Trial Outcomes & Findings for Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim (NCT NCT01516736)

Last Updated: 2017-08-30

Results Overview

Mean duration of severe neutropenia, defined as number of consecutive days with ANC \<0.5 × 10\^9/l (grade 4 neutropenia).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

308 participants

Primary outcome timeframe

21 days (Cycle 1 of chemotherapy treatment)

Results posted on

2017-08-30

Participant Flow

Participant milestones

Participant milestones
Measure	LA-EP2006 During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application. LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.	Neulasta® During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application. Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
Overall Study STARTED	155	153
Overall Study COMPLETED	135	140
Overall Study NOT COMPLETED	20	13

Reasons for withdrawal

Reasons for withdrawal
Measure	LA-EP2006 During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application. LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.	Neulasta® During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application. Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
Overall Study Withdrawal by Subject	10	4
Overall Study Adverse Event	4	5
Overall Study Death	3	1
Overall Study Physician Decision	2	1
Overall Study Lack of Efficacy	1	0
Overall Study Protocol Violation	0	1
Overall Study Other (not specified)	0	1

Baseline Characteristics

For 2 patients in the Neulasta treatment group, the date of initial diagnosis was incomplete.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LA-EP2006 n=155 Participants During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application. LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.	Neulasta® n=153 Participants During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application. Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.	Total n=308 Participants Total of all reporting groups
ECOG performance status 0	117 Participants n=155 Participants	110 Participants n=153 Participants	227 Participants n=308 Participants
Age, Continuous	48.8 years STANDARD_DEVIATION 10.50 • n=155 Participants	49.1 years STANDARD_DEVIATION 10.07 • n=153 Participants	48.9 years STANDARD_DEVIATION 10.27 • n=308 Participants
Sex: Female, Male Female	155 Participants n=155 Participants	153 Participants n=153 Participants	308 Participants n=308 Participants
Sex: Female, Male Male	0 Participants n=155 Participants	0 Participants n=153 Participants	0 Participants n=308 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=155 Participants	6 Participants n=153 Participants	16 Participants n=308 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	145 Participants n=155 Participants	147 Participants n=153 Participants	292 Participants n=308 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=155 Participants	0 Participants n=153 Participants	0 Participants n=308 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=155 Participants	0 Participants n=153 Participants	0 Participants n=308 Participants
Race (NIH/OMB) Asian	62 Participants n=155 Participants	58 Participants n=153 Participants	120 Participants n=308 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=155 Participants	0 Participants n=153 Participants	0 Participants n=308 Participants
Race (NIH/OMB) Black or African American	1 Participants n=155 Participants	2 Participants n=153 Participants	3 Participants n=308 Participants
Race (NIH/OMB) White	90 Participants n=155 Participants	93 Participants n=153 Participants	183 Participants n=308 Participants
Race (NIH/OMB) More than one race	2 Participants n=155 Participants	0 Participants n=153 Participants	2 Participants n=308 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=155 Participants	0 Participants n=153 Participants	0 Participants n=308 Participants
BMI	26.56 kg/m^2 STANDARD_DEVIATION 5.771 • n=155 Participants	26.49 kg/m^2 STANDARD_DEVIATION 5.126 • n=153 Participants	26.53 kg/m^2 STANDARD_DEVIATION 5.450 • n=308 Participants
Time since diagnosis	1.28 months n=155 Participants • For 2 patients in the Neulasta treatment group, the date of initial diagnosis was incomplete.	1.28 months n=151 Participants • For 2 patients in the Neulasta treatment group, the date of initial diagnosis was incomplete.	1.28 months n=306 Participants • For 2 patients in the Neulasta treatment group, the date of initial diagnosis was incomplete.
Disease stage I	7 Participants n=155 Participants	13 Participants n=153 Participants	20 Participants n=308 Participants
Disease stage II	70 Participants n=155 Participants	61 Participants n=153 Participants	131 Participants n=308 Participants
Disease stage III	78 Participants n=155 Participants	78 Participants n=153 Participants	156 Participants n=308 Participants
Disease stage IV	0 Participants n=155 Participants	1 Participants n=153 Participants	1 Participants n=308 Participants
Previous breast cancer surgery	154 Participants n=155 Participants	152 Participants n=153 Participants	306 Participants n=308 Participants
Previous radiotherapy	2 Participants n=155 Participants	1 Participants n=153 Participants	3 Participants n=308 Participants
ECOG performance status 1	36 Participants n=155 Participants	43 Participants n=153 Participants	79 Participants n=308 Participants
ECOG performance status 2	2 Participants n=155 Participants	0 Participants n=153 Participants	2 Participants n=308 Participants

PRIMARY outcome

Timeframe: 21 days (Cycle 1 of chemotherapy treatment)

Population: Missing patients in FAS set due to blind data review meeting decision (no ANC profiles available). FAS set = full analysis set; PP set = per protocol set

Mean duration of severe neutropenia, defined as number of consecutive days with ANC \<0.5 × 10\^9/l (grade 4 neutropenia).

Outcome measures

Outcome measures
Measure	LA-EP2006 n=155 Participants During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application. LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.	Neulasta® n=153 Participants During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application. Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy FAS	1.36 days Standard Deviation 1.133	1.19 days Standard Deviation 0.984
Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy PP	1.34 days Standard Deviation 1.141	1.19 days Standard Deviation 0.991

SECONDARY outcome

Timeframe: across all cycles (18 weeks)

Population: FAS set = full analysis set

FN was defined as oral temperature ≥ 38.3°C while having an absolute neutrophil count (ANC) \< 0.5 × 10\^9 cells/L. Serious treatment-emergent adverse events (TEAEs) were reconciled with the fever and ANC results recorded in the patient diary and CRF and therefore only the serious TEAEs of FN ("febrile neutropenia", "neutropenic sepsis") were taken into account.

Outcome measures

Outcome measures
Measure	LA-EP2006 n=155 Participants During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application. LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.	Neulasta® n=153 Participants During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application. Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
Incidence of Febrile Neutropenia (FN) Cycle 5	0 Participants	1 Participants
Incidence of Febrile Neutropenia (FN) Cycle 6	2 Participants	1 Participants
Incidence of Febrile Neutropenia (FN) All cycles (at least on incidence)	16 Participants	20 Participants
Incidence of Febrile Neutropenia (FN) Cycle 1	12 Participants	15 Participants
Incidence of Febrile Neutropenia (FN) Cycle 2	0 Participants	3 Participants
Incidence of Febrile Neutropenia (FN) Cycle 3	3 Participants	1 Participants
Incidence of Febrile Neutropenia (FN) Cycle 4	2 Participants	1 Participants

SECONDARY outcome

Timeframe: across al cycles (18 weeks)

Population: Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set

Fever was defined as an oral body temperature of ≥ 38.3°C. Fever episodes were described by maximum oral temperature and the number of patients who had fever at least once.

Outcome measures

Outcome measures
Measure	LA-EP2006 n=155 Participants During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application. LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.	Neulasta® n=153 Participants During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application. Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles Cycle 1	13 Participants	17 Participants
Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles Cycle 2	8 Participants	6 Participants
Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles Cycle 3	4 Participants	7 Participants
Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles Cycle 4	5 Participants	10 Participants
Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles Cycle 5	3 Participants	3 Participants
Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles Cycle 6	5 Participants	4 Participants
Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles Overall	32 Participants	35 Participants

SECONDARY outcome

Timeframe: Cycle 1 (3 weeks)

Population: FAS set = full analysis set

The depth of ANC nadir was defined as the patient's lowest ANC (10\^9 cells/L) in Cycle 1.

Outcome measures

Outcome measures
Measure	LA-EP2006 n=152 Participants During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application. LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.	Neulasta® n=149 Participants During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application. Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
Depth of ANC Nadir in Cycle 1	0.490 10^9 cells/L Standard Deviation 0.7205	0.444 10^9 cells/L Standard Deviation 0.5684

SECONDARY outcome

Timeframe: Cycle 1 (3 weeks)

Population: FAS set = full analysis set

Numbers of patients with ANC nadir based per day during Cycle 1 are given.

Outcome measures

Outcome measures
Measure	LA-EP2006 n=155 Participants During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application. LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.	Neulasta® n=153 Participants During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application. Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
Number of Patients With ANC Nadir Per Day in Cycle 1 Days 1-5	1 Participants	0 Participants
Number of Patients With ANC Nadir Per Day in Cycle 1 Day 6	9 Participants	8 Participants
Number of Patients With ANC Nadir Per Day in Cycle 1 Day 7	117 Participants	109 Participants
Number of Patients With ANC Nadir Per Day in Cycle 1 Day 8	20 Participants	30 Participants
Number of Patients With ANC Nadir Per Day in Cycle 1 Day 9	3 Participants	2 Participants
Number of Patients With ANC Nadir Per Day in Cycle 1 Days 10-15	2 Participants	0 Participants
Number of Patients With ANC Nadir Per Day in Cycle 1 not definable	3 Participants	4 Participants

SECONDARY outcome

Timeframe: across Cycle 1 (3 weeks)

Population: FAS set = full analysis set

Time to absolute neutrophil count (ANC) recovery was defined as the time in days from ANC nadir until the patient's ANC had increased to ≥ 2 × 10\^9 cells/L after the nadir in Cycle 1.

Outcome measures

Outcome measures
Measure	LA-EP2006 n=155 Participants During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application. LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.	Neulasta® n=153 Participants During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application. Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
Time to ANC Recovery in Days in Cycle 1	2.11 days Standard Deviation 0.889	2.04 days Standard Deviation 0.951

SECONDARY outcome

Timeframe: across all cycles (18 weeks)

Population: Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set

The number of patients with infections was recorded for each cycle and across all cycles. Infections were identified by the AE documentation page selecting all events coded with System Organ Class "Infections and Infestations".

Outcome measures

Outcome measures
Measure	LA-EP2006 n=155 Participants During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application. LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.	Neulasta® n=153 Participants During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application. Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
Frequency of Infections by Cycle and Across All Cycles Cycle 1	10 Participants	14 Participants
Frequency of Infections by Cycle and Across All Cycles Cycle 2	5 Participants	3 Participants
Frequency of Infections by Cycle and Across All Cycles Cycle 3	2 Participants	5 Participants
Frequency of Infections by Cycle and Across All Cycles Cycle 4	4 Participants	5 Participants
Frequency of Infections by Cycle and Across All Cycles Cycle 5	2 Participants	6 Participants
Frequency of Infections by Cycle and Across All Cycles Cycle 6	5 Participants	5 Participants
Frequency of Infections by Cycle and Across All Cycles Overall	26 Participants	32 Participants

SECONDARY outcome

Timeframe: Study course (19 weeks)

Population: FAS set = full analysis set

Number of patients with death due to infections

Outcome measures

Outcome measures
Measure	LA-EP2006 n=155 Participants During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application. LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.	Neulasta® n=153 Participants During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application. Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
Mortality Due to Infection Yes	0 Participants	0 Participants
Mortality Due to Infection No	155 Participants	153 Participants

Adverse Events

LA-EP2006

Serious events: 29 serious events

Other events: 147 other events

Deaths: 3 deaths

Neulasta®

Serious events: 32 serious events

Other events: 144 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Strategic Planning, Biopharmaceutical Clinical Development

Sandoz

Phone: +49 (0) 8024 476 - 0

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	LA-EP2006 n=155 participants at risk During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application. LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.	Neulasta® n=153 participants at risk During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application. Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
Gastrointestinal disorders Gastrointestinal disorders	71.6% 111/155 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used	65.4% 100/153 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used
General disorders General disorders and administration site conditions	60.0% 93/155 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used	58.8% 90/153 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used
Blood and lymphatic system disorders Blood and lymphatic system disorders	49.7% 77/155 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used	47.1% 72/153 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	51.0% 79/155 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used	46.4% 71/153 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	29.0% 45/155 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used	26.1% 40/153 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used
Nervous system disorders Nervous system disorders	20.6% 32/155 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used	16.3% 25/153 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used
Infections and infestations Infections and infestations	15.5% 24/155 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used	17.6% 27/153 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	13.5% 21/155 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used	11.8% 18/153 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used
Metabolism and nutrition disorders Metabolism and nutrition disorders	9.0% 14/155 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used	13.7% 21/153 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used
Investigations Investigations	11.0% 17/155 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used	9.2% 14/153 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used
Vascular disorders Vascular disorders	9.0% 14/155 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used	5.2% 8/153 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used
Reproductive system and breast disorders Reproductive system and breast disorders	6.5% 10/155 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used	3.3% 5/153 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used
Eye disorders Eye disorders	5.2% 8/155 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used	3.9% 6/153 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	2.6% 4/155 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used	3.3% 5/153 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used
Renal and urinary disorders Renal and urinary disorders	0.65% 1/155 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used	3.3% 5/153 • Patients were followed for a 4-week safety period from the last administration of pegfilgrastim. Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used