Trial · NCT01459653

Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor

NCT01459653, Completed, Sandoz; results first posted 2015-07-07

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor. Trials, record NCT01459653. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01459653

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Trial

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

Title: Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor
NCT number: NCT01459653
Status: Completed
Enrollment: 1,496 participants, actual
Lead sponsor: Sandoz
Conditions: Febrile Neutropenia, Cancer, Breast Cancer, Ovarian Cancer, Lung Cancer, Prostate Cancer, Multiple Myeloma, Bladder Cancer, B-cell Lymphoma
First posted: 2011-10-25
Last updated: 2016-01-11
Results first posted: 2015-07-07

Source ClinicalTrials.gov

Registered outcomes93

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

List	Outcome	Time frame	Description
Primary	Chemotherapy Toxicity (%FN Risk)	Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.	Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. Chemotherapy regimens were classified for FN risk (\<10% risk, 10-20% risk or \>20% risk) according to the published rates in the EORTC Guidelines under consideration of agent(s) and schedules. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;
Primary	Cancer Treatment Type - Ever Received During Study	All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days	Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;
Primary	Fever and Infections Ever During the Study	All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days	Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;
Primary	Clinical Events Ever During Study (Frequency Threshold: 5%)	All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days	Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia
Primary	Type of EP2006 Prophylaxis	All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Primary	Type of EP2006 Prophylaxis by Gender	All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Primary	Type of EP 2006 Prophylaxis by Age Group	All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Primary	Type of EP 2006 Prophylaxis by Tumor Type	All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Primary	Concomitant Antibiotic Prophylaxis	All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Primary	EP2006 Dose (All Cycles)	All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.

1 to 10 of 93Source ClinicalTrials.gov

See all 93 registered outcomes

Outcomes93

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Chemotherapy Toxicity (%FN Risk)	Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.	The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data. Please refer to baseline characteristics tables as well.	participants	NUMBER
PRIMARY	Cancer Treatment Type - Ever Received During Study	All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days	The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data).	participants	NUMBER
PRIMARY	Fever and Infections Ever During the Study	All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days	Evaluable consists of all patients who received at least one dose of study drug, who had no major protocol violations and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e. ANC or completed CIN/FN data).	participants	NUMBER
PRIMARY	Clinical Events Ever During Study (Frequency Threshold: 5%)	All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days	The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data)	participants	NUMBER
PRIMARY	Type of EP2006 Prophylaxis	All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days	Delayed Primary: EP2006 initiated in cycle 2 or later with no CIN/FN in prior cycle.~True secondary: EP2006 initiated in cycle 2 or later following CIN/FN in prior cycle.	participants	NUMBER
PRIMARY	Type of EP2006 Prophylaxis by Gender	All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days	Evaluable sample by gender	participants	NUMBER
PRIMARY	Type of EP 2006 Prophylaxis by Age Group	All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days	Evaluable sample by age	participants	NUMBER
PRIMARY	Type of EP 2006 Prophylaxis by Tumor Type	All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days	Evaluable sample by tumor type	participants	NUMBER
PRIMARY	Concomitant Antibiotic Prophylaxis	All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days		participants	NUMBER
PRIMARY	EP2006 Dose (All Cycles)	All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days	All cycles from patients in the evaluable sample	cycles	NUMBER

1 to 10 of 93Source ClinicalTrials.gov

See all 93 outcomes

Results by group351

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

Outcome	Group	Category	Value	Units
Chemotherapy Toxicity (%FN Risk)	EP2006	Low (<10%)	154	participants
Chemotherapy Toxicity (%FN Risk)	EP2006	Medium (10-20%)	650	participants
Chemotherapy Toxicity (%FN Risk)	EP2006	High (>20%)	640	participants
Chemotherapy Toxicity (%FN Risk)	EP2006	Missing	3	participants
Cancer Treatment Type - Ever Received During Study	EP2006	Surgery	100	participants
Cancer Treatment Type - Ever Received During Study	EP2006	Radiotherapy	102	participants
Cancer Treatment Type - Ever Received During Study	EP2006	Hormonal therapy	85	participants
Cancer Treatment Type - Ever Received During Study	EP2006	Targeted treatment	89	participants
Cancer Treatment Type - Ever Received During Study	EP2006	Bone marrow transplant	31	participants
Cancer Treatment Type - Ever Received During Study	EP2006	Other (e.g., CAM)	98	participants

1 to 10 of 351Source ClinicalTrials.gov

See all 351 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	EP2006	1,496
Overall Study	COMPLETED	EP2006	828
Overall Study	NOT COMPLETED	EP2006	668

Source ClinicalTrials.gov

Adverse events7

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	Bone pain	Musculoskeletal and connective tissue disorders	EP2006	24	1,496	33
other	Arthralgia	Musculoskeletal and connective tissue disorders	EP2006	12	1,496	21
other	Myalgia	Musculoskeletal and connective tissue disorders	EP2006	9	1,496	11
serious	Drug hypersensitivity	Immune system disorders	EP2006	1	1,496	1
serious	Vulvul abscess	Infections and infestations	EP2006	1	1,496	1
serious	Bone pain	Musculoskeletal and connective tissue disorders	EP2006	1	1,496	1
serious	Loss of consciousness	Nervous system disorders	EP2006	1	1,496	1

Source ClinicalTrials.gov

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	EP2006
Total, other adverse events	EP2006	36	1,496
Total, serious adverse events	EP2006	4	1,496

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons5

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

Comparison	Source
EP2006: Any CIN/FN-related Chemotherapy Disturbance vs EP2006: no CIN/FN-related Chemotherapy Disturbance: Number of Participants With All-cause Mortality by CIN/FN-related Chemotherapy Disturbance	Trial comparisons
EP2006: Primary Prophylaxis vs EP2006: Secondary Prophylaxis: Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Prophylaxis Type	Trial comparisons
EP2006: Any CIN/FN-related Chemotherapy Disturbance vs EP2006: No CIN/FN-related Chemotherapy Disturbance: Number of Participants With Cancer-related Mortality by Any CIN/FN-related Chemotherapy Disturbance	Trial comparisons
EP2006: Any Grade 4 CIN/FN vs EP2006: No Grade 4 CIN/FN: Number of Participants With All-cause Mortality by Any/no Grade 4 CIN and/or FN	Trial comparisons
EP2006: Any Grade 4 CIN/FN vs EP2006: No Grade 4 CIN/FN: Number of Participants With Cancer-related Mortality by Any/no Grade 4 CIN or FN	Trial comparisons

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.

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Read this trial from software.

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

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