Phase 2: 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 2 per group: Ewings Sarcoma = 14 weeks (3-31), Neuroblastoma = 7 weeks (3-23), Rhabdomyosarcoma = 5 weeks (1-13). Participants were followed for 28 days after discontinuing treatment for safety and monitoring of AEs.
What was measured
An 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 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 the AEs was graded according to the Common Terminology Criteria for Adverse Events, Version 4.0. Participants were followed for 28 days after discontinuing treatment for safety and monitoring of AEs.
Analysis population: Safety Population: all participants who took at least 1 dose of study drug.
Groups in this outcome
Phase 2: Ewing's Sarcoma
Participants with Ewing's sarcoma: nab-paclitaxel at the RP2D (240 mg/m\^2 in participants weighing \> 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.
Phase 2: Neuroblastoma
Participants with neuroblastoma: nab-paclitaxel at the RP2D (240 mg/m\^2 in participants weighing \> 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.
Phase 2: Rhabdomyosarcoma
Participants with rhabdomyosarcoma: nab-paclitaxel at the RP2D (240 mg/m\^2 in participants weighing \> 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.
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 2: Ewing's Sarcoma
14
Phase 2: Neuroblastoma
14
Phase 2: Rhabdomyosarcoma
14
Reported measurements
TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2: Ewing's Sarcoma
14
Not reported
Not reported
Not reported
Not reported
Phase 2: Neuroblastoma
14
Not reported
Not reported
Not reported
Not reported
Phase 2: Rhabdomyosarcoma
14
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 2: Ewing's Sarcoma
13
Not reported
Not reported
Not reported
Not reported
Phase 2: Neuroblastoma
12
Not reported
Not reported
Not reported
Not reported
Phase 2: Rhabdomyosarcoma
12
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 2: Ewing's Sarcoma
12
Not reported
Not reported
Not reported
Not reported
Phase 2: Neuroblastoma
13
Not reported
Not reported
Not reported
Not reported
Phase 2: Rhabdomyosarcoma
12
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 2: Ewing's Sarcoma
9
Not reported
Not reported
Not reported
Not reported
Phase 2: Neuroblastoma
9
Not reported
Not reported
Not reported
Not reported
Phase 2: Rhabdomyosarcoma
10
Not reported
Not reported
Not reported
Not reported
Serious TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2: Ewing's Sarcoma
6
Not reported
Not reported
Not reported
Not reported
Phase 2: Neuroblastoma
6
Not reported
Not reported
Not reported
Not reported
Phase 2: Rhabdomyosarcoma
11
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 2: Ewing's Sarcoma
2
Not reported
Not reported
Not reported
Not reported
Phase 2: Neuroblastoma
2
Not reported
Not reported
Not reported
Not reported
Phase 2: Rhabdomyosarcoma
6
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 2: Ewing's Sarcoma
3
Not reported
Not reported
Not reported
Not reported
Phase 2: Neuroblastoma
1
Not reported
Not reported
Not reported
Not reported
Phase 2: Rhabdomyosarcoma
3
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 2: Ewing's Sarcoma
1
Not reported
Not reported
Not reported
Not reported
Phase 2: Neuroblastoma
0
Not reported
Not reported
Not reported
Not reported
Phase 2: Rhabdomyosarcoma
3
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 2: Ewing's Sarcoma
4
Not reported
Not reported
Not reported
Not reported
Phase 2: Neuroblastoma
5
Not reported
Not reported
Not reported
Not reported
Phase 2: Rhabdomyosarcoma
4
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 2: Ewing's Sarcoma
4
Not reported
Not reported
Not reported
Not reported
Phase 2: Neuroblastoma
4
Not reported
Not reported
Not reported
Not reported
Phase 2: Rhabdomyosarcoma
4
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 2: Ewing's Sarcoma
5
Not reported
Not reported
Not reported
Not reported
Phase 2: Neuroblastoma
3
Not reported
Not reported
Not reported
Not reported
Phase 2: Rhabdomyosarcoma
4
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 2: Ewing's Sarcoma
3
Not reported
Not reported
Not reported
Not reported
Phase 2: Neuroblastoma
3
Not reported
Not reported
Not reported
Not reported
Phase 2: Rhabdomyosarcoma
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 2: Ewing's Sarcoma
0
Not reported
Not reported
Not reported
Not reported
Phase 2: Neuroblastoma
2
Not reported
Not reported
Not reported
Not reported
Phase 2: Rhabdomyosarcoma
3
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 2: Ewing's Sarcoma
0
Not reported
Not reported
Not reported
Not reported
Phase 2: Neuroblastoma
0
Not reported
Not reported
Not reported
Not reported
Phase 2: Rhabdomyosarcoma
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
14
group Id
OG001
value
14
group Id
OG002
value
14
title
TEAE
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
12
group Id
OG002
value
12
title
Treatment-related (TR) TEAE
categories
measurements
group Id
OG000
value
12
group Id
OG001
value
13
group Id
OG002
value
12
title
Grade 3 or 4 TEAE
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
9
group Id
OG002
value
10
title
TR Grade 3 or 4 TEAE
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
6
group Id
OG002
value
11
title
Serious TEAE
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
6
title
TR Serious TEAE
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
1
group Id
OG002
value
3
title
TEAE Leading to Drug Discontinuation
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
3
title
TR TEAE Leading to Drug Discontinuation
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
5
group Id
OG002
value
4
title
TEAE Leading to Dose Reduction
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
4
group Id
OG002
value
4
title
TR TEAE Leading to Dose Reduction
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
3
group Id
OG002
value
4
title
TEAE Leading to Drug Interruption
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
2
title
TR TEAE Leading to Drug Interruption
denoms
counts
group Id
OG000
value
14
group Id
OG001
value
14
group Id
OG002
value
14
units
Participants
description
An 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 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 the AEs was graded according to the Common Terminology Criteria for Adverse Events, Version 4.0. Participants were followed for 28 days after discontinuing treatment for safety and monitoring of AEs.
groups
description
Participants with Ewing's sarcoma: nab-paclitaxel at the RP2D (240 mg/m\^2 in participants weighing \> 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.
id
OG000
title
Phase 2: Ewing's Sarcoma
description
Participants with neuroblastoma: nab-paclitaxel at the RP2D (240 mg/m\^2 in participants weighing \> 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.
id
OG001
title
Phase 2: Neuroblastoma
description
Participants with rhabdomyosarcoma: nab-paclitaxel at the RP2D (240 mg/m\^2 in participants weighing \> 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.
id
OG002
title
Phase 2: Rhabdomyosarcoma
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 2 per group: Ewings Sarcoma = 14 weeks (3-31), Neuroblastoma = 7 weeks (3-23), Rhabdomyosarcoma = 5 weeks (1-13). Participants were followed for 28 days after discontinuing treatment for safety and monitoring of AEs.
title
Phase 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Triangle