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.

Primary analysis set

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).

Primary analysis set

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).

Primary analysis set

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 who received at least 1 cycle of chemotherapy in which no pegfilgrastim prophylaxis was administered, but another G-CSF was administered.

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 who received at least 1 cycle of chemotherapy in which no G-CSF prophylaxis was administered.

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.

All cycles of chemotherapy for participants in the primary analysis set

A cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.

All cycles of chemotherapy for participants in the primary analysis set

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 who received at least 1 cycle of chemotherapy in which no pegfilgrastim prophylaxis was administered, but another G-CSF was administered.

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 who received at least 1 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.

primary analysis set

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.

All FN events observed for participants in the primary analysis set

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 who received at least 1 cycle of chemotherapy in which no G-CSF prophylaxis was administered.

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 who received at least 1 cycle of chemotherapy in which no G-CSF prophylaxis was administered

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 of chemotherapy for participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered.

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 of chemotherapy for participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered, in which no G-CSF prophylaxis was administered.

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.

Primary analysis set

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 who received pegfilgrastim across all cycles, administered 1- 3 days after the end of cytotoxic chemotherapy in each cycle.