NCT00057811 · OUTCOME

Grade ≥ 3 Stomatitis

Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma · Source last updated 2014-09-19

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

Measure: NUMBER
Unit: participants
Interval / dispersion: Not reported
Time frame: Up to 1 year

What was measured

The incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences

Analysis population: Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.

Groups in this outcome

Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)

Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.

Group C (Chemotherapy, Monoclonal Antibody Therapy)

Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.

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
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)	45
Group C (Chemotherapy, Monoclonal Antibody Therapy)	40

Reported measurements

Incidence of grade ≥ 3 stomatitis

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)	4	Not reported	Not reported	Not reported	Not reported
Group C (Chemotherapy, Monoclonal Antibody Therapy)	6	Not reported	Not reported	Not reported	Not reported

No incidence of grade ≥ 3 stomatitis

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)	41	Not reported	Not reported	Not reported	Not reported
Group C (Chemotherapy, Monoclonal Antibody Therapy)	34	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
4
group Id
OG001
value
6
title
Incidence of grade ≥ 3 stomatitis
categories
measurements
group Id
OG000
value
41
group Id
OG001
value
34
title
No incidence of grade ≥ 3 stomatitis

denoms

counts
group Id
OG000
value
45
group Id
OG001
value
40
units
Participants

description

groups

description
Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
id
OG000
title
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)
description
Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
id
OG001
title
Group C (Chemotherapy, Monoclonal Antibody Therapy)

param Type

NUMBER

population Description

Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.

reporting Status

POSTED

time Frame

Up to 1 year

title

Grade ≥ 3 Stomatitis

type

PRIMARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice