NCT00621244 · OUTCOME

Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X

A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies · Source last updated 2021-01-05

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

Measure: NUMBER
Unit: Percentages of participants
Interval / dispersion: Not reported
Time frame: Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years)

Analysis population: Full Analysis Set

Groups in this outcome

Arm 2, Group X (30 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)

Arm 2, Group X (45 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)

Arm 2, Group X (60 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)

Arm 2, Group X (80 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)

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
Arm 2, Group X (30 mg)	6
Arm 2, Group X (45 mg)	9
Arm 2, Group X (60 mg)	9
Arm 2, Group X (80 mg)	9

Reported measurements

Day 5 (total=4, 9, 6, 8)

Values in Percentages of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 2, Group X (30 mg)	50.0	Not reported	Not reported	Not reported	Not reported
Arm 2, Group X (45 mg)	88.9	Not reported	Not reported	Not reported	Not reported
Arm 2, Group X (60 mg)	83.3	Not reported	Not reported	Not reported	Not reported
Arm 2, Group X (80 mg)	100.0	Not reported	Not reported	Not reported	Not reported

Day 8 (total = 4, 7, 5, 7)

Values in Percentages of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 2, Group X (30 mg)	50.0	Not reported	Not reported	Not reported	Not reported
Arm 2, Group X (45 mg)	100.0	Not reported	Not reported	Not reported	Not reported
Arm 2, Group X (60 mg)	80.0	Not reported	Not reported	Not reported	Not reported
Arm 2, Group X (80 mg)	100.0	Not reported	Not reported	Not reported	Not reported

Day 10 (Total=3, 8, 5, 7)

Values in Percentages of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 2, Group X (30 mg)	33.3	Not reported	Not reported	Not reported	Not reported
Arm 2, Group X (45 mg)	37.5	Not reported	Not reported	Not reported	Not reported
Arm 2, Group X (60 mg)	80.0	Not reported	Not reported	Not reported	Not reported
Arm 2, Group X (80 mg)	100.0	Not reported	Not reported	Not reported	Not reported

Day 12 (Total=4, 6, 4, 8)

Values in Percentages of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 2, Group X (30 mg)	25.0	Not reported	Not reported	Not reported	Not reported
Arm 2, Group X (45 mg)	NA	Not reported	Not reported	Not reported	no patients with positive reading (greater than two fold increased when compared to baseline) at this time point in the dose group.
Arm 2, Group X (60 mg)	50.0	Not reported	Not reported	Not reported	Not reported
Arm 2, Group X (80 mg)	50.0	Not reported	Not reported	Not reported	Not reported

Day 15 (Total=4, 6, 2, 5)

Values in Percentages of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 2, Group X (30 mg)	75.0	Not reported	Not reported	Not reported	Not reported
Arm 2, Group X (45 mg)	50.0	Not reported	Not reported	Not reported	Not reported
Arm 2, Group X (60 mg)	100.0	Not reported	Not reported	Not reported	Not reported
Arm 2, Group X (80 mg)	60.0	Not reported	Not reported	Not reported	Not reported

End of Study (Total=1, 4, 2, 0)

Values in Percentages of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 2, Group X (30 mg)	100.0	Not reported	Not reported	Not reported	Not reported
Arm 2, Group X (45 mg)	75.0	Not reported	Not reported	Not reported	Not reported
Arm 2, Group X (60 mg)	50.0	Not reported	Not reported	Not reported	Not reported
Arm 2, Group X (80 mg)	0.0	Not reported	Not reported	Not reported	Not reported

Unscheduled (Total=2, 0, 0, 0)

Values in Percentages of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 2, Group X (30 mg)	50.0	Not reported	Not reported	Not reported	Not reported
Arm 2, Group X (45 mg)	NA	Not reported	Not reported	Not reported	No patients were analyzed for this arm.
Arm 2, Group X (60 mg)	NA	Not reported	Not reported	Not reported	No patients were analyzed for this arm.
Arm 2, Group X (80 mg)	NA	Not reported	Not reported	Not reported	No patients were analyzed for this arm.

Complete source fields

classes

categories
measurements
group Id
OG000
value
50.0
group Id
OG001
value
88.9
group Id
OG002
value
83.3
group Id
OG003
value
100.0
title
Day 5 (total=4, 9, 6, 8)
categories
measurements
group Id
OG000
value
50.0
group Id
OG001
value
100.0
group Id
OG002
value
80.0
group Id
OG003
value
100.0
title
Day 8 (total = 4, 7, 5, 7)
categories
measurements
group Id
OG000
value
33.3
group Id
OG001
value
37.5
group Id
OG002
value
80.0
group Id
OG003
value
100.0
title
Day 10 (Total=3, 8, 5, 7)
categories
measurements
group Id
OG000
value
25.0
comment
no patients with positive reading (greater than two fold increased when compared to baseline) at this time point in the dose group.
group Id
OG001
value
NA
group Id
OG002
value
50.0
group Id
OG003
value
50.0
title
Day 12 (Total=4, 6, 4, 8)
categories
measurements
group Id
OG000
value
75.0
group Id
OG001
value
50.0
group Id
OG002
value
100.0
group Id
OG003
value
60.0
title
Day 15 (Total=4, 6, 2, 5)
categories
measurements
group Id
OG000
value
100.0
group Id
OG001
value
75.0
group Id
OG002
value
50.0
group Id
OG003
value
0.0
title
End of Study (Total=1, 4, 2, 0)
categories
measurements
group Id
OG000
value
50.0
comment
No patients were analyzed for this arm.
group Id
OG001
value
NA
comment
No patients were analyzed for this arm.
group Id
OG002
value
NA
comment
No patients were analyzed for this arm.
group Id
OG003
value
NA
title
Unscheduled (Total=2, 0, 0, 0)

denoms

counts
group Id
OG000
value
6
group Id
OG001
value
9
group Id
OG002
value
9
group Id
OG003
value
9
units
Participants

groups

description
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
id
OG000
title
Arm 2, Group X (30 mg)
description
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
id
OG001
title
Arm 2, Group X (45 mg)
description
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
id
OG002
title
Arm 2, Group X (60 mg)
description
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
id
OG003
title
Arm 2, Group X (80 mg)

param Type

NUMBER

population Description

Full Analysis Set

reporting Status

POSTED

time Frame

Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years)

title

Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X

type

SECONDARY

unit Of Measure

Percentages of participants

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Preserved source evidence · Not medical advice