NCT01831232 · OUTCOME

Rate of Complete Remission (CR), Remission With Incomplete Blood Count Recovery (CRi) and Partial Remission (PR)

Idarubicin, Cytarabine, and Pravastatin Sodium in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes · Source last updated 2017-11-17

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: 35 days

What was measured

Complete remission (CR) - includes patients with good CR and CR with minimal residual disease (MRD); remission with incomplete blood count recovery (CRi), partial remission (PR)

Analysis population: All patient who received IAP treatment were assessed for response. The number of participants with CR, CRi and PR are included in the table below.

Groups in this outcome

Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)

Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. pravastatin sodium: Given PO idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies

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
Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)	24

Reported measurements

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)	15	Not reported	Not reported	Not reported	Not reported

CRi

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)	2	Not reported	Not reported	Not reported	Not reported

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
15
title
CR
categories
measurements
group Id
OG000
value
2
title
CRi
categories
measurements
group Id
OG000
value
0
title
PR

denoms

counts
group Id
OG000
value
24
units
Participants

description

Complete remission (CR) - includes patients with good CR and CR with minimal residual disease (MRD); remission with incomplete blood count recovery (CRi), partial remission (PR)

groups

description
Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. pravastatin sodium: Given PO idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies
id
OG000
title
Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)

param Type

COUNT_OF_PARTICIPANTS

population Description

All patient who received IAP treatment were assessed for response. The number of participants with CR, CRi and PR are included in the table below.

reporting Status

POSTED

time Frame

35 days

title

Rate of Complete Remission (CR), Remission With Incomplete Blood Count Recovery (CRi) and Partial Remission (PR)

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice