Trial Outcomes & Findings for Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study (NCT NCT02454530)

Last Updated: 2019-06-28

Results Overview

The factors which determined the use of Nivestim among participants included participant's sex, young participant, elderly participant, past history of infection, comorbidities, life expectancy, past history of febrile neutropenia and severe neutropenia, occupational activity, family activity and other important criteria. Percentage of participants were categorized based upon the level of importance under different categories which included very important, important, relatively important, not important and not applicable.

Recruitment status

TERMINATED

Target enrollment

1160 participants

Primary outcome timeframe

Inclusion visit (Week 1)

Results posted on

2019-06-28

Participant Flow

Between September 2014 and September 2016, 102 public and/or private hospital-based oncologists included 1160 patients with solid tumor treated with cytotoxic chemotherapy and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated. The study was conducted in France.

Participant milestones

Participant milestones
Measure	Adjuvant Chemotherapy Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Overall Study STARTED	552	608
Overall Study COMPLETED	482	481
Overall Study NOT COMPLETED	70	127

Reasons for withdrawal

Reasons for withdrawal
Measure	Adjuvant Chemotherapy Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Overall Study Other	8	13
Overall Study Missing information	56	69
Overall Study Death	2	41
Overall Study Lost to Follow-up	4	4

Baseline Characteristics

Here, 'Number analyzed' signifies number of participants evaluable for this baseline characteristics.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adjuvant Chemotherapy n=551 Participants Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy n=603 Participants Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.	Total n=1154 Participants Total of all reporting groups
Age, Continuous	60.3 years STANDARD_DEVIATION 12.1 • n=551 Participants • Here, 'Number analyzed' signifies number of participants evaluable for this baseline characteristics.	65.0 years STANDARD_DEVIATION 11.0 • n=599 Participants • Here, 'Number analyzed' signifies number of participants evaluable for this baseline characteristics.	62.7 years STANDARD_DEVIATION 11.8 • n=1150 Participants • Here, 'Number analyzed' signifies number of participants evaluable for this baseline characteristics.
Sex/Gender, Customized Female	399 Participants n=551 Participants	324 Participants n=603 Participants	723 Participants n=1154 Participants
Sex/Gender, Customized Male	149 Participants n=551 Participants	277 Participants n=603 Participants	426 Participants n=1154 Participants
Sex/Gender, Customized Missing	3 Participants n=551 Participants	2 Participants n=603 Participants	5 Participants n=1154 Participants

PRIMARY outcome

Timeframe: Inclusion visit (Week 1)

Population: Analysis population included all participants who received at least one dose of Nivestim and did not had a major deviation from the protocol. Here 'Number analyzed' signifies number of participants evaluable for specified categories.

Outcome measures

Outcome measures
Measure	Adjuvant Chemotherapy n=551 Participants Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy n=603 Participants Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Occupational activity:NI	26.6 Percentage of participants	29.4 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Occupational activity: NA	34.4 Percentage of participants	38.5 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Family activity: VI	2.9 Percentage of participants	1.0 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Family activity: RU	22.4 Percentage of participants	18.5 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Family activity: NI	26.4 Percentage of participants	28.8 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Family activity: NA	33.0 Percentage of participants	38.6 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Other VI/ Important criteria	17.2 Percentage of participants	21.4 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Past history of infection: Important	22.5 Percentage of participants	25.7 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Past history of infection: RU	11.2 Percentage of participants	13.8 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Past history of infection: NI	17.2 Percentage of participants	17.6 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Past history of infection: NA	32.4 Percentage of participants	27.2 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Comorbidities: VI	19.6 Percentage of participants	20.4 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Comorbidities: Important	27.8 Percentage of participants	32.8 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Comorbidities: RU	15.6 Percentage of participants	15.0 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Comorbidities: NI	15.4 Percentage of participants	15.7 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Comorbidities: NA	21.6 Percentage of participants	16.2 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Life expectancy: VI	23.1 Percentage of participants	15.5 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Life expectancy: Important	26.4 Percentage of participants	31.4 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Life expectancy: RU	18.5 Percentage of participants	24.8 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Life expectancy: NI	14.5 Percentage of participants	15.2 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Life expectancy: NA	17.4 Percentage of participants	13.2 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Past history febrile neutropenia (FN): VI	29.9 Percentage of participants	29.7 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Past history FN: Important	7.5 Percentage of participants	12.2 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Past history FN: RU	7.1 Percentage of participants	7.0 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Past history FN: NI	13.9 Percentage of participants	13.8 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Past history FN: NA	41.6 Percentage of participants	37.2 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Past history of severe neutropenia (SN): VI	26.9 Percentage of participants	29.3 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Past history of SN: Important	16.1 Percentage of participants	19.2 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Past history of SN: RU	8.2 Percentage of participants	8.9 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Past history of SN: NI	11.9 Percentage of participants	10.9 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Past history of SN: NA	36.9 Percentage of participants	31.6 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Occupational activity: VI	2.6 Percentage of participants	1.8 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Occupational activity: Important	8.4 Percentage of participants	7.9 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Occupational activity: RU	28.0 Percentage of participants	22.4 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Family activity: Important	15.2 Percentage of participants	13.0 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Participant sex: Very important (VI)	2.7 Percentage of participants	1.7 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Participant sex: Important	11.2 Percentage of participants	7.2 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Participant sex: Relatively unimportant (RU)	24.5 Percentage of participants	22.5 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Participant sex: Not important (NI)	52.3 Percentage of participants	58.2 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Participant sex: Not applicable (NA)	9.3 Percentage of participants	10.4 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Young participant: VI	4.6 Percentage of participants	2.7 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Young participant: Important	17.2 Percentage of participants	9.3 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Young participant: RU	26.5 Percentage of participants	26.8 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Young participant: NI	24.5 Percentage of participants	27.1 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Young participant: NA	27.2 Percentage of participants	34.2 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Elderly participant: VI	22.3 Percentage of participants	20.8 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Elderly participant: Important	30.6 Percentage of participants	33.9 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Elderly Participant: RU	12.9 Percentage of participants	13.3 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Elderly participant: NI	12.7 Percentage of participants	14.4 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Elderly participant: NA	21.5 Percentage of participants	17.6 Percentage of participants
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim Past history of infection: VI	16.7 Percentage of participants	15.6 Percentage of participants

SECONDARY outcome

Timeframe: Follow-up visit (Week 3); End of study visit ( up to Week 19)

Population: Analysis population included all participants who received at least one dose of Nivestim and did not had a major deviation from the protocol. Here, 'Number analyzed' signifies number of participants evaluable for specified categories.

Chemotherapy is a type of cancer treatment that uses one or more anti-cancer drugs as a part of a standardize treatment regimen. Chemotherapy may be given with curative intent, or it may aim to prolong life or to reduce symptoms.

Outcome measures

Outcome measures
Measure	Adjuvant Chemotherapy n=551 Participants Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy n=603 Participants Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Number of Participants Who Continued Chemotherapy Follow up visit	514 Participants	524 Participants
Number of Participants Who Continued Chemotherapy End of study visit	111 Participants	202 Participants

SECONDARY outcome

Timeframe: Follow-up visit (Week 3); End of study visit ( up to Week 19)

Outcome measures

Outcome measures
Measure	Adjuvant Chemotherapy n=551 Participants Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy n=603 Participants Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Number of Participants Who Discontinued Chemotherapy Follow up visit	22 Participants	42 Participants
Number of Participants Who Discontinued Chemotherapy End of study visit	482 Participants	502 Participants

SECONDARY outcome

Timeframe: Follow-up visit (Week 3)

Population: Analysis population included all participants who received at least one dose of Nivestim and did not had a major deviation from the protocol. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure.

Outcome measures

Outcome measures
Measure	Adjuvant Chemotherapy n=22 Participants Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy n=42 Participants Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Number of Participants With Unplanned Discontinuation of Chemotherapy at Follow Up Visit	10 Participants	36 Participants

SECONDARY outcome

Timeframe: Follow-up visit (Week 3)

Neutropenia is an abnormally low level of neutrophils (count of less than 1,500 neutrophils per microliter (microL) in blood) and was classified as Grade 1 (mild) with an absolute neutrophil count (ANC) of 1000-1500 cells per microL, Grade 2 (moderate) with an ANC of 500-1000 cells per microL, or Grade 3 (severe) with an ANC lower than 500 cells per microL.

Outcome measures

Outcome measures
Measure	Adjuvant Chemotherapy n=12 Participants Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy n=15 Participants Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Number of Participants With Dose Reduction in Chemotherapy Due to Neutropenia	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Follow-up visit (Week 3)

Outcome measures

Outcome measures
Measure	Adjuvant Chemotherapy n=12 Participants Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy n=15 Participants Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Number of Participants With Delayed Administration of Chemotherapy Cycle Due to Neutropenia	1 Participants	0 Participants

SECONDARY outcome

Timeframe: End of study visit (up to Week 19)

The reasons for unplanned discontinuation of chemotherapy included neutropenia, febrile neutropenia, other toxicity, development of resistance to treatment and other. Also, one participant could have more than one reason for unplanned discontinuation.

Outcome measures

Outcome measures
Measure	Adjuvant Chemotherapy n=482 Participants Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy n=502 Participants Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Number of Participants With Unplanned Discontinuation of Chemotherapy at the End of Study Visit	39 Participants	136 Participants

SECONDARY outcome

Timeframe: End of study visit (up to Week 19)

Number of participants with change in chemotherapy protocol due to each conditions (neutropenia, febrile neutropenia, neutropenia/febrile neutropenia, other toxicity, neutropenia/other toxicity) has been reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Adjuvant Chemotherapy n=86 Participants Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy n=118 Participants Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Number of Participants With Change in Chemotherapy Protocol at End of Study Visit Other toxicity	57 Participants	89 Participants
Number of Participants With Change in Chemotherapy Protocol at End of Study Visit Neutropenia/Febrile neutropenia	2 Participants	0 Participants
Number of Participants With Change in Chemotherapy Protocol at End of Study Visit Neutropenia/Other toxicity	2 Participants	6 Participants
Number of Participants With Change in Chemotherapy Protocol at End of Study Visit Febrile neutropenia/Other toxicity	2 Participants	0 Participants
Number of Participants With Change in Chemotherapy Protocol at End of Study Visit Neutropenia	21 Participants	21 Participants
Number of Participants With Change in Chemotherapy Protocol at End of Study Visit Febrile neutropenia	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Follow-up visit (Week 3); End of study visit (up to Week 19)

Neutropenia is an abnormally low level of neutrophils (count of less than 1,500 neutrophils per microL in blood) and was classified as Grade 1 (mild) with an ANC of 1000-1500 cells per microL, Grade 2 (moderate) with an ANC of 500-1000 cells per microL, or Grade 3 (severe) with an ANC lower than 500 cells per microL. The incidence of neutropenia (between follow up and final visit) were described from the questionnaire completed by the investigator during the final visit. Febrile neutropenia was defined as tympanic or axillary body temperature greater than (\>) 38.5 degree celsius for \>1 hour and ANC less than (\<) 1.0 \*10\^9 neutrophils per liter. The incidence of febrile neutropenia were described from the questionnaire completed by the investigator during the follow-up and final visits. Only those categories which had atleast 1 abnormality have been reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Adjuvant Chemotherapy n=551 Participants Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy n=603 Participants Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Number of Participants With Neutropenia and Febrile Neutropenia Follow up visit: Febrile Neutropenia	21 Participants	19 Participants
Number of Participants With Neutropenia and Febrile Neutropenia Follow up visit: Neutropenia	21 Participants	21 Participants
Number of Participants With Neutropenia and Febrile Neutropenia Final visit: Febrile Neutropenia	9 Participants	16 Participants
Number of Participants With Neutropenia and Febrile Neutropenia Final visit: Neutropenia	63 Participants	75 Participants

SECONDARY outcome

Timeframe: Inclusion visit (Week 1), End of study visit (up to Week 19)

Change in the disease status of the participant was measured by the change in the count of neutrophils (NPs), platelets and leukocytes as reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Adjuvant Chemotherapy n=551 Participants Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy n=603 Participants Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Change From Inclusion Visit in Disease Status as Measured by Number of Neutrophil Cells (Neutrophils), Platelet Count and Leukocyte Count at End of Study NP count at Inclusion Visit	4.6 gram per liter (g/L) Standard Deviation 15.4	5.3 gram per liter (g/L) Standard Deviation 16.9
Change From Inclusion Visit in Disease Status as Measured by Number of Neutrophil Cells (Neutrophils), Platelet Count and Leukocyte Count at End of Study Change in NP count	-0.2 gram per liter (g/L) Standard Deviation 10.9	1.8 gram per liter (g/L) Standard Deviation 33.2
Change From Inclusion Visit in Disease Status as Measured by Number of Neutrophil Cells (Neutrophils), Platelet Count and Leukocyte Count at End of Study Platelet count at Inclusion Visit	279.7 gram per liter (g/L) Standard Deviation 103.6	261.4 gram per liter (g/L) Standard Deviation 122.9
Change From Inclusion Visit in Disease Status as Measured by Number of Neutrophil Cells (Neutrophils), Platelet Count and Leukocyte Count at End of Study Change in platelet count	-31.9 gram per liter (g/L) Standard Deviation 117.0	-43.4 gram per liter (g/L) Standard Deviation 127.2
Change From Inclusion Visit in Disease Status as Measured by Number of Neutrophil Cells (Neutrophils), Platelet Count and Leukocyte Count at End of Study Leukocyte count at Inclusion Visit	7.6 gram per liter (g/L) Standard Deviation 26.4	6.7 gram per liter (g/L) Standard Deviation 9.4
Change From Inclusion Visit in Disease Status as Measured by Number of Neutrophil Cells (Neutrophils), Platelet Count and Leukocyte Count at End of Study Change in leukocyte count	-0.1 gram per liter (g/L) Standard Deviation 13.3	1.5 gram per liter (g/L) Standard Deviation 17.7

SECONDARY outcome

Timeframe: Inclusion visit (Week 1); End of study visit (up to Week 19)

The Karnofsky performance scale was used for rating participant activities of daily living. The KPS scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities. The lower the Karnofsky score, the worse the survival for most serious illnesses. The score ranges included as 100 (Normal; no complaints), 90 (Able to carry on normal activity), 80 (Normal activity with effort), 70 (Cares for self; unable to carry on normal activity), 60 (Requires occasional assistance, but is able to care), 50 (Requires considerable assistance and frequent medical care), 40 (Disabled; requires special care), 30 (Severely disabled), 20 (Very sick; hospital admission necessary), 10 (Moribund; fatal processes progressing rapidly) and 0 (Dead).

Outcome measures

Outcome measures
Measure	Adjuvant Chemotherapy n=315 Participants Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy n=318 Participants Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Change From Inclusion Visit in Disease Status as Measured by Participants Performance Status at End of Study	-2.7 score on a scale Standard Deviation 11.0	-9.1 score on a scale Standard Deviation 20.7

SECONDARY outcome

Timeframe: Inclusion visit (Week 1), End of study visit (up to Week 19)

Change in the disease status of the participant was measured by the change in the hemoglobin level as reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Adjuvant Chemotherapy n=457 Participants Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy n=493 Participants Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Change From Inclusion Visit in Disease Status as Measured by Haemoglobin Level at End of Study Visit	-1.2 grams per deciliter (g/dl) Standard Deviation 1.6	-0.9 grams per deciliter (g/dl) Standard Deviation 1.7

SECONDARY outcome

Timeframe: End of study visit (up to Week 19)

Pain experienced by participant at the injection site was measured on a scale 0 to 10 (0 = no pain to 10 = maximum pain), where higher score indicates maximum pain.

Outcome measures

Outcome measures
Measure	Adjuvant Chemotherapy n=458 Participants Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy n=469 Participants Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Pain Experienced by Participant During Injection of Nivestim as Assessed by Pain at the Injection Site	2.0 unit on a scale Standard Deviation 2.0	2.0 unit on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: End of study visit (up to Week 19)

Participant's satisfaction after the chemotherapy treatment was assessed by the doctor and was categorized under the 4 categories as very satisfied, satisfied, not very satisfied and dissatisfied.

Outcome measures

Outcome measures
Measure	Adjuvant Chemotherapy n=472 Participants Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy n=478 Participants Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Number of Participants With Chemotherapy Satisfaction as Per Doctor Assessment After Chemotherapy Treatment Very satisfied	158 Participants	113 Participants
Number of Participants With Chemotherapy Satisfaction as Per Doctor Assessment After Chemotherapy Treatment Satisfied	276 Participants	330 Participants
Number of Participants With Chemotherapy Satisfaction as Per Doctor Assessment After Chemotherapy Treatment Not very satisfied	25 Participants	30 Participants
Number of Participants With Chemotherapy Satisfaction as Per Doctor Assessment After Chemotherapy Treatment Dissatisfied	13 Participants	5 Participants

SECONDARY outcome

Timeframe: End of study visit (up to Week 19)

Population: Analysis population included all participants who received at least one dose of Nivestim and did not have a major deviation from the protocol. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure.

Outcome measures

Outcome measures
Measure	Adjuvant Chemotherapy n=460 Participants Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy n=467 Participants Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Number of Participants Who Wished to Again Have Nivestim Treatment If Necessary	424 Participants	428 Participants

SECONDARY outcome

Timeframe: Inclusion visit (Week 1) up to end of study visit (up to Week 19)

Population: The safety population included all participants who received at least one dose of Nivestim during the study.

An adverse event (AE) was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment Emergent Adverse Event (TEAE) was adverse event that started or worsened in severity after Inclusion visit up to end of study visit (up to Week 19). AEs included both serious and non-serious adverse event. If a participant who reported an SAE also reported an AE that was not serious, that would count as 1 participant in the total number of participants reporting AEs.

Outcome measures

Outcome measures
Measure	Adjuvant Chemotherapy n=552 Participants Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy n=608 Participants Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) AEs	80 Participants	68 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	3 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: End of study visit (up to Week 19)

Population: Analysis population included all participants who received at least one dose of Nivestim and did not had a major deviation from the protocol and who did not had any missing importance level for the determining factors for the use of Nivestim. Here, "Overall Number of Participants Analyzed"=number of participants evaluable for this outcome measure.

Classification of participants into three different profiles were established by level of importance of the determining factors for the use of Nivestim and was categorized as profile 1= not applicable, profile 2= relatively unimportant and profile 3 = not important. A multiple correspondence analysis was conducted on the whole analysis population in order to identify possible different patient profiles. None of these profiles could have been associated to a type of chemotherapy (adjuvant or metastatic).

Outcome measures

Outcome measures
Measure	Adjuvant Chemotherapy n=1121 Participants Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Number of Participants in Different Profiles Receiving Treatment With Nivestim Profile 1	475 Participants	—
Number of Participants in Different Profiles Receiving Treatment With Nivestim Profile 2	439 Participants	—
Number of Participants in Different Profiles Receiving Treatment With Nivestim Profile 3	207 Participants	—

Adverse Events

Adjuvant Chemotherapy

Serious events: 3 serious events

Other events: 78 other events

Deaths: 2 deaths

Metastatic Chemotherapy

Serious events: 2 serious events

Other events: 67 other events

Deaths: 41 deaths

Serious adverse events

Serious adverse events
Measure	Adjuvant Chemotherapy n=552 participants at risk Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.	Metastatic Chemotherapy n=608 participants at risk Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
Gastrointestinal disorders Diarrhoea	0.18% 1/552 • Inclusion visit (Week 1) up to end of study visit (up to Week 19) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety population.	0.00% 0/608 • Inclusion visit (Week 1) up to end of study visit (up to Week 19) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/552 • Inclusion visit (Week 1) up to end of study visit (up to Week 19) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety population.	0.16% 1/608 • Inclusion visit (Week 1) up to end of study visit (up to Week 19) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.18% 1/552 • Inclusion visit (Week 1) up to end of study visit (up to Week 19) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety population.	0.00% 0/608 • Inclusion visit (Week 1) up to end of study visit (up to Week 19) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety population.
Infections and infestations Bronchitis	0.18% 1/552 • Inclusion visit (Week 1) up to end of study visit (up to Week 19) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety population.	0.00% 0/608 • Inclusion visit (Week 1) up to end of study visit (up to Week 19) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.18% 1/552 • Inclusion visit (Week 1) up to end of study visit (up to Week 19) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety population.	0.00% 0/608 • Inclusion visit (Week 1) up to end of study visit (up to Week 19) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/552 • Inclusion visit (Week 1) up to end of study visit (up to Week 19) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety population.	0.16% 1/608 • Inclusion visit (Week 1) up to end of study visit (up to Week 19) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety population.

Other adverse events

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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