NCT03526250 · ADVERSE EVENTS

Adverse events

Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial) · Source last updated 2026-04-03

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

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years. All-Cause Mortality monitored/assessed up to 5 years
Other-event reporting threshold: 0%

Adverse event (AE) reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs/CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible and non-treated patients are excluded from reporting of AEs.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Palbociclib) Patients receive palbociclib PO QD on days 1-21. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.	8 / 20	19 / 20	19 / 20

Group identifiers: EG000: Treatment (Palbociclib)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
20
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Neuralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Pleural effusion

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
10
num At Risk
20
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
5
num At Risk
20
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
4
num At Risk
20
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Gastroesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
4
num At Risk
20
term
Mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
6
num At Risk
20
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Stomach pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
6
num At Risk
20
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Fever

Complete source fields

description

event Groups

deaths Num Affected
19
deaths Num At Risk
20
description
Patients receive palbociclib PO QD on days 1-21. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
19
other Num At Risk
20
serious Num Affected
8
serious Num At Risk
20
title
Treatment (Palbociclib)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
10
num At Risk
20
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
5
num At Risk
20
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
4
num At Risk
20
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Gastroesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
4
num At Risk
20
term
Mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
6
num At Risk
20
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Stomach pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
6
num At Risk
20
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Fever

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
20
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Neuralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Pleural effusion

time Frame

Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years. All-Cause Mortality monitored/assessed up to 5 years

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Preserved source evidence · Not medical advice