An observational study in Chemotherapy-induced Febrile Neutropenia, sponsored by Amgen. Completed at 75 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-23.
Sponsored by Amgen · Observational
To estimate the incidence of febrile neutropenia in patients with breast cancer and non-Hodgkin's lymphoma receiving high (> 20%) FN-risk chemotherapy and pegfilgrastim primary prophylaxis.
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This study's enrollment of 943 is above the median of 150 across 159 observational studies indexed under Lymphoma, Non-Hodgkin.
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Patients with NHL or breast cancer who have initiated treatment with a permitted standard-dose chemotherapy regimen that has a high FN risk (> 20%) per published studies or international guidelines, and who started pegfilgrastim in Cycle 1
Exclusion Criteria:
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
Percentage of Participants With Febrile Neutropenia
Febrile neutropenia (FN) was defined as an absolute neutrophil count (ANC) of \< 0.5 x 10\^9/L, or \< 1.0 x 10\^9/L predicted to fall below 0.5 x 10\^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Participants Who Discontinued Pegfilgrastim Prophylaxis
Participants who discontinued pegfilgrastim prophylaxis was defined as participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other granulocyte colony-stimulating factor (G-CSF) prophylaxis was administered. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles. Discontinuation was categorized as either temporary (participant received pegfilgrastim prophylaxis in at least one subsequent cycle) or permanent (participant had at least one cycle of chemotherapy following the cycle in which no pegfilgrastim prophylaxis was administered, and other G-CSF prophylaxis (i.e. not pegfilgrastim) was administered in all subsequent cycles, OR participant did not receive pegfilgrastim prophylaxis in the last cycle of chemotherapy, and other G-CSF prophylaxis was administered).
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Participants Who Discontinued G-CSF Prophylaxis
Participants who discontinued G-CSF prophylaxis was defined as participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered. Discontinuation was categorized as either temporary (participant received G-CSF prophylaxis in at least one subsequent cycle) or permanent (participant had at least one cycle of chemotherapy following the cycle in which no G-CSF prophylaxis was administered, and no G-CSF prophylaxis was administered in any subsequent cycle, OR participant did not receive G-CSF prophylaxis in the last cycle of chemotherapy).
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis
Participants who discontinued pegfilgrastim prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles. Data includes both temporary and permanent pegfilgrastim discontinuation.
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Characteristics of Participants Who Discontinued G-CSF Prophylaxis
Participants who discontinued G-CSF prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered. Data includes both temporary and permanent discontinuation of G-CSF prophylaxis.
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Cycles With No Pegfilgrastim Prophylaxis
A cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle.
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Cycles With no G-CSF Prophylaxis
A cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Reasons for Discontinuation of Pegfilgrastim Prophylaxis
Participants who discontinued pegfilgrastim prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles. Data includes both temporary and permanent pegfilgrastim discontinuation.
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Reasons for Discontinuation of G-CSF Prophylaxis
Participants who discontinued G-CSF prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered. Data includes both temporary and permanent discontinuation of G-CSF prophylaxis. Participants may have more than 1 discontinuation reason.
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Percentage of Participants Who Experienced Complications of Febrile Neutropenia
Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Febrile Neutropenia Events That Occurred During Cycles With No G-CSF Prophylaxis
The number of febrile neutropenia events that occurred during a cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of \< 0.5 x 10\^9/L, or \< 1.0 x 10\^9/L predicted to fall below 0.5 x 10\^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Participants Who Experienced Febrile Neutropenia During Cycles With No G-CSF Prophylaxis
The number of participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered who experienced febrile neutropenia during a cycle of chemotherapy in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of \< 0.5 x 10\^9/L, or \< 1.0 x 10\^9/L predicted to fall below 0.5 x 10\^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Participants Who Experienced Complications of Febrile Neutropenia During Cycles With No G-CSF Prophylaxis
The number of participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered who experienced complications of febrile neutropenia during a cycle of chemotherapy in which no G-CSF prophylaxis was administered. Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Cycles With No G-CSF Prophylaxis in Which Febrile Neutropenia Events Occurred
The number of chemotherapy cycles during which an event of febrile neutropenia occurred in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of \< 0.5 x 10\^9/L, or \< 1.0 x 10\^9/L predicted to fall below 0.5 x 10\^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Cycles With No G-CSF Prophylaxis in Which Complications of Febrile Neutropenia Occurred
The number of chemotherapy cycles during which complications of febrile neutropenia occurred in which no G-CSF prophylaxis was administered. Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Participants Who Permanently Switched From Pegfilgrastim Prophylaxis to Other G-CSF Prophylaxis
The number of participants who received pegfilgrastim prophylaxis from cycle 1 until a cycle when other G-CSF prophylaxis was administered, and this G-CSF or a different G-CSF agent (not pegfilgrastim) was received as prophylaxis at each remaining cycle of the chemotherapy course.
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis
On-schedule pegfilgrastim primary prophylaxis was defined as participants who received pegfilgrastim in cycle 1 and continued to receive pegfilgrastim across all cycles, administered 1-3 days after the end of cytotoxic chemotherapy in each cycle.
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
The study was conducted at 66 centers in Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Poland, and Romania. The first participant enrolled on 18 July 2014 and the last participant enrolled on 28 April 2016.
| Milestone | Chemotherapy + Pegfilgrastim |
|---|---|
| Started | 943 |
| Primary analysis set | 844 |
| Completed | 814 |
| Not completed | 129 |
| Withdrew: Withdrawal by subject | 7 |
| Withdrew: Lost to follow-up | 10 |
| Withdrew: Death | 13 |
| Withdrew: Protocol-specified criteria | 99 |
Febrile neutropenia (FN) was defined as an absolute neutrophil count (ANC) of \< 0.5 x 10\^9/L, or \< 1.0 x 10\^9/L predicted to fall below 0.5 x 10\^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
| percentage of participants | Chemotherapy + Pegfilgrastim |
|---|---|
| Overall | 3.3 (2.3 to 4.8) |
| Cycle 1 | 1.9 (1.2 to 3.1) |
| Cycle 2 | 0.4 (0.1 to 1.1) |
| Cycle 3 | 0.5 (0.2 to 1.3) |
| Cycle 4 | 0.5 (0.2 to 1.3) |
| Cycle 5 | 0.3 (0.1 to 1.0) |
| Cycle 6 | 0.3 (0.1 to 1.1) |
| Cycle 7 | 0.0 (0.0 to 1.6) |
| Cycle 8 | 0.0 (0.0 to 1.7) |
Participants who discontinued pegfilgrastim prophylaxis was defined as participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other granulocyte colony-stimulating factor (G-CSF) prophylaxis was administered. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles. Discontinuation was categorized as either temporary (participant received pegfilgrastim prophylaxis in at least one subsequent cycle) or permanent (participant had at least one cycle of chemotherapy following the cycle in which no pegfilgrastim prophylaxis was administered, and other G-CSF prophylaxis (i.e. not pegfilgrastim) was administered in all subsequent cycles, OR participant did not receive pegfilgrastim prophylaxis in the last cycle of chemotherapy, and other G-CSF prophylaxis was administered).
| participants | Chemotherapy + Pegfilgrastim |
|---|---|
| Discontinuation of pegfilgrastim prophylaxis | 26 |
| Temporary discontinuation | 4 |
| Permanent discontinuation | 22 |
Participants who discontinued G-CSF prophylaxis was defined as participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered. Discontinuation was categorized as either temporary (participant received G-CSF prophylaxis in at least one subsequent cycle) or permanent (participant had at least one cycle of chemotherapy following the cycle in which no G-CSF prophylaxis was administered, and no G-CSF prophylaxis was administered in any subsequent cycle, OR participant did not receive G-CSF prophylaxis in the last cycle of chemotherapy).
| participants | Chemotherapy + Pegfilgrastim |
|---|---|
| Discontinuation of G-CSF prophylaxis | 44 |
| Temporary discontinuation | 9 |
| Permanent discontinuation | 35 |
Participants who discontinued pegfilgrastim prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles. Data includes both temporary and permanent pegfilgrastim discontinuation.
| participants | Chemotherapy + Pegfilgrastim |
|---|---|
| Male | 6 |
| Female | 20 |
| Race: Black | 0 |
| Race: White | 15 |
| Race: Missing | 11 |
| Age < 65 years | 15 |
| Age ≥ 65 years | 11 |
| Age ≥ 75 years | 1 |
| Tumor type: NHL | 15 |
| Tumor type: Breast cancer | 11 |
Participants who discontinued G-CSF prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered. Data includes both temporary and permanent discontinuation of G-CSF prophylaxis.
| participants | Chemotherapy + Pegfilgrastim |
|---|---|
| Male | 8 |
| Female | 36 |
| Race: Black | 0 |
| Race: White | 36 |
| Race: Missing | 8 |
| Age < 65 years | 26 |
| Age ≥ 65 years | 18 |
| Age ≥ 75 years | 2 |
| Tumor type: NHL | 13 |
| Tumor type: Breast cancer | 31 |
A cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle.
| cycles | Chemotherapy + Pegfilgrastim |
|---|---|
| Number of Cycles With No Pegfilgrastim Prophylaxis | 56 |
A cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.
| cycles | Chemotherapy + Pegfilgrastim |
|---|---|
| Number of Cycles With no G-CSF Prophylaxis | 105 |
Participants who discontinued pegfilgrastim prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles. Data includes both temporary and permanent pegfilgrastim discontinuation.
| Participants | Chemotherapy + Pegfilgrastim |
|---|---|
| Daily G-CSF preferred to once-per-cycle G-CSF | 14 |
| Cost | 1 |
| Following protocol of hospital or country/region | 2 |
| Adverse reaction to G-CSF | 6 |
| Other | 3 |
Participants who discontinued G-CSF prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered. Data includes both temporary and permanent discontinuation of G-CSF prophylaxis. Participants may have more than 1 discontinuation reason.
| participants | Chemotherapy + Pegfilgrastim |
|---|---|
| Chemotherapy dose intensity reduced | 9 |
| Patient no longer considered at high risk of FN | 14 |
| Cost | 3 |
| Following protocol of hospital or country/region | 2 |
| Adverse reaction to G-CSF | 3 |
| Other | 22 |
| Missing | 2 |
Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.
| percentage of participants | Chemotherapy + Pegfilgrastim |
|---|---|
| Percentage of Participants Who Experienced Complications of Febrile Neutropenia | 6.8 (5.2 to 8.7) |
The number of febrile neutropenia events that occurred during a cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of \< 0.5 x 10\^9/L, or \< 1.0 x 10\^9/L predicted to fall below 0.5 x 10\^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
| febrile neutropenia events | Chemotherapy + Pegfilgrastim |
|---|---|
| Number of Febrile Neutropenia Events That Occurred During Cycles With No G-CSF Prophylaxis | 2 |
The number of participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered who experienced febrile neutropenia during a cycle of chemotherapy in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of \< 0.5 x 10\^9/L, or \< 1.0 x 10\^9/L predicted to fall below 0.5 x 10\^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
| participants | Chemotherapy + Pegfilgrastim |
|---|---|
| Number of Participants Who Experienced Febrile Neutropenia During Cycles With No G-CSF Prophylaxis | 2 |
The number of participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered who experienced complications of febrile neutropenia during a cycle of chemotherapy in which no G-CSF prophylaxis was administered. Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.
| participants | Chemotherapy + Pegfilgrastim |
|---|---|
| Number of Participants Who Experienced Complications of Febrile Neutropenia During Cycles With No G-CSF Prophylaxis | 3 |
The number of chemotherapy cycles during which an event of febrile neutropenia occurred in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of \< 0.5 x 10\^9/L, or \< 1.0 x 10\^9/L predicted to fall below 0.5 x 10\^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
| cycles | Chemotherapy + Pegfilgrastim |
|---|---|
| Number of Cycles With No G-CSF Prophylaxis in Which Febrile Neutropenia Events Occurred | 2 |
The number of chemotherapy cycles during which complications of febrile neutropenia occurred in which no G-CSF prophylaxis was administered. Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.
| cycles | Chemotherapy + Pegfilgrastim |
|---|---|
| Number of Cycles With No G-CSF Prophylaxis in Which Complications of Febrile Neutropenia Occurred | 3 |
The number of participants who received pegfilgrastim prophylaxis from cycle 1 until a cycle when other G-CSF prophylaxis was administered, and this G-CSF or a different G-CSF agent (not pegfilgrastim) was received as prophylaxis at each remaining cycle of the chemotherapy course.
| participants | Chemotherapy + Pegfilgrastim |
|---|---|
| Number of Participants Who Permanently Switched From Pegfilgrastim Prophylaxis to Other G-CSF Prophylaxis | 22 |
On-schedule pegfilgrastim primary prophylaxis was defined as participants who received pegfilgrastim in cycle 1 and continued to receive pegfilgrastim across all cycles, administered 1-3 days after the end of cytotoxic chemotherapy in each cycle.
| participants | Chemotherapy + Pegfilgrastim |
|---|---|
| Male | 72 |
| Female | 611 |
| Race: White | 546 |
| Race: Black or African American | 2 |
| Race: Other | 1 |
| Race: Missing | 134 |
| Age < 65 years | 464 |
| Age ≥ 65 years | 219 |
| Age ≥ 75 years | 38 |
| Tumor type: NHL | 112 |
| Tumor type: Breast cancer | 571 |
Collected over Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.. Non-serious events are listed at a 1.00% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chemotherapy + Pegfilgrastim | — | 5/844 (0.6%) | 11/844 (1.3%) |
| Event | Chemotherapy + Pegfilgrastim |
|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 3/844 |
| Abdominal painGastrointestinal disorders | 2/844 |
| Back painMusculoskeletal and connective tissue disorders | 1/844 |
| Event | Chemotherapy + Pegfilgrastim |
|---|---|
| Bone painMusculoskeletal and connective tissue disorders | 11/844 |
Primary Analysis Set
| Age, Continuous(years) | Chemotherapy + Pegfilgrastim |
|---|---|
| Mean | 57.2 ± 12.2 |
| Age, Customized(Participants) | Chemotherapy + Pegfilgrastim |
|---|---|
| < 65 years | 563 |
| ≥ 65 years | 281 |
| Sex: Female, Male(Participants) | Chemotherapy + Pegfilgrastim |
|---|---|
| Female | 723 |
| Male | 121 |
| Race/Ethnicity, Customized(Participants) | Chemotherapy + Pegfilgrastim |
|---|---|
| Black | 4 |
| White | 673 |
| Other | 1 |
| Missing | 166 |
| Tumor Type(Participants) | Chemotherapy + Pegfilgrastim |
|---|---|
| Non-Hodgkin's lymphoma (NHL) | 190 |
| Breast cancer | 654 |
| Baseline Comorbidities(participants) | Chemotherapy + Pegfilgrastim |
|---|---|
| Liver disease | 18 |
| Cardiovascular disease | 211 |
| Diabetes mellitus | 75 |
| COPD/Pulmonary disease | 41 |
| Renal disease/impaired clearance | 16 |
| Current infection | 8 |
| Open wound | 3 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status(Participants) | Chemotherapy + Pegfilgrastim |
|---|---|
| 0 (Fully active) | 645 |
| 1 (Restrictive but ambulatory) | 129 |
| 2 (Ambulatory but unable to work) | 14 |
| 3 (Limited self-care) | 6 |
| 4 (Disabled, confined to bed/chair) | 1 |
| Missing | 49 |
| History of Febrile Neutropenia(Participants) | Chemotherapy + Pegfilgrastim |
|---|---|
| Yes | 5 |
| No | 839 |
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