Trial Outcomes & Findings for Chemotherapy Administered Every 2 Weeks With or Without Pegfilgrastim in Subjects With Advanced or Metastatic Colon Cancer (NCT NCT00094809)

Last Updated: 2018-10-17

Results Overview

Grade 3 or 4 neutropenia, defined as an absolute neutrophil count (ANC) \< 1 x 10\^9/L, in any of the first four cycles of treatment

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

252 participants

Primary outcome timeframe

First 4 cycles of treatment (8 weeks)

Results posted on

2018-10-17

Participant Flow

Participants were enrolled from 12 February 2003 through 13 January 2006

Participant milestones

Participant milestones
Measure	Pegfilgrastim (Neulasta) Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion	Placebo Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
Overall Study STARTED	126	126
Overall Study Received Study Drug	124	118
Overall Study Properly Consented; Received Study Drug	123	118
Overall Study Completed All 4 Cycles of Treatment	98	90
Overall Study COMPLETED	74	61
Overall Study NOT COMPLETED	52	65

Reasons for withdrawal

Reasons for withdrawal
Measure	Pegfilgrastim (Neulasta) Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion	Placebo Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
Overall Study Protocol deviation	2	2
Overall Study Noncompliance	1	0
Overall Study Adverse Event	3	1
Overall Study Withdrawal by Subject	8	9
Overall Study Disease progression	3	3
Overall Study Physician Decision	3	5
Overall Study Lost to Follow-up	6	6
Overall Study Death	19	25
Overall Study Protocol-specified criteria	1	1
Overall Study Other	1	1
Overall Study Informed consent signed after treatment	1	0
Overall Study Study drug not received	2	8

Baseline Characteristics

Chemotherapy Administered Every 2 Weeks With or Without Pegfilgrastim in Subjects With Advanced or Metastatic Colon Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pegfilgrastim (Neulasta) n=123 Participants Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion	Placebo n=118 Participants Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion	Total n=241 Participants Total of all reporting groups
Age, Continuous	62.4 Years STANDARD_DEVIATION 12.26 • n=99 Participants	62.9 Years STANDARD_DEVIATION 13.21 • n=107 Participants	62.7 Years STANDARD_DEVIATION 12.71 • n=206 Participants
Sex: Female, Male Female	45 Participants n=99 Participants	34 Participants n=107 Participants	79 Participants n=206 Participants
Sex: Female, Male Male	78 Participants n=99 Participants	84 Participants n=107 Participants	162 Participants n=206 Participants
Race/Ethnicity, Customized White or Caucasian	103 Participants n=99 Participants	84 Participants n=107 Participants	187 Participants n=206 Participants
Race/Ethnicity, Customized Black or African American	12 Participants n=99 Participants	12 Participants n=107 Participants	24 Participants n=206 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=99 Participants	16 Participants n=107 Participants	19 Participants n=206 Participants
Race/Ethnicity, Customized Asian	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Race/Ethnicity, Customized Japanese	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants
Race/Ethnicity, Customized Other	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Chemotherapy Regimen FOIL	30 Participants n=99 Participants	30 Participants n=107 Participants	60 Participants n=206 Participants
Chemotherapy Regimen FOLFOX	61 Participants n=99 Participants	58 Participants n=107 Participants	119 Participants n=206 Participants
Chemotherapy Regimen FOLFIRI	32 Participants n=99 Participants	30 Participants n=107 Participants	62 Participants n=206 Participants

PRIMARY outcome

Timeframe: First 4 cycles of treatment (8 weeks)

Population: Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures

Grade 3 or 4 neutropenia, defined as an absolute neutrophil count (ANC) \< 1 x 10\^9/L, in any of the first four cycles of treatment

Outcome measures

Outcome measures
Measure	Pegfilgrastim (Neulasta) n=123 Participants Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion	Placebo n=118 Participants Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
Grade 3 or 4 Neutropenia	16 Participants	51 Participants

PRIMARY outcome

Timeframe: First 4 cycles of treatment (8 weeks)

Population: Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures

Grade 4 neutropenia, defined as an absolute neutrophil count (ANC) \<0.5 x 10\^9/L, in any of the first four cycles of treatment

Outcome measures

Outcome measures
Measure	Pegfilgrastim (Neulasta) n=123 Participants Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion	Placebo n=118 Participants Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
Grade 4 Neutropenia	13 Participants	17 Participants

SECONDARY outcome

Timeframe: First 4 cycles of treatment (8 weeks)

Population: Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures

Dose delay or reduction in chemotherapy doses due to neutropenia

Outcome measures

Outcome measures
Measure	Pegfilgrastim (Neulasta) n=123 Participants Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion	Placebo n=118 Participants Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
Dose Delay or Reduction Due to Neutropenia	5 Participants	26 Participants

SECONDARY outcome

Timeframe: First 4 cycles of treatment (8 weeks)

Population: Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures

Dose delay or reduction in chemotherapy dose during the first 4 cycles for any reason

Outcome measures

Outcome measures
Measure	Pegfilgrastim (Neulasta) n=123 Participants Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion	Placebo n=118 Participants Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
Dose Delay or Reduction for Any Reason	41 Participants	53 Participants

SECONDARY outcome

Timeframe: First 4 cycles of treatment (8 weeks)

Population: Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures

Febrile neutropenia, Defined as a temperature ≥ 38.2 °C on a given day, with an ANC \< 1.0 x 10\^9/L recorded on the same day or the next day, during any of the first 4 cycles of treatment.

Outcome measures

Outcome measures
Measure	Pegfilgrastim (Neulasta) n=123 Participants Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion	Placebo n=118 Participants Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
Febrile Neutropenia	3 Participants	10 Participants

SECONDARY outcome

Timeframe: First 4 cycles of neutropenia (8 weeks)

Population: Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures

Hospitalization because of a neutropenia-related event during the first 4 cycles of treatment

Outcome measures

Outcome measures
Measure	Pegfilgrastim (Neulasta) n=123 Participants Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion	Placebo n=118 Participants Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
Hospitalization Due to a Neutropenia-Related Event	7 Participants	9 Participants

SECONDARY outcome

Timeframe: Up to 24 months after first four cycles of treatment

Population: Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures

Kaplan-Meier estimate of the median time to disease progression or death

Outcome measures

Outcome measures
Measure	Pegfilgrastim (Neulasta) n=123 Participants Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion	Placebo n=118 Participants Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
Progression-Free Survival	318 Days Interval 258.0 to 387.0	322 Days Interval 268.0 to 387.0

SECONDARY outcome

Timeframe: First 4 cycles of treatment (8 weeks)

Population: Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures

Objective tumor response (complete or partial) at the end of treatment, defined as a reduction of at least 50% in the area of all measurable lesions (partial response) or disappearance of all measurable or evaluable disease without the development of new lesions (complete response) on computed tomographic (CT) or other scanning.

Outcome measures

Outcome measures
Measure	Pegfilgrastim (Neulasta) n=123 Participants Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion	Placebo n=118 Participants Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
Objective Tumor Response	34 Participants	37 Participants

SECONDARY outcome

Timeframe: Up to 24 months after first four cycles of treatment

Population: Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures.

Death from any cause through the end of the follow-up period

Outcome measures

Outcome measures
Measure	Pegfilgrastim (Neulasta) n=123 Participants Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion	Placebo n=118 Participants Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
Survival	47 Participants	49 Participants

SECONDARY outcome

Timeframe: First 4 cycles of treatment (8 weeks)

Population: Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures

Antibiotic use during any of the first 4 cycles of treatment due to febrile neutropenia.

Outcome measures

Outcome measures
Measure	Pegfilgrastim (Neulasta) n=123 Participants Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion	Placebo n=118 Participants Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
Antibiotic Use Due to Febrile Neutropenia	2 Participants	8 Participants

Adverse Events

Placebo

Serious events: 36 serious events

Other events: 108 other events

Deaths: 0 deaths

Pegfilgrastim

Serious events: 44 serious events

Other events: 112 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

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 multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Placebo n=117 participants at risk	Pegfilgrastim n=124 participants at risk
Blood and lymphatic system disorders Agranulocytosis	0.85% 1/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.00% 0/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Blood and lymphatic system disorders Anaemia	0.00% 0/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	1.6% 2/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Blood and lymphatic system disorders Coagulopathy	0.85% 1/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.00% 0/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.85% 1/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.00% 0/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Blood and lymphatic system disorders Febrile neutropenia	5.1% 6/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	2.4% 3/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Blood and lymphatic system disorders Leukopenia	0.85% 1/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.00% 0/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Blood and lymphatic system disorders Neutropenia	1.7% 2/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	5.6% 7/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Cardiac disorders Acute myocardial infarction	0.00% 0/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.81% 1/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Cardiac disorders Atrial fibrillation	0.85% 1/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.81% 1/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Cardiac disorders Cardiac failure congestive	0.00% 0/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.81% 1/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.81% 1/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Cardiac disorders Myocardial infarction	1.7% 2/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.00% 0/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Abdominal distension	0.00% 0/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.81% 1/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Abdominal pain	2.6% 3/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.81% 1/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Abdominal pain upper	0.85% 1/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.00% 0/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Ascites	0.00% 0/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.81% 1/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Colon gangrene	0.85% 1/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.00% 0/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Constipation	0.00% 0/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	1.6% 2/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Diarrhoea	2.6% 3/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	5.6% 7/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Faecal incontinence	0.85% 1/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.00% 0/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Faecaloma	0.85% 1/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.00% 0/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.7% 2/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.81% 1/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Haematemesis	0.85% 1/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.00% 0/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Ileus	0.00% 0/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.81% 1/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Inguinal hernia	0.85% 1/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.00% 0/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Intestinal obstruction	0.85% 1/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.81% 1/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Nausea	6.0% 7/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	1.6% 2/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Proctalgia	0.00% 0/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.81% 1/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Small intestinal obstruction	0.85% 1/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.81% 1/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Vomiting	5.1% 6/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	1.6% 2/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
General disorders Asthenia	0.00% 0/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.81% 1/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
General disorders Chest pain	1.7% 2/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.00% 0/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
General disorders Disease progression	0.85% 1/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.00% 0/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
General disorders Oedema peripheral	0.85% 1/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.00% 0/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
General disorders Pain	0.00% 0/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.81% 1/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
General disorders Pyrexia	1.7% 2/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	2.4% 3/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Infections and infestations Abdominal abscess	0.00% 0/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.81% 1/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Infections and infestations Catheter sepsis	0.00% 0/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.81% 1/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Infections and infestations Enterocolitis infectious	0.00% 0/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	0.81% 1/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Infections and infestations Gastroenteritis	0.85% 1/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	1.6% 2/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.

Other adverse events
Measure	Placebo n=117 participants at risk	Pegfilgrastim n=124 participants at risk
Blood and lymphatic system disorders Anaemia	27.4% 32/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	29.0% 36/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Blood and lymphatic system disorders Leukocytosis	2.6% 3/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	5.6% 7/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Blood and lymphatic system disorders Neutropenia	47.0% 55/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	8.9% 11/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Blood and lymphatic system disorders Thrombocytopenia	7.7% 9/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	7.3% 9/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Abdominal distension	0.00% 0/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	5.6% 7/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Abdominal pain	13.7% 16/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	17.7% 22/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Abdominal pain upper	1.7% 2/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	6.5% 8/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Constipation	11.1% 13/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	11.3% 14/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Diarrhoea	45.3% 53/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	50.0% 62/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Dyspepsia	2.6% 3/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	5.6% 7/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Mouth ulceration	3.4% 4/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	5.6% 7/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Nausea	45.3% 53/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	55.6% 69/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Stomatitis	6.8% 8/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	6.5% 8/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Gastrointestinal disorders Vomiting	18.8% 22/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	28.2% 35/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
General disorders Asthenia	5.1% 6/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	17.7% 22/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
General disorders Chest pain	1.7% 2/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	6.5% 8/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
General disorders Fatigue	37.6% 44/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	39.5% 49/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
General disorders Mucosal inflammation	5.1% 6/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	6.5% 8/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
General disorders Oedema peripheral	5.1% 6/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	6.5% 8/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
General disorders Pain	12.0% 14/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	6.5% 8/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
General disorders Pyrexia	7.7% 9/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	14.5% 18/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Investigations Weight decreased	6.8% 8/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	15.3% 19/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Metabolism and nutrition disorders Anorexia	12.0% 14/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	23.4% 29/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Metabolism and nutrition disorders Decreased appetite	3.4% 4/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	8.1% 10/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Metabolism and nutrition disorders Dehydration	8.5% 10/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	11.3% 14/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Metabolism and nutrition disorders Hypokalaemia	1.7% 2/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	14.5% 18/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Musculoskeletal and connective tissue disorders Back pain	4.3% 5/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	8.1% 10/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Musculoskeletal and connective tissue disorders Bone pain	0.85% 1/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	10.5% 13/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Nervous system disorders Dizziness	4.3% 5/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	6.5% 8/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Nervous system disorders Headache	6.0% 7/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	7.3% 9/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Nervous system disorders Hypoaesthesia	6.0% 7/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	6.5% 8/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Nervous system disorders Neuropathy	4.3% 5/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	6.5% 8/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Nervous system disorders Neuropathy peripheral	2.6% 3/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	5.6% 7/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Nervous system disorders Paraesthesia	4.3% 5/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	8.1% 10/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Psychiatric disorders Anxiety	5.1% 6/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	3.2% 4/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Psychiatric disorders Depression	3.4% 4/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	7.3% 9/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Psychiatric disorders Insomnia	7.7% 9/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	14.5% 18/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Respiratory, thoracic and mediastinal disorders Cough	5.1% 6/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	8.1% 10/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.4% 4/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	9.7% 12/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.7% 9/117 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.	4.8% 6/124 • During treatment period and including 30 days after last dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject randomized to pegfilgrastim arm was not summarized in the safety analysis set due to improper informed consent. Another subject who was randomized to placebo arm but received pegfilgrastim and was summarized in pegfilgrastim arm.