Trial Outcomes & Findings for A Study of Neutropenia and Anemia Management in Patients With Solid Tumors Receiving Myelotoxic Chemotherapy (NCT NCT00883181)

Results Overview

Febrile neutropenia 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.

Recruitment status

COMPLETED

Target enrollment

1370 participants

Primary outcome timeframe

Cycles 1 - 8 (approximately 24 weeks)

Results posted on

2017-03-15

Participant Flow

A total of 1370 patients were enrolled at 87 sites in Europe, 5 sites in Canada, and 10 sites in Australia from December 2007 to October 2009. Of these, 1347 participants were included in the full analysis set (FAS) consisting of all enrolled patients who met protocol defined eligibility criteria and started at least 1 cycle of chemotherapy.

Eligible patients were enrolled sequentially. Upon completion of all planned chemotherapy cycles, or following cessation of chemotherapy for any reason, patients were followed-up annually for 5 years or until disease progression or death.

Participant milestones

Participant milestones
Measure	Full Analysis Set Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
Overall Study STARTED	1347
Overall Study COMPLETED	1069
Overall Study NOT COMPLETED	278

Reasons for withdrawal

Reasons for withdrawal
Measure	Full Analysis Set Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
Overall Study Hematological Adverse Event	26
Overall Study Non-hematological Adverse Event	55
Overall Study Disease Progression	94
Overall Study Administrative Reason	24
Overall Study Withdrawal by Subject	4
Overall Study Death	31
Overall Study Other	38
Overall Study Protocol Deviation	3
Overall Study Noncompliance	3

Baseline Characteristics

A Study of Neutropenia and Anemia Management in Patients With Solid Tumors Receiving Myelotoxic Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Full Analysis Set n=1347 Participants Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
Age, Continuous	56.4 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	1072 Participants n=5 Participants
Sex: Female, Male Male	275 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	1324 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	4 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 participants n=5 Participants
Race/Ethnicity, Customized Asian	4 participants n=5 Participants
Race/Ethnicity, Customized Other	4 participants n=5 Participants
Race/Ethnicity, Customized Not Applicable	8 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - Normal Activity	874 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1 - Symptoms but Ambulatory	346 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 2 - Confined to Bed ≤ 50% of Time	99 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 3 - Confined to Bed ≥ 50% of Time	9 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 4 - 100% Bedridden	0 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Missing	19 participants n=5 Participants
Tumor Type Ovarian cancer	157 participants n=5 Participants
Tumor Type Non-small cell lung cancer (NSCLC)	224 participants n=5 Participants
Tumor Type Small cell lung cancer (SCLC)	137 participants n=5 Participants
Tumor Type Breast cancer	829 participants n=5 Participants
Prior Treatment None	647 participants n=5 Participants
Prior Treatment Chemotherapy only	88 participants n=5 Participants
Prior Treatment Radiotherapy only	19 participants n=5 Participants
Prior Treatment Chemotherapy and radiotherapy	62 participants n=5 Participants
Prior Treatment Surgery	449 participants n=5 Participants
Prior Treatment Other	80 participants n=5 Participants
Prior Treatment Missing	2 participants n=5 Participants
Prior Febrile Neutropenia Episodes Any prior FN episodes	35 participants n=5 Participants
Prior Febrile Neutropenia Episodes No prior FN episodes	213 participants n=5 Participants
Prior Febrile Neutropenia Episodes Missing	450 participants n=5 Participants
Hemoglobin Level < 11 g/dL	175 participants n=5 Participants
Hemoglobin Level ≥ 11 g/dL	1091 participants n=5 Participants
Hemoglobin Level Missing	81 participants n=5 Participants
Anemia Symptoms Fatigue/tiredness	197 participants n=5 Participants
Anemia Symptoms Pallor/Pale skin	86 participants n=5 Participants
Anemia Symptoms Headache	53 participants n=5 Participants
Anemia Symptoms Dyspnea	101 participants n=5 Participants
Anemia Symptoms Tachycardia and/or palpitations	48 participants n=5 Participants
Anemia Symptoms Dizziness and/or vertigo	49 participants n=5 Participants
Anemia Symptoms Irritability	66 participants n=5 Participants
Anemia Symptoms Depression	113 participants n=5 Participants
Anemia Symptoms Nausea	38 participants n=5 Participants
Anemia Symptoms Anorexia	65 participants n=5 Participants
Anemia Symptoms Impaired cognitive function	17 participants n=5 Participants
Anemia Symptoms Impaired immune system	12 participants n=5 Participants
Anemia Symptoms Metabolic dysfunction	32 participants n=5 Participants
Anemia Symptoms Sexual dysfunction	54 participants n=5 Participants

PRIMARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: Full analysis set; Note: One participant with breast cancer had disease stage missing.

Febrile neutropenia 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.

Outcome measures

Outcome measures
Measure	Ovarian n=157 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=224 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=137 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=738 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=90 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=829 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants With Febrile Neutropenia (FN)	8 percentage of participants Interval 4.0 to 13.0	8 percentage of participants Interval 5.0 to 12.0	15 percentage of participants Interval 10.0 to 21.0	9 percentage of participants Interval 7.0 to 11.0	11 percentage of participants Interval 6.0 to 19.0	9 percentage of participants Interval 7.0 to 11.0

PRIMARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: 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. 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.

Outcome measures

Outcome measures
Measure	Ovarian n=82 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=120 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=56 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=147 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=28 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=175 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia	4 percentage of participants Interval 1.0 to 10.0	3 percentage of participants Interval 1.0 to 7.0	5 percentage of participants Interval 2.0 to 15.0	1 percentage of participants Interval 1.0 to 4.0	0 percentage of participants Not calculated when n=0	1 percentage of participants Interval 1.0 to 3.0

PRIMARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: 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 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.

Outcome measures

Outcome measures
Measure	Ovarian n=24 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=22 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=33 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=360 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=32 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=393 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia	0 percentage of participants Not calculated when n=0	0 percentage of participants Not calculated when n=0	21 percentage of participants Interval 11.0 to 38.0	9 percentage of participants Interval 7.0 to 13.0	9 percentage of participants Interval 3.0 to 24.0	9 percentage of participants Interval 7.0 to 13.0

PRIMARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: 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. 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.

Outcome measures

Outcome measures
Measure	Ovarian n=6 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=20 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=11 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=51 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=6 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=57 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia	0 percentage of participants Not calculated when n=0	20 percentage of participants Interval 8.0 to 42.0	9 percentage of participants Interval 2.0 to 38.0	6 percentage of participants Interval 2.0 to 16.0	17 percentage of participants Interval 3.0 to 56.0	7 percentage of participants Interval 3.0 to 17.0

PRIMARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: 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 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.

Outcome measures

Outcome measures
Measure	Ovarian n=11 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=14 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=15 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=92 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=9 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=101 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia	0 percentage of participants Not calculated when n=0	36 percentage of participants Interval 16.0 to 61.0	40 percentage of participants Interval 20.0 to 64.0	14 percentage of participants Interval 8.0 to 23.0	33 percentage of participants Interval 12.0 to 65.0	16 percentage of participants Interval 10.0 to 24.0

PRIMARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: 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. 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.

Outcome measures

Outcome measures
Measure	Ovarian n=15 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=24 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=13 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=64 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=9 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=73 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia	27 percentage of participants Interval 11.0 to 52.0	13 percentage of participants Interval 4.0 to 31.0	15 percentage of participants Interval 4.0 to 42.0	20 percentage of participants Interval 12.0 to 32.0	22 percentage of participants Interval 6.0 to 55.0	21 percentage of participants Interval 13.0 to 31.0

PRIMARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: 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. 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.

Outcome measures

Outcome measures
Measure	Ovarian n=1 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=3 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=6 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=1 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=7 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia	0 percentage of participants Not calculated when n=0	0 percentage of participants Not calculated when n=0	—	17 percentage of participants Interval 3.0 to 56.0	0 percentage of participants Not calculated when n=0	14 percentage of participants Interval 3.0 to 51.0

PRIMARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: 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. 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.

Outcome measures

Outcome measures
Measure	Ovarian n=4 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=3 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=1 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=1 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=2 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants Receiving Secondary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia	25 percentage of participants Interval 5.0 to 70.0	0 percentage of participants Not calculated when n=0	—	0 percentage of participants Not calculated when n=0	0 percentage of participants Not calculated when n=0	0 percentage of participants Not calculated when n=0

PRIMARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: 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 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.

Outcome measures

Outcome measures
Measure	Ovarian n=5 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=2 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=1 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants Receiving Treatment With Pegfilgrastim Who Experienced Febrile Neutropenia	0 percentage of participants Not calculated when n=0	0 percentage of participants Not calculated when n=0	0 percentage of participants Not calculated when n=0	—	—	—

PRIMARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: 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 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.

Outcome measures

Outcome measures
Measure	Ovarian n=9 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=15 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=8 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=17 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=4 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=21 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants Receiving Treatment With Any Daily G-CSF Who Experienced Febrile Neutropenia	44 percentage of participants Interval 19.0 to 73.0	13 percentage of participants Interval 4.0 to 38.0	13 percentage of participants Interval 2.0 to 47.0	12 percentage of participants Interval 3.0 to 34.0	25 percentage of participants Interval 5.0 to 70.0	14 percentage of participants Interval 5.0 to 35.0

PRIMARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: Full analysis set participants who received treatment with any 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 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.

Outcome measures

Outcome measures
Measure	Ovarian Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=1 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants Receiving Treatment With Any Other G-CSF Who Experienced Febrile Neutropenia	—	100 percentage of participants Not calculated when n=100	—	—	—	—

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Ovarian n=157 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=224 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=137 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=738 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=90 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=829 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Number of Participants Who Received G-CSF During Cycles 1 to 8 Primary Prophylaxis - Pegfilgrastim	24 participants	22 participants	33 participants	360 participants	32 participants	393 participants
Number of Participants Who Received G-CSF During Cycles 1 to 8 Primary Prophylaxis - Any Daily G-CSF	6 participants	20 participants	11 participants	51 participants	6 participants	57 participants
Number of Participants Who Received G-CSF During Cycles 1 to 8 Primary Prophylaxis - Other G-CSF	1 participants	3 participants	0 participants	6 participants	1 participants	7 participants
Number of Participants Who Received G-CSF During Cycles 1 to 8 Secondary Prophylaxis - Pegfilgrastim	11 participants	14 participants	15 participants	92 participants	9 participants	101 participants
Number of Participants Who Received G-CSF During Cycles 1 to 8 Secondary Prophylaxis - Any Daily G-CSF	15 participants	24 participants	13 participants	64 participants	9 participants	73 participants
Number of Participants Who Received G-CSF During Cycles 1 to 8 Secondary Prophylaxis - Other G-CSF	4 participants	3 participants	0 participants	1 participants	1 participants	2 participants
Number of Participants Who Received G-CSF During Cycles 1 to 8 Treatment - Pegfilgrastim	5 participants	2 participants	1 participants	0 participants	0 participants	0 participants
Number of Participants Who Received G-CSF During Cycles 1 to 8 Treatment - Any Daily G-CSF	9 participants	15 participants	8 participants	17 participants	4 participants	21 participants
Number of Participants Who Received G-CSF During Cycles 1 to 8 Treatment - Other G-CSF	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants Who Received G-CSF During Cycles 1 to 8 No G-CSF Used	82 participants	120 participants	56 participants	147 participants	28 participants	175 participants

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: Full analysis set participants who received primary prophylaxis with pegfilgrastim

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

Outcome measures

Outcome measures
Measure	Ovarian n=24 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=22 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=33 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=360 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=32 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=393 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Pegfilgrastim	1.00 days Standard Deviation 0.00	1.00 days Standard Deviation 0.00	1.01 days Standard Deviation 0.03 • Interval 11.0 to 38.0	1.00 days Standard Deviation 0.05 • Interval 7.0 to 13.0	1.01 days Standard Deviation 0.03 • Interval 3.0 to 24.0	1.00 days Standard Deviation 0.04 • Interval 7.0 to 13.0

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

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

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

Outcome measures

Outcome measures
Measure	Ovarian n=6 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=20 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=11 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=51 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=6 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=57 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Any Daily G-CSF	3.67 days Standard Deviation 1.63	3.95 days Standard Deviation 1.18 • Interval 8.0 to 42.0	4.95 days Standard Deviation 1.31 • Interval 2.0 to 38.0	4.77 days Standard Deviation 1.72 • Interval 2.0 to 16.0	5.85 days Standard Deviation 2.64 • Interval 3.0 to 56.0	4.88 days Standard Deviation 1.84 • Interval 3.0 to 17.0

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: Full analysis set participants who received secondary prophylaxis with pegfilgrastim

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

Outcome measures

Outcome measures
Measure	Ovarian n=11 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=14 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=15 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=92 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=9 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=101 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Pegfilgrastim	1.00 days Standard Deviation 0.00	1.00 days Standard Deviation 0.00 • Interval 16.0 to 61.0	1.04 days Standard Deviation 0.12 • Interval 20.0 to 64.0	1.02 days Standard Deviation 0.21 • Interval 8.0 to 23.0	1.00 days Standard Deviation 0.00 • Interval 12.0 to 65.0	1.02 days Standard Deviation 0.20 • Interval 10.0 to 24.0

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

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

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

Outcome measures

Outcome measures
Measure	Ovarian n=15 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=24 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=13 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=64 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=9 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=73 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Any Daily G-CSF	3.66 days Standard Deviation 1.82 • Interval 11.0 to 52.0	4.28 days Standard Deviation 0.87 • Interval 4.0 to 31.0	4.04 days Standard Deviation 1.61 • Interval 4.0 to 42.0	4.74 days Standard Deviation 2.64 • Interval 12.0 to 32.0	3.50 days Standard Deviation 0.95 • Interval 6.0 to 55.0	4.58 days Standard Deviation 2.53 • Interval 13.0 to 31.0

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: Full analysis set participants who received treatment with pegfilgrastim

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

Outcome measures

Outcome measures
Measure	Ovarian n=5 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=2 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=1 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Number of Days of Treatment in Participants Receiving Treatment With Pegfilgrastim	1.40 days Standard Deviation 0.89	1.00 days Standard Deviation 0.00	1.00 days Standard Deviation NA Not calculated as N=1	—	—	—

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

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

Outcome measures

Outcome measures
Measure	Ovarian n=9 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=15 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=8 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=17 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=4 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=21 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Number of Days of Treatment in Participants Receiving Treatment With Any Daily G-CSF	3.11 days Standard Deviation 1.92 • Interval 19.0 to 73.0	4.45 days Standard Deviation 1.18 • Interval 4.0 to 38.0	2.83 days Standard Deviation 1.21 • Interval 2.0 to 47.0	2.95 days Standard Deviation 1.50 • Interval 3.0 to 34.0	2.38 days Standard Deviation 0.75 • Interval 5.0 to 70.0	2.84 days Standard Deviation 1.39 • Interval 5.0 to 35.0

SECONDARY outcome

Timeframe: Cycles 2 - 8 (approximately 21 weeks)

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

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.

Outcome measures

Outcome measures
Measure	Ovarian n=147 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=204 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=124 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=734 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=87 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=822 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 > 3 Days Delay in One or More Cycles	48 percentage of participants Interval 40.0 to 56.0	46 percentage of participants Interval 39.0 to 52.0	52 percentage of participants Interval 44.0 to 61.0	29 percentage of participants Interval 26.0 to 32.0	47 percentage of participants Interval 37.0 to 58.0	31 percentage of participants Interval 28.0 to 34.0
Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 > 5 Days Delay in One or More Cycles	39 percentage of participants Interval 32.0 to 48.0	39 percentage of participants Interval 33.0 to 46.0	47 percentage of participants Interval 38.0 to 56.0	22 percentage of participants Interval 19.0 to 25.0	40 percentage of participants Interval 31.0 to 51.0	24 percentage of participants Interval 21.0 to 27.0
Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 > 7 Days Delay in One or More Cycles	24 percentage of participants Interval 18.0 to 31.0	23 percentage of participants Interval 18.0 to 29.0	26 percentage of participants Interval 19.0 to 34.0	9 percentage of participants Interval 7.0 to 11.0	21 percentage of participants Interval 14.0 to 30.0	10 percentage of participants Interval 8.0 to 12.0

SECONDARY outcome

Timeframe: Cycles 2 - 8 (approximately 21 days)

Population: 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.

Outcome measures

Outcome measures
Measure	Ovarian n=622 Total cycles Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=585 Total cycles Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=473 Total cycles Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=3697 Total cycles Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=402 Total cycles Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=4104 Total cycles Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Cycles With Chemotherapy Dose Delays > 3 Days Delay in One or More Cycles	20 percentage of cycles	24 percentage of cycles	24 percentage of cycles	7 percentage of cycles	17 percentage of cycles	8 percentage of cycles
Percentage of Cycles With Chemotherapy Dose Delays > 5 Days Delay in One or More Cycles	16 percentage of cycles	19 percentage of cycles	19 percentage of cycles	5 percentage of cycles	14 percentage of cycles	6 percentage of cycles
Percentage of Cycles With Chemotherapy Dose Delays > 7 Days Delay in One or More Cycles	7 percentage of cycles	9 percentage of cycles	8 percentage of cycles	2 percentage of cycles	6 percentage of cycles	2 percentage of cycles Interval to 12.0

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

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

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.

Outcome measures

Outcome measures
Measure	Ovarian n=152 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=219 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=137 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=732 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=89 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=822 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants With Chemotherapy Dose Reductions	34 percentage of participants Interval 27.0 to 42.0	25 percentage of participants Interval 20.0 to 31.0	22 percentage of participants Interval 16.0 to 30.0	16 percentage of participants Interval 13.0 to 19.0	29 percentage of participants Interval 21.0 to 39.0	17 percentage of participants Interval 15.0 to 20.0

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: 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.

Outcome measures

Outcome measures
Measure	Ovarian n=757 Total cycles Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=791 Total cycles Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=610 Total cycles Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=4399 Total cycles Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=486 Total cycles Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=4891 Total cycles Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Cycles With Chemotherapy Dose Reductions	16 percentage of cycles Interval 27.0 to 42.0	13 percentage of cycles Interval 20.0 to 31.0	12 percentage of cycles Interval 16.0 to 30.0	6 percentage of cycles Interval 13.0 to 19.0	16 percentage of cycles Interval 21.0 to 39.0	7 percentage of cycles Interval 15.0 to 20.0

SECONDARY outcome

Timeframe: Cycles 2 - 8 (approximately 21 weeks)

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

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

Outcome measures

Outcome measures
Measure	Ovarian n=124 Cycles with > 3 days delay Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=142 Cycles with > 3 days delay Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=113 Cycles with > 3 days delay Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=268 Cycles with > 3 days delay Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=70 Cycles with > 3 days delay Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=338 Cycles with > 3 days delay Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 Gastrointestinal Toxicity	3 cycles	0 cycles	2 cycles	3 cycles	1 cycles	4 cycles
Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 Missing	18 cycles	16 cycles	14 cycles	18 cycles	10 cycles	28 cycles
Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 Hepatic Toxicity	1 cycles	0 cycles	1 cycles	4 cycles	0 cycles	4 cycles
Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 Other Non-Hematological Reason	14 cycles	21 cycles	20 cycles	44 cycles	6 cycles	50 cycles
Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 Dose Administration Error	0 cycles	3 cycles	0 cycles	0 cycles	0 cycles	0 cycles
Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 Participant Preference	19 cycles	19 cycles	15 cycles	51 cycles	16 cycles	67 cycles
Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 Other	24 cycles	33 cycles	34 cycles	78 cycles	19 cycles	97 cycles
Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 Febrile Neutropenia	1 cycles	6 cycles	6 cycles	12 cycles	3 cycles	15 cycles
Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 Chemotherapy Induced Neutropenia	27 cycles	34 cycles	14 cycles	41 cycles	9 cycles	50 cycles
Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 Chemotherapy Induced Anemia	5 cycles	7 cycles	1 cycles	3 cycles	0 cycles	3 cycles Interval to 12.0
Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 Chemotherapy Induced Thrombocytopenia	7 cycles	0 cycles	4 cycles	1 cycles	1 cycles	2 cycles
Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 Other Hematological Reason	2 cycles	1 cycles	1 cycles	8 cycles	2 cycles	10 cycles
Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 Neurological Toxicity	3 cycles	2 cycles	1 cycles	5 cycles	3 cycles	8 cycles

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

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

Outcome measures

Outcome measures
Measure	Ovarian n=123 Cycles with ≥ 15% dose reduction Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=99 Cycles with ≥ 15% dose reduction Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=71 Cycles with ≥ 15% dose reduction Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=256 Cycles with ≥ 15% dose reduction Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=77 Cycles with ≥ 15% dose reduction Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=333 Cycles with ≥ 15% dose reduction Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 Chemotherapy induced neutropenia	15 cycles	16 cycles	3 cycles	41 cycles	11 cycles	52 cycles
Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 Chemotherapy induced anemia	3 cycles	7 cycles	2 cycles	2 cycles	0 cycles	2 cycles
Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 Other	16 cycles	19 cycles	11 cycles	20 cycles	10 cycles	30 cycles
Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 Participant preference	2 cycles	0 cycles	0 cycles	0 cycles	0 cycles	0 cycles
Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 Febrile neutropenia	4 cycles Interval 27.0 to 42.0	4 cycles Interval 20.0 to 31.0	3 cycles Interval 16.0 to 30.0	15 cycles Interval 13.0 to 19.0	6 cycles Interval 21.0 to 39.0	21 cycles Interval 15.0 to 20.0
Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 Chemotherapy induced thrombocytopenia	5 cycles	4 cycles	2 cycles	0 cycles	1 cycles	1 cycles
Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 Other hematological reason	1 cycles	1 cycles	2 cycles	0 cycles	0 cycles	0 cycles
Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 Gastrointestinal toxicity	4 cycles	2 cycles	1 cycles	12 cycles	2 cycles	14 cycles
Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 Neurological toxicity	2 cycles	2 cycles	2 cycles	17 cycles	0 cycles	17 cycles
Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 Hepatic toxicity	0 cycles	1 cycles	2 cycles	0 cycles	0 cycles	0 cycles
Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 Other non-hematological reason	31 cycles	13 cycles	10 cycles	33 cycles	8 cycles	41 cycles
Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 Weight loss	1 cycles	1 cycles	5 cycles	0 cycles	1 cycles	1 cycles
Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 Dose administration error	1 cycles	0 cycles	0 cycles	1 cycles	2 cycles	3 cycles
Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 Reduced to assess dose/tolerability	2 cycles	6 cycles	1 cycles	6 cycles	1 cycles	7 cycles
Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 Missing	36 cycles	23 cycles	27 cycles	109 cycles	35 cycles	144 cycles

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: Full analysis set

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

Outcome measures

Outcome measures
Measure	Ovarian n=157 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=224 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=137 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=738 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=90 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=829 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Number of Participants With Systemic Anti-infective Use in Cycles 1 to 8	23 participants	46 participants	53 participants	198 participants	20 participants	218 participants

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: Full analysis set

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

Outcome measures

Outcome measures
Measure	Ovarian n=157 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=224 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=137 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=738 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=90 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=829 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Number of Participants With Unplanned Hospitalizations	26 participants	52 participants	41 participants	107 participants	18 participants	125 participants

SECONDARY outcome

Timeframe: End of treatment (approximately 24 weeks)

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Ovarian n=157 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=224 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=137 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=738 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=90 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=829 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Investigator Assessed Clinical Response at End of Treatment Complete response	49 participants	8 participants	17 participants	218 participants	4 participants	222 participants
Investigator Assessed Clinical Response at End of Treatment Partial response	29 participants	60 participants	38 participants	77 participants	36 participants	114 participants
Investigator Assessed Clinical Response at End of Treatment Stable disease/No response	23 participants	41 participants	29 participants	35 participants	11 participants	46 participants
Investigator Assessed Clinical Response at End of Treatment Progressive disease	31 participants	64 participants	33 participants	8 participants	18 participants	26 participants
Investigator Assessed Clinical Response at End of Treatment Not done	25 participants	51 participants	20 participants	383 participants	21 participants	404 participants
Investigator Assessed Clinical Response at End of Treatment Missing	0 participants	0 participants	0 participants	17 participants	0 participants	17 participants

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: 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.

Outcome measures

Outcome measures
Measure	Ovarian n=157 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=224 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=137 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=738 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=90 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=829 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Number of Participants With Hematological Toxicities Grade 4 hemoglobin	1 participants	6 participants	5 participants	9 participants	3 participants	12 participants
Number of Participants With Hematological Toxicities Grade 3 platelets	8 participants	2 participants	3 participants	6 participants	3 participants	9 participants
Number of Participants With Hematological Toxicities Grade 4 platelets	3 participants	3 participants	4 participants	3 participants	0 participants	3 participants
Number of Participants With Hematological Toxicities Grade 3 absolute neutrophil count	19 participants	7 participants	9 participants	45 participants	5 participants	50 participants
Number of Participants With Hematological Toxicities Grade 4 absolute neutrophil count	23 participants	18 participants	13 participants	89 participants	18 participants	107 participants
Number of Participants With Hematological Toxicities Grade 3 white blood cells	17 participants	11 participants	5 participants	71 participants	8 participants	79 participants
Number of Participants With Hematological Toxicities Grade 4 white blood cells	6 participants	8 participants	11 participants	38 participants	12 participants	50 participants
Number of Participants With Hematological Toxicities Grade 3 hemoglobin	6 participants	12 participants	15 participants	47 participants	7 participants	54 participants

SECONDARY outcome

Timeframe: From cycle 1, day 1 until end of the long-term follow-up; median time on follow-up from cycle 1, day 1 was 52 months.

Population: 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.

Outcome measures

Outcome measures
Measure	Ovarian n=157 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=224 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=137 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=738 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=90 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=829 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Time to Disease Progression	12.4 months Interval 9.9 to 16.4	6.5 months Interval 4.5 to 7.8	6.8 months Interval 6.4 to 7.9	NA months Not estimable due to the low number of events	11.8 months Interval 9.1 to 16.4	NA months Not estimable due to the low number of events

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: Participants who received treatment with an ESA

Outcome measures

Outcome measures
Measure	Ovarian n=147 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Duration of Treatment With Erythropoiesis-stimulating Agents (ESAs)	5.3 weeks Standard Deviation 4.6	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: 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.

Outcome measures

Outcome measures
Measure	Ovarian n=147 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Reason for Treatment With Erythropoiesis-stimulating Agents Hemoglobin level	134 participants 4.6	—	—	—	—	—
Reason for Treatment With Erythropoiesis-stimulating Agents Risk of chemotherapy induced anemia	10 participants	—	—	—	—	—
Reason for Treatment With Erythropoiesis-stimulating Agents Evidence based guidelines	3 participants	—	—	—	—	—
Reason for Treatment With Erythropoiesis-stimulating Agents Other anemia-related symptoms	3 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: Participants who received treatment with an ESA

Outcome measures

Outcome measures
Measure	Ovarian n=147 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Hemoglobin Level at Initiation of Erythropoiesis-stimulating Agent Treatment Hemoglobin > 11 g/dL	29 participants	—	—	—	—	—
Hemoglobin Level at Initiation of Erythropoiesis-stimulating Agent Treatment Hemoglobin < 9 g/dL	19 participants 4.6	—	—	—	—	—
Hemoglobin Level at Initiation of Erythropoiesis-stimulating Agent Treatment Hemoglobin 9 - 11 g/dL	95 participants	—	—	—	—	—
Hemoglobin Level at Initiation of Erythropoiesis-stimulating Agent Treatment Missing	4 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: Full analysis set

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.

Outcome measures

Outcome measures
Measure	Ovarian n=147 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=1200 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Number of Clinical Visits in Cycles 1-8 by ESA Use Visits per month during cycles 1 - 8	3.1 visits per month Standard Deviation 1.6	2.8 visits per month Standard Deviation 1.7	—	—	—	—
Number of Clinical Visits in Cycles 1-8 by ESA Use Visits per month during period of ESA treatment	3.9 visits per month Standard Deviation 3.2	NA visits per month Standard Deviation NA Participants in this group did not receive any ESA treatment	—	—	—	—

SECONDARY outcome

Timeframe: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.

Population: Participants who received treatment with an ESA and still on study 5 weeks after initiation of ESA treatment.

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.

Outcome measures

Outcome measures
Measure	Ovarian n=105 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants Who Received ESAs and Required a Red Blood Cell (RBC) Transfusion After 5 Weeks of ESA Treatment	11 percentage of participants 95% Confidence Interval 4.6 • Interval 3.0 to 19.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Initiation of ESA treatment (last assessment on or prior to ESA day 1) and at end of ESA treatment; median duration of ESA treatment was 4 weeks, maximum was 23 weeks.

Population: Participants who received treatment with an ESA and with hemoglobin measurements available at both time points.

Outcome measures

Outcome measures
Measure	Ovarian n=121 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Change in Hemoglobin During ESA Treatment Phase	0.38 g/dL Standard Deviation 1.30	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: Participants who received treatment with an ESA

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.

Outcome measures

Outcome measures
Measure	Ovarian n=147 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants Who Received ESAs and Achieved Hematopoietic Response	45 percentage of participants 95% Confidence Interval 4.6 • Interval 29.0 to 61.0	—	—	—	—	—

SECONDARY outcome

Timeframe: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.

Population: Participants who received treatment with an ESA and with hemoglobin \< 9 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of 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.

Outcome measures

Outcome measures
Measure	Ovarian n=14 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 9 g/dL After 5 Weeks ESA Treatment	58 percentage of participants 95% Confidence Interval 4.6 • Interval -1.0 to 118.0	—	—	—	—	—

SECONDARY outcome

Timeframe: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.

Population: Participants who received treatment with an ESA, and with hemoglobin \< 10 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.

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.

Outcome measures

Outcome measures
Measure	Ovarian n=41 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 10 g/dL After 5 Weeks ESA Treatment	85 percentage of participants 95% Confidence Interval 4.6 • Interval 61.0 to 108.0	—	—	—	—	—

SECONDARY outcome

Timeframe: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.

Population: Participants who received treatment with an ESA, and with hemoglobin \< 11 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.

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.

Outcome measures

Outcome measures
Measure	Ovarian n=82 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 11 g/dL After 5 Weeks ESA Treatment	66 percentage of participants 95% Confidence Interval 4.6 • Interval 51.0 to 82.0	—	—	—	—	—

SECONDARY outcome

Timeframe: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.

Population: Participants who received treatment with an ESA, and with hemoglobin \< 12 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.

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.

Outcome measures

Outcome measures
Measure	Ovarian n=97 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 12 g/dL After 5 Weeks ESA Treatment	35 percentage of participants 95% Confidence Interval 4.6 • Interval 17.0 to 53.0	—	—	—	—	—

SECONDARY outcome

Timeframe: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.

Population: Participants who received treatment with an ESA, and with hemoglobin \< 10 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.

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.

Outcome measures

Outcome measures
Measure	Ovarian n=41 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL After 5 Weeks ESA Treatment	84 percentage of participants 95% Confidence Interval 4.6 • Interval 58.0 to 109.0	—	—	—	—	—

SECONDARY outcome

Timeframe: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.

Population: Participants who received treatment with an ESA, and with hemoglobin \< 12 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.

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.

Outcome measures

Outcome measures
Measure	Ovarian n=97 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 12 to 13 g/dL After 5 Weeks ESA Treatment	30 percentage of participants 95% Confidence Interval 4.6 • Interval 15.0 to 45.0	—	—	—	—	—

SECONDARY outcome

Timeframe: 9 weeks post initiation of ESA treatment

Population: Participants who received treatment with an ESA

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

Outcome measures

Outcome measures
Measure	Ovarian n=147 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL 9 Weeks After Initiation of ESA Treatment	15 percentage of participants 95% Confidence Interval 4.6 • Interval 10.0 to 22.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: Full analysis set

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

Outcome measures

Outcome measures
Measure	Ovarian n=157 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=224 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=137 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=738 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=90 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=829 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Number of Participants With Systemic Transfusions in Cycles 1 to 8	20 participants	23 participants	26 participants	25 participants	4 participants	29 participants

SECONDARY outcome

Timeframe: Cycles 1 - 8 (approximately 24 weeks)

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Ovarian n=157 Participants Participants diagnosed with ovarian cancer and receiving chemotherapy.	NSCLC n=224 Participants Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.	SCLC n=137 Participants Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.	Breast Stage I-III n=738 Participants Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.	Breast Metastatic n=90 Participants Participants diagnosed with metastatic breast cancer and receiving chemotherapy.	Breast Total n=829 Participants Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
Number of Transfusions Per Participant in Cycles 1 to 8 No Transfusions	137 participants	201 participants	111 participants	713 participants	86 participants	800 participants
Number of Transfusions Per Participant in Cycles 1 to 8 1 Transfusion	8 participants	16 participants	17 participants	19 participants	2 participants	21 participants
Number of Transfusions Per Participant in Cycles 1 to 8 2 Transfusions	4 participants	4 participants	5 participants	3 participants	1 participants	4 participants
Number of Transfusions Per Participant in Cycles 1 to 8 > 2 Transfusions	8 participants	3 participants	4 participants	3 participants	1 participants	4 participants

Adverse Events

Ovarian

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

NSCLC

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

SCLC

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Breast Stage I-III

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Breast Metastatic

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Breast Total

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ovarian n=157 participants at risk Ovarian Cancer	NSCLC n=224 participants at risk Non-small Cell Lung Cancer	SCLC n=137 participants at risk Small Cell Lung Cancer	Breast Stage I-III n=738 participants at risk Breast Cancer, Stages I-III	Breast Metastatic n=90 participants at risk Breast Cancer, Metastatic	Breast Total n=829 participants at risk All Breast Cancer
General disorders CHEST PAIN	0.00% 0/157 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	0.00% 0/224 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	0.00% 0/137 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	0.14% 1/738 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	0.00% 0/90 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	0.12% 1/829 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/157 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	0.00% 0/224 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	0.00% 0/137 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	0.14% 1/738 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	0.00% 0/90 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	0.12% 1/829 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/157 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	0.45% 1/224 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	0.00% 0/137 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	0.00% 0/738 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	0.00% 0/90 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	0.00% 0/829 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.

Other adverse events

Other adverse events
Measure	Ovarian n=157 participants at risk Ovarian Cancer	NSCLC n=224 participants at risk Non-small Cell Lung Cancer	SCLC n=137 participants at risk Small Cell Lung Cancer	Breast Stage I-III n=738 participants at risk Breast Cancer, Stages I-III	Breast Metastatic n=90 participants at risk Breast Cancer, Metastatic	Breast Total n=829 participants at risk All Breast Cancer
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.64% 1/157 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	0.00% 0/224 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	0.73% 1/137 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	5.0% 37/738 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	1.1% 1/90 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.	4.6% 38/829 • Approximately 24 weeks (8 treatment cycles) Only adverse drug reactions (ADRs) considered by the investigator to be related to Amgen products were collected. Any ADRs relating to pegfilgrastim, filgrastim, and darbepoetin alfa are reported. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the 5% frequency threshold.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER