported	Not reported

Nystagmus

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Obstruction/stenosis of airway - Trachea

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Ocular/Visual-Other (Specify)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Opportunistic infec assoc with Gr 2 lymphopenia

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	2	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	1	Not reported	Not reported	Not reported	Not reported

PTT (Partial thromboplastin time)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Pain - Abdomen NOS

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	8	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	5	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	3	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Pain - Anus

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	1	Not reported	Not reported	Not reported	Not reported

Pain - Back

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	1	Not reported	Not reported	Not reported	Not reported

Pain - Bone

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	4	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Pain - Chest/thorax NOS

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	2	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	2	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Pain - Extremity-limb

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	1	Not reported	Not reported	Not reported	Not reported

Pain - Eye

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Pain - Head/headache

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	8	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	8	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	1	Not reported	Not reported	Not reported	Not reported

Pain - Joint

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Pain - Muscle

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Pain - Oral-gums

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Pain - Rectum

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	1	Not reported	Not reported	Not reported	Not reported

Pain - Throat/pharynx/larynx

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Pain-Other (Specify)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Pancreatic endocrine: glucose intolerance

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Perforation, GI - Colon

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Pericardial effusion (non-malignant)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Pericarditis

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Petechiae/purpura

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	6	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	2	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	3	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	1	Not reported	Not reported	Not reported	Not reported

Phosphate, serum-low (hypophosphatemia)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	10	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	9	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	6	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	1	Not reported	Not reported	Not reported	Not reported

Platelets

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	145	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	130	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	226	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	40	Not reported	Not reported	Not reported	Not reported

Pleural effusion (non-malignant)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	3	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Pneumonitis/pulmonary infiltrates

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	3	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	5	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Portal vein flow

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	2	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Potassium, serum-high (hyperkalemia)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	4	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	2	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Potassium, serum-low (hypokalemia)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	21	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	15	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	19	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	3	Not reported	Not reported	Not reported	Not reported

Proctitis

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Pulmonary/Upper Respiratory-Other (Specify)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Rash/desquamation

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	6	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	9	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Renal failure

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	8	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	6	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Rigors/chills

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Seroma

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Serum sickness

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	1	Not reported	Not reported	Not reported	Not reported

Sodium, serum-high (hypernatremia)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	2	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Sodium, serum-low (hyponatremia)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	8	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	15	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	4	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Somnolence/depressed level of consciousness

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Atrial fibrillation

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Sinus tachycardia

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Supraventricular arrhythmia NOS

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Syncope (fainting)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	3	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	4	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Syndromes-Other (Specify)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	2	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Thrombosis/embolism (vascular access-related)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Thrombosis/thrombus/embolism

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	4	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	4	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	4	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Thrombotic microangiopathy

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Tumor lysis syndrome

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	2	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	2	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Typhlitis (cecal inflammation)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	3	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	4	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Uric acid, serum-high (hyperuricemia)

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Vasovagal episode

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	1	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Ventricular arrhythmia - Ventricular fibrillation

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	1	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	0	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Vision-blurred vision

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	0	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	1	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	0	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	0	Not reported	Not reported	Not reported	Not reported

Vomiting

Values in Participants with a given type of AE · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ara-C+Daunomycin+Mylotarg	2	Not reported	Not reported	Not reported	Not reported
Ara-C+Daunomycin	5	Not reported	Not reported	Not reported	Not reported
Ara-C Consolidation	5	Not reported	Not reported	Not reported	Not reported
Post-consolidation G.O.	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
29
group Id
OG001
value
11
group Id
OG002
value
22
group Id
OG003
value
2
title
ALT, SGPT (serum glutamic pyruvic transaminase)
categories
measurements
group Id
OG000
value
32
group Id
OG001
value
11
group Id
OG002
value
17
group Id
OG003
value
2
title
AST, SGOT (serum glut. oxaloacetic transaminase)
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
0
title
Acidosis (metabolic or respiratory)
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
0
title
Adult respiratory distress syndrome (ARDS)
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
10
group Id
OG002
value
3
group Id
OG003
value
0
title
Albumin, serum-low (hypoalbuminemia)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
0
title
Alkaline phosphatase
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
title
Alkalosis (metabolic or respiratory)
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Allergic reaction/hypersens. (inc drug fever)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
Amylase
categories
measurements
group Id
OG000
value
14
group Id
OG001
value
13
group Id
OG002
value
2
group Id
OG003
value
0
title
Anorexia
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
Apnea
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
0
title
Ataxia (incoordination)

denoms

counts
group Id
OG000
value
293
group Id
OG001
value
294
group Id
OG002
value
377
group Id
OG003
value
79
units
Participants

description

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

groups

description
A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
id
OG000
title
Ara-C+Daunomycin+Mylotarg
description
A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
id
OG001
title
Ara-C+Daunomycin
description
For patients who achieved a CR during induction, patients may receive up to 3 28 day cycles of treatment with Ara-C consolidation. Patients who relapse from CR are taken off protocol consolidation treatment.
id
OG002
title
Ara-C Consolidation
description
For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
id
OG003
title
Post-consolidation G.O.

param Type

NUMBER

population Description

Eligible patients who started therapy

reporting Status

POSTED

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.

title

Toxicity

type

SECONDARY

unit Of Measure

Participants with a given type of AE

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice