FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of pegfilgrastim support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.

FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.

FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any other G-CSF starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.

FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.

FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with pegfilgrastim is defined as participants who started pegfilgrastim treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.

FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any daily G-CSF is defined as participants who started daily G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.

FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any other G-CSF is defined as participants who started other G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.

The average number of days of daily G-CSF use per cycle was calculated across all administered cycles.

The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.

The average number of days of daily G-CSF use per cycle was calculated across all administered cycles.

The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.

A dose delay is defined as a delay of more than 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of participants with delays in chemotherapy administration are summarized by the length of delay (> 3 days, > 5 days, and > 7 days) across cycles 2 through 8.

A dose delay is defined as a delay of > 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of cycles delayed are summarized by the length of delay (> 3 days, > 5 days, and > 7 days) across cycles 2 through 8.

A participant is considered to have a dose reduction in a given cycle if there was a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.

A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.

A dose delay is defined as a delay of > 3 days in the start of chemotherapy measured since the start of the previous cycle.

A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.

Number of participants with systemic anti-infective use, including antibiotics, anti-fungal and virostatic for prophylaxis or treatment.

Unplanned hospitalizations included only those which involved an overnight stay and occurred in cycles 1 to 8.

The number of participants experiencing treatment related grade 3 and 4 hematological toxicities during cycles 1 to 8. Participants experiencing both Grade 3 and Grade 4 toxicities are reported under Grade 4 only (maximum toxicity). Toxicity grades for hematology data are defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0: Absolute neutrophil count (ANC) - Grade 3: < 1.0 - 0.5 x 10^9/L; ANC - Grade 4: < 0.5 x 10^9/L; White blood cells (WBC) - Grade 3: < 2.0 - 1.0 x 10^9/L; WBC - Grade 4: < 1.0 x 10^9/L; Hemoglobin - Grade 3: < 8.0 - 6.5 g/dL; Hemoglobin - Grade 4: < 6.5 g/dL; Platelets - Grade 3: < 50 - 25 x 10^9/L; Platelets - Grade 4: < 25 x 10^9/L.

Time to disease progression was calculated from cycle 1 day 1 to a date at which disease progression was first recorded. Participants who died due to causes other than disease progression were censored at the date of death. Participants who were alive and whose disease had not progressed at the most recent contact, or who were lost to follow-up, or with missing data, were censored at the date of last contact. Median time to disease progression was estimated from the Kaplan-Meier survival function.

The reason treatment with an ESA was initiated as recorded by the investigator; participants may have more than one reason for initiating treatment.

The average number of clinical visits per month (28 day period) during cycles 1 to 8 and during the period of ESA treatment in cycles 1 to 8.

Kaplan-Meier estimate of the percentage of participants with RBC transfusions from five weeks post initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.

Kaplan-Meier estimate of the percentage of participants in cycles 1 to 8 receiving ESA treatment who achieved a hematopoietic response during the ESA treatment phase, defined as a hemoglobin concentration ≥ 12 g/dL or a ≥ 2 g/dL rise in hemoglobin after starting ESA treatment.

Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 9 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.

Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 10 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.

Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 11 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.

Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 12 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.

Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level from 10 to 12 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.

Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level from 12 to 13 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.

The percentage of participants achieving a hemoglobin level from 10 to 12 g/dL after 9 weeks of ESA treatment.

Number of participants who received transfusions, including platelets, packed red blood cells, whole blood, or other, during cycles 1 to 8.

A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self care, unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.

Episodes of febrile neutropenia (FN) that occurred during prior cancer treatment; 698 participants had received prior treatment.

Anemia symptoms were available for 692 participants at baseline. Participants may have more than one anemia symptom.

Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.

Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.

Participants diagnosed with metastatic breast cancer and receiving chemotherapy.

Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.

Full analysis set

FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants in the No G-CSF use group received no G-CSF prophylaxis or treatment at any time during cycles 1 to 8.

Full analysis set participants who received no prophylaxis or treatment with any G-CSF

FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of Cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.

Full analysis set participants who received primary prophylaxis with pegfilgrastim

FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any daily G-CSF (e.g. filgrastim or lenograstim) starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.

Full analysis set participants who received primary prophylaxis with any daily G-CSF

FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of pegfilgrastim support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.

Full analysis set participants who received secondary prophylaxis with pegfilgrastim

FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.

Full analysis set participants who received secondary prophylaxis with any daily G-CSF

The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.

Full analysis set participants who received primary prophylaxis with pegfilgrastim

The average number of days of daily G-CSF use per cycle was calculated across all administered cycles.

Full analysis set participants who received primary prophylaxis with any daily G-CSF

The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.

Full analysis set participants who received secondary prophylaxis with pegfilgrastim

The average number of days of daily G-CSF use per cycle was calculated across all administered cycles.

Full analysis set participants who received secondary prophylaxis with any daily G-CSF.

FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any other G-CSF starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.

Full analysis set participants who received primary prophylaxis with other G-CSF

FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.

Full analysis set participants who received secondary prophylaxis with other G-CSF

FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with pegfilgrastim is defined as participants who started pegfilgrastim treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.

Full analysis set participants who received treatment with pegfilgrastim

FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any daily G-CSF is defined as participants who started daily G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.

Full analysis set participants who received treatment with any daily G-CSF

FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any other G-CSF is defined as participants who started other G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.

Full analysis set participants who received treatment with any other G-CSF

The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.

Full analysis set participants who received treatment with pegfilgrastim

Full analysis set participants who received treatment with any daily G-CSF

A dose delay is defined as a delay of more than 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of participants with delays in chemotherapy administration are summarized by the length of delay (> 3 days, > 5 days, and > 7 days) across cycles 2 through 8.

Full analysis set participants who received more than 1 cycle of chemotherapy

A dose delay is defined as a delay of > 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of cycles delayed are summarized by the length of delay (> 3 days, > 5 days, and > 7 days) across cycles 2 through 8.

Full analysis set participants who received more than 1 cycle of chemotherapy

A participant is considered to have a dose reduction in a given cycle if there was a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.

Full analysis set participants with actual regimens as planned (17 participants received a different regimen to what was planned and are thus excluded)

A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.

Full analysis set participants with actual regimens as planned (17 participants received a different regimen to what was planned and are thus excluded)

A dose delay is defined as a delay of > 3 days in the start of chemotherapy measured since the start of the previous cycle.

Full analysis set participants who received more than 1 cycle of chemotherapy and had > 3 days delay in one or more cycles

A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.

Full analysis set participants with actual regimens as planned and with ≥ 15% chemotherapy dose reduction in any cycle.

Number of participants with systemic anti-infective use, including antibiotics, anti-fungal and virostatic for prophylaxis or treatment.

Full analysis set

Unplanned hospitalizations included only those which involved an overnight stay and occurred in cycles 1 to 8.

Full analysis set

Full analysis set

The number of participants experiencing treatment related grade 3 and 4 hematological toxicities during cycles 1 to 8. Participants experiencing both Grade 3 and Grade 4 toxicities are reported under Grade 4 only (maximum toxicity). Toxicity grades for hematology data are defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0: Absolute neutrophil count (ANC) - Grade 3: < 1.0 - 0.5 x 10^9/L; ANC - Grade 4: < 0.5 x 10^9/L; White blood cells (WBC) - Grade 3: < 2.0 - 1.0 x 10^9/L; WBC - Grade 4: < 1.0 x 10^9/L; Hemoglobin - Grade 3: < 8.0 - 6.5 g/dL; Hemoglobin - Grade 4: < 6.5 g/dL; Platelets - Grade 3: < 50 - 25 x 10^9/L; Platelets - Grade 4: < 25 x 10^9/L.

Full analysis set

Time to disease progression was calculated from cycle 1 day 1 to a date at which disease progression was first recorded. Participants who died due to causes other than disease progression were censored at the date of death. Participants who were alive and whose disease had not progressed at the most recent contact, or who were lost to follow-up, or with missing data, were censored at the date of last contact. Median time to disease progression was estimated from the Kaplan-Meier survival function.

Full analysis set

Participants who received treatment with an ESA

The reason treatment with an ESA was initiated as recorded by the investigator; participants may have more than one reason for initiating treatment.

Participants who received treatment with an ESA

Participants who received treatment with an ESA

The average number of clinical visits per month (28 day period) during cycles 1 to 8 and during the period of ESA treatment in cycles 1 to 8.