Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Study to Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors · Source last updated 2019-12-27
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
Median treatment duration in Phase 1 was 7.0 weeks, with minimum and maximum duration of 1 and 49 weeks, respectively. Participants were followed for 28 days after discontinuing treatment for safety and monitoring of AEs.
What was measured
An adverse event (AE) was defined as any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE (SAE) is any AE occurring at any dose that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAEs were defined as AEs that began or worsened in severity on or after the date of the first dose of study drug and within 28 days of the date of the last dose of study drug. The severity of an AE was graded according to the CTCAE, Version 4.0.
Analysis population: Safety Population: all participants who took at least 1 dose of study drug.
Groups in this outcome
Phase 1: Nab-Paclitaxel 120 mg/m^2
nab-paclitaxel 120 mg/m\^2 intravenously (IV) on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the recommended phase 2 dose (RP2D).
Phase 1: Nab-Paclitaxel 150 mg/m^2
nab-paclitaxel 150 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
Phase 1: Nab-Paclitaxel 180 mg/m^2
nab-paclitaxel 180 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
Phase 1: Nab-Paclitaxel 210 mg/m^2
nab-paclitaxel 210 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
Phase 1: Nab-Paclitaxel 240 mg/m^2
nab-paclitaxel 240 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
Phase 1: Nab-Paclitaxel 270 mg/m^2
nab-paclitaxel 270 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
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
Phase 1: Nab-Paclitaxel 120 mg/m^2
16
Phase 1: Nab-Paclitaxel 150 mg/m^2
8
Phase 1: Nab-Paclitaxel 180 mg/m^2
14
Phase 1: Nab-Paclitaxel 210 mg/m^2
11
Phase 1: Nab-Paclitaxel 240 mg/m^2
8
Phase 1: Nab-Paclitaxel 270 mg/m^2
7
Reported measurements
TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Nab-Paclitaxel 120 mg/m^2
16
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 150 mg/m^2
8
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 180 mg/m^2
14
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 210 mg/m^2
11
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 240 mg/m^2
8
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 270 mg/m^2
7
Not reported
Not reported
Not reported
Not reported
Treatment-related (TR) TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Nab-Paclitaxel 120 mg/m^2
14
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 150 mg/m^2
8
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 180 mg/m^2
12
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 210 mg/m^2
11
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 240 mg/m^2
7
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 270 mg/m^2
7
Not reported
Not reported
Not reported
Not reported
Grade 3 or 4 TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Nab-Paclitaxel 120 mg/m^2
13
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 150 mg/m^2
8
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 180 mg/m^2
10
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 210 mg/m^2
10
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 240 mg/m^2
8
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 270 mg/m^2
7
Not reported
Not reported
Not reported
Not reported
TR Grade 3 or 4 TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Nab-Paclitaxel 120 mg/m^2
9
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 150 mg/m^2
7
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 180 mg/m^2
7
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 210 mg/m^2
9
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 240 mg/m^2
7
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 270 mg/m^2
7
Not reported
Not reported
Not reported
Not reported
Serious TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Nab-Paclitaxel 120 mg/m^2
10
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 150 mg/m^2
7
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 180 mg/m^2
6
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 210 mg/m^2
5
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 240 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 270 mg/m^2
4
Not reported
Not reported
Not reported
Not reported
TR Serious TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Nab-Paclitaxel 120 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 150 mg/m^2
4
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 180 mg/m^2
4
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 210 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 240 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 270 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
TEAE Leading to Drug Discontinuation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Nab-Paclitaxel 120 mg/m^2
4
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 150 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 180 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 210 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 240 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 270 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
TR TEAE Leading to Drug Discontinuation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Nab-Paclitaxel 120 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 150 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 180 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 210 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 240 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 270 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
TEAE Leading to Dose Reduction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Nab-Paclitaxel 120 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 150 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 180 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 210 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 240 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 270 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
TR TEAE Leading to Dose Reduction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Nab-Paclitaxel 120 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 150 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 180 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 210 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 240 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 270 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
TEAE Leading to Drug Interruption
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Nab-Paclitaxel 120 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 150 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 180 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 210 mg/m^2
4
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 240 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 270 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
TR TEAE Leading to Drug Interruption
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Nab-Paclitaxel 120 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 150 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 180 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 210 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 240 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 270 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
TEAE Leading to Death
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Nab-Paclitaxel 120 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 150 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 180 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 210 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 240 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 270 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
TR TEAE Leading to Death
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Nab-Paclitaxel 120 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 150 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 180 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 210 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 240 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Nab-Paclitaxel 270 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
16
group Id
OG001
value
8
group Id
OG002
value
14
group Id
OG003
value
11
group Id
OG004
value
8
group Id
OG005
value
7
title
TEAE
categories
measurements
group Id
OG000
value
14
group Id
OG001
value
8
group Id
OG002
value
12
group Id
OG003
value
11
group Id
OG004
value
7
group Id
OG005
value
7
title
Treatment-related (TR) TEAE
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
8
group Id
OG002
value
10
group Id
OG003
value
10
group Id
OG004
value
8
group Id
OG005
value
7
title
Grade 3 or 4 TEAE
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
7
group Id
OG002
value
7
group Id
OG003
value
9
group Id
OG004
value
7
group Id
OG005
value
7
title
TR Grade 3 or 4 TEAE
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
7
group Id
OG002
value
6
group Id
OG003
value
5
group Id
OG004
value
3
group Id
OG005
value
4
title
Serious TEAE
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
4
group Id
OG002
value
4
group Id
OG003
value
2
group Id
OG004
value
1
group Id
OG005
value
3
title
TR Serious TEAE
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
1
group Id
OG004
value
2
group Id
OG005
value
2
title
TEAE Leading to Drug Discontinuation
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
2
group Id
OG005
value
2
title
TR TEAE Leading to Drug Discontinuation
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
2
group Id
OG003
value
1
group Id
OG004
value
3
group Id
OG005
value
3
title
TEAE Leading to Dose Reduction
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
2
group Id
OG003
value
1
group Id
OG004
value
3
group Id
OG005
value
3
title
TR TEAE Leading to Dose Reduction
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
3
group Id
OG003
value
4
group Id
OG004
value
3
group Id
OG005
value
2
title
TEAE Leading to Drug Interruption
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
3
group Id
OG004
value
3
group Id
OG005
value
2
title
TR TEAE Leading to Drug Interruption
denoms
counts
group Id
OG000
value
16
group Id
OG001
value
8
group Id
OG002
value
14
group Id
OG003
value
11
group Id
OG004
value
8
group Id
OG005
value
7
units
Participants
description
An adverse event (AE) was defined as any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE (SAE) is any AE occurring at any dose that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAEs were defined as AEs that began or worsened in severity on or after the date of the first dose of study drug and within 28 days of the date of the last dose of study drug. The severity of an AE was graded according to the CTCAE, Version 4.0.
groups
description
nab-paclitaxel 120 mg/m\^2 intravenously (IV) on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the recommended phase 2 dose (RP2D).
id
OG000
title
Phase 1: Nab-Paclitaxel 120 mg/m^2
description
nab-paclitaxel 150 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
id
OG001
title
Phase 1: Nab-Paclitaxel 150 mg/m^2
description
nab-paclitaxel 180 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
id
OG002
title
Phase 1: Nab-Paclitaxel 180 mg/m^2
description
nab-paclitaxel 210 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
id
OG003
title
Phase 1: Nab-Paclitaxel 210 mg/m^2
description
nab-paclitaxel 240 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
id
OG004
title
Phase 1: Nab-Paclitaxel 240 mg/m^2
description
nab-paclitaxel 270 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
id
OG005
title
Phase 1: Nab-Paclitaxel 270 mg/m^2
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Population: all participants who took at least 1 dose of study drug.
reporting Status
POSTED
time Frame
Median treatment duration in Phase 1 was 7.0 weeks, with minimum and maximum duration of 1 and 49 weeks, respectively. Participants were followed for 28 days after discontinuing treatment for safety and monitoring of AEs.
title
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Triangle