Trial · NCT01442376

Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients

NCT01442376, Phase 3, Completed, Helsinn Healthcare SA; results first posted 2014-07-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients. Trials, record NCT01442376. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01442376

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients
NCT number: NCT01442376
Status: Completed
Phases: Phase 3
Enrollment: 502 participants, actual
Lead sponsor: Helsinn Healthcare SA
Conditions: Chemotherapy-Induced Nausea and Vomiting
Interventions: Palonosetron, Palonosetron, Ondansetron, Placebo to Ondansetron, Placebo to Ondansetron, Placebo to Palonosetron
First posted: 2011-09-28
Last updated: 2014-08-07
Results first posted: 2014-07-28

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1	0 to 24 hours after T0	Complete Response (CR) was defined as no vomiting, no retching, and no use of antiemetic rescue medication from 0 to 24 hours (acute phase) after T0 (start of administration of the most emetogenic chemotherapy) during first cycle. Time 0 (T0) is defined as the time when the patient starts the first cycle of chemotherapy.
Secondary	Proportion of Patients With Complete Response >24 to 120 Hours (Delayed Phase) in Cycle 1	from >24 to 120 hours (delayed phase) after T0	Complete Response (CR) was defined as no vomiting, no retching, and no use of antiemetic rescue medication from \>24 to 120 hours (delayed phase) after T0 (start of administration of the most emetogenic chemotherapy) during first cycle.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1	0 to 24 hours after T0	Full Analysis Set (FAS) population	percentage of patients	NUMBER
SECONDARY	Proportion of Patients With Complete Response >24 to 120 Hours (Delayed Phase) in Cycle 1	from >24 to 120 hours (delayed phase) after T0	Full Analysis Set (FAS) population.	percentage of patients	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1	Palonosetron 10 mcg/kg	54.2	95% Confidence Interval 46.3 to 61.9	percentage of patients
Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1	Palonosetron 20 mcg/kg	59.4	95% Confidence Interval 51.5 to 66.9	percentage of patients
Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1	Ondansetron	58.6	95% Confidence Interval 50.6 to 66.2	percentage of patients
Proportion of Patients With Complete Response >24 to 120 Hours (Delayed Phase) in Cycle 1	Palonosetron 10 mcg/kg	28.9	95% Confidence Interval 22.3 to 36.5	percentage of patients
Proportion of Patients With Complete Response >24 to 120 Hours (Delayed Phase) in Cycle 1	Palonosetron 20 mcg/kg	38.8	95% Confidence Interval 31.4 to 46.7	percentage of patients
Proportion of Patients With Complete Response >24 to 120 Hours (Delayed Phase) in Cycle 1	Ondansetron	28.4	95% Confidence Interval 21.7 to 36.1	percentage of patients

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Palonosetron 10 mcg/kg	169
Overall Study	STARTED	Palonosetron 20 mcg/kg	169
Overall Study	STARTED	Ondansetron	164
Overall Study	COMPLETED	Palonosetron 10 mcg/kg	166
Overall Study	COMPLETED	Palonosetron 20 mcg/kg	160
Overall Study	COMPLETED	Ondansetron	159
Overall Study	NOT COMPLETED	Palonosetron 10 mcg/kg	3
Overall Study	NOT COMPLETED	Palonosetron 20 mcg/kg	9
Overall Study	NOT COMPLETED	Ondansetron	5

Source ClinicalTrials.gov

Adverse events387

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Palonosetron 10 mcg/kg	65	167	107
other	Anaemia	Blood and lymphatic system disorders	Palonosetron 20 mcg/kg	60	163	89
other	Anaemia	Blood and lymphatic system disorders	Ondansetron	61	164	105
other	Thrombocytopenia	Blood and lymphatic system disorders	Palonosetron 10 mcg/kg	35	167	69
other	Thrombocytopenia	Blood and lymphatic system disorders	Palonosetron 20 mcg/kg	33	163	61
other	Thrombocytopenia	Blood and lymphatic system disorders	Ondansetron	37	164	90
other	Leukopenia	Blood and lymphatic system disorders	Palonosetron 10 mcg/kg	37	167	74
other	Leukopenia	Blood and lymphatic system disorders	Palonosetron 20 mcg/kg	27	163	59
other	Leukopenia	Blood and lymphatic system disorders	Ondansetron	43	164	104
other	Neutropenia	Blood and lymphatic system disorders	Palonosetron 10 mcg/kg	35	167	60

1 to 10 of 387Source ClinicalTrials.gov

See all 387 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Palonosetron 10 mcg/kg
Total, all-cause mortality	Palonosetron 20 mcg/kg
Total, all-cause mortality	Ondansetron
Total, other adverse events	Palonosetron 10 mcg/kg	143	167
Total, other adverse events	Palonosetron 20 mcg/kg	130	163
Total, other adverse events	Ondansetron	145	164
Total, serious adverse events	Palonosetron 10 mcg/kg	68	167
Total, serious adverse events	Palonosetron 20 mcg/kg	62	163
Total, serious adverse events	Ondansetron	70	164

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26795844	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01442376

GET https://conductscience.org/api/trials/v1/NCT01442376/events?page=2

API reference For AI assistants