VISTA: Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02454530
• Collaborator: Hospira, now a wholly owned subsidiary of Pfizer (Industry)
• Enrollment: 1,160
• Locations: 92
• Actual Duration (Months): 28
• Patients Per Site: 12.6
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The aim of this study is to describe in real-life conditions the determinants of use of GCSF (Granulocyte Colony-Stimulating Factor) Nivestim® in primary or secondary prophylaxis and in patients receiving chemotherapy for solid tumour according to the chemotherapy context: adjuvant or metastatic setting.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy-Induced Neutropenia	Biological: Nivestim®

Detailed Description

This is a longitudinal, observational, prospective, multicentre, cohort study, conducted in France among a representative sample of public and/or private hospital-based oncologists.

Data will be collected by the investigator during three visits using data available in the patient medical record and obtained from patient questioning and clinical examination performed during the consultations:

• Baseline visit: prescription of Nivestim®.

• Follow-up visit: during the first cycle of chemotherapy after the first course of Nivestim®.

• Final visit: after the last cycle of chemotherapy or 16-18 weeks after inclusion.

Study Design

• Study Type: Observational
• Actual Enrollment: 1160 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: PROPHYLACTIC TREATMENT FOR CHEMO-INDUCED NEUTROPENIA. USE OF G-CSF BIOSIMILAR (NIVESTIM(REGISTERED)) ACCORDING TO THE CHEMOTHERAPY CONTEXT: ADJUVANT VERSUS METASTATIC.
• Actual Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Oct 18, 2016
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Cancer patients treated with Nivestim®	Biological: Nivestim®

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim [Inclusion visit (Week 1)]

   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.

Secondary Outcome Measures

1. Number of Participants Who Continued Chemotherapy [Follow-up visit (Week 3); End of study visit ( up to Week 19)]

   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.

2. Number of Participants Who Discontinued Chemotherapy [Follow-up visit (Week 3); End of study visit ( up to Week 19)]

3. Number of Participants With Unplanned Discontinuation of Chemotherapy at Follow Up Visit [Follow-up visit (Week 3)]

4. Number of Participants With Dose Reduction in Chemotherapy Due to Neutropenia [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.

5. Number of Participants With Delayed Administration of Chemotherapy Cycle Due to Neutropenia [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.

6. Number of Participants With Unplanned Discontinuation of Chemotherapy at the End of Study Visit [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.

7. Number of Participants With Change in Chemotherapy Protocol at End of Study Visit [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.

8. Number of Participants With Neutropenia and Febrile Neutropenia [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.

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 [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.

10. Change From Inclusion Visit in Disease Status as Measured by Participants Performance Status at End of Study [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).

11. Change From Inclusion Visit in Disease Status as Measured by Haemoglobin Level at End of Study Visit [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.

12. Pain Experienced by Participant During Injection of Nivestim as Assessed by Pain at the Injection Site [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.

13. Number of Participants With Chemotherapy Satisfaction as Per Doctor Assessment After Chemotherapy Treatment [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.

14. Number of Participants Who Wished to Again Have Nivestim Treatment If Necessary [End of study visit (up to Week 19)]

15. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Inclusion visit (Week 1) up to end of study visit (up to Week 19)]

    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.

Other Outcome Measures

1. Number of Participants in Different Profiles Receiving Treatment With Nivestim [End of study visit (up to Week 19)]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients aged at least 18 years, seen by the oncologist for chemotherapy for solid tumour.

• Patients for whom the oncologist has decided the initiation of G-CSF biosimilar treatment (Nivestim®) in primary or secondary prophylaxis.

• Patients informed about the computer processing of their medical data and their right of access and correction.

Exclusion Criteria:

• Patients with contraindication of use of Nivestim®.

• Patients with haematological malignancy including Myelodysplasia and Chronic myeloid leukemia treated or untreated.

• Patients participating or having participated in the previous month in a clinical trial.

• Patients refusing to participate in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique Rambot La Provençale Tour d'Aygosi	Aix En Provence		France	13100
2	Centre Hospitalier du Pays d'Aix Service d'Hématologie - Oncologie	Aix En Provence		France	13616
3	CHU - Hôtel-Dieu Service Hépato-Gastro-entérologie	Angers Cedex 9		France	49933
4	ICO Centre Paul Papin Service d'Oncologie Médicale	Angers		France	49000
5	CH d'Armentières Service Oncologie	Armentieres		France	59280
6	Centre Marie Curie A l'attention de Laëtitia	Arras Cedex		France	62000
7	Centre Hospitalier Service Oncologie	Auxerre Cedex		France	89011
8	Hôpital de Falconaja Furiani Service d'Oncologie	Bastia Cedex		France	20604
9	Clinique du Dr Maymard Service d'Oncologie	Bastia		France	20200
10	Centre Hospitalier Philippe le Bon Service de Medecine Interne - 3e Etage	Beaune		France	21200
11	CHU - Hôpital Jean Minjoz Service Oncologie Médicale	Besancon Cedex		France	25030
12	Centre Hospitalier Service Onco-Hématologie	Beziers Cedex		France	34525
13	Hôpital Avicenne Service Gastro-Entérologie	Bobigny Cedex		France	93009
14	Clinique Tivoli	Bordeaux Cedex		France	BP 114 33030
15	Centre Hospitalier Service d'Oncologie	Boulogne Sur Mer Cedex		France	62321
16	CH de Fleyriat Service de Pneumologie	Bourg En Bresse		France	CS 90401 01012
17	CH de Fleyriat Service Onco-Hématologie	Bourg En Bresse		France	CS 90401 01012
18	Hôpital Augustin Morvan Institut de Cancérologie et d'Hématologie	Brest Cedex 2		France	29609
19	Hôpital Morvan - CHU Institut de Cancérologie et d'Hématologie	Brest Cedex		France	29609
20	Clinique Pasteur Lanroze Service Oncologie	Brest		France	29200
21	Hôpital Louis Pradel Service Pneumologie - Centre des Maladies Orphelines	Bron Cedex		France	69677
22	Centre François Baclesse Oncologie Médicale. Pathologie Mammaire et Recherche Clinique	Caen Cedex 5		France	14076
23	Centre Hospitalier de Carcassonne Service d'Oncologie	Carcassonne Cedex 9		France	11890
24	Centre Hospitalier Service d'Oncologie	Carcassonne Cedex		France	11010
25	Medipole de Savoie Service Oncologie	Challes Les Eaux		France	73190
26	Médipole de Savoie	Challes Les Eaux		France	73190
27	CH William Morey Service d'Oncologie Médicale	Chalon Sur Saone Cedex		France	71321
28	CHP du Cotentin - Site de Cherbourg Service d'Oncologie	Cherbourg		France	50100
29	Centre Hospitalier de Cholet Service d' Oncologie Médicale	Cholet Cedex		France	49325
30	Centre Hospitalier de Cholet Service d'Hepato-Gastro-Enterologie	Cholet		France	49325
31	Centre hospitalier Louis Pasteur Service de Pneumologie	Colmar Cedex		France	68024
32	Hôpital Louis Pasteur Service de Pneumologie - Médecine F	Colmar Cedex		France	68024
33	Centre de Radiothérapie GIE CROM	Compiegne		France	60204
34	CHU de Dijon - Hôpital du Bocage Service Hépato-Gastro-Entérologie	Dijon Cedex		France	BP 77908 21079
35	Centre Hospitalier de la Dracénie Service d'Oncologie	Draguignan		France	BP 249 83007
36	Centre Hospitalier de la Dracénie Service d'Oncologie	Draguignan		France	BP 249 83300
37	Centre Hospitalier Emile Durkheim Service Oncologie	Epinal Cedex		France	88021
38	Clinique Chirurgicale Pasteur Service Oncologie Médicale	Evreux Cedex		France	27025
39	CHI Fréjus Saint Raphaël Service d'Oncologie Médicale	Frejus		France	83608
40	CHI des Alpes du sud Site de Gap Muret Hôpital de Jour - Oncologie	GAP		France	05007
41	Centre Hospitalier Service d'Oncologie	Gonesse Cedex		France	BP 30071 95503
42	Centre Hospitalier Service Onco-Hématologie	Le Mans		France	72000
43	Clinique Hartman Service de Radiothérapie	Levallois Perret Cedex		France	92309
44	Clinique Hartmann Service Oncologie	Levallois Perret Cedex		France	92309
45	Centre de Radiothérapie Hartmann	Levallois Perret Cedex		France	CS 90004 92309
46	Centre de Radiothérapie Hartmann	Levallois Perret		France	92300
47	Institut Franco Britannique Service Oncologie Médicale	Levallois Perret		France	92300
48	CHRU Lille - Hôpital Huriez Unité d'Oncologie Médicale	Lille Cedex		France	59037
49	CHU Dupuytren Limoges Service d'Oncologie	Limoges		France	87042
50	Centre Hospitalier Service de Médecine 2 - Hôpital de jour	Lons le Saunier Cedex		France	39000
51	CH Saint-Joseph et Saint-Luc Service de Gastro-Entérologie	Lyon Cedez 07		France	69365
52	Centre Léon Bérard Service d'Oncologie Médicale	Lyon		France	69008
53	Hôpital Privé Jean Mermoz Service d'Oncologie Médicale	Lyon		France	69008
54	Hôpital Nord Service d'Oncologie Multidisciplinaires et Innovations Thérapeutiques	Marseille Cedex 20		France	13915
55	Centre Hospitalier Privé Clairval Service de Cancérologie	Marseille		France	13009
56	Clinique Claude Bernard Service de Chimiothérapie	Metz Cedex 03		France	57072
57	Clinique Claude Bernard Service Chimiothérapie	Metz Cedex 03		France	BP 45050 57072
58	Centre Hospitalier Layne Service d'Oncologie	Mont de Marsan Cedex		France	40024
59	Centre Hospitalier de Belfort-Montbéliard Site du Mittan-Oncologie et radiothérapie	Montbeliard		France	25200
60	CHU Montpellier - Hôpital Arnaud de Villeneuve Service de Cancérologie	Montpellier Cedex 5		France	34295
61	Clinique Clementville Service d'Oncologie	Montpellier		France	34000
62	Centre Hospitalier Emile Muller	Mulhouse Cedex		France	68070
63	CH de Mulhouse - Hôpital Emile Muller Hôpital de Jour - Oncologie	Mulhouse Cedex		France	68070
64	Polyclinique de Gentilly Service Oncologie Médicale	Nancy		France	54100
65	CHU - Hôpital Hôtel Dieu Unité de Gastroentérologie	Nantes Cedex 1		France	44093
66	CHU de Nantes - Hôpital Laënnec Service d'Oncologie Médicale	Nantes		France	44093
67	Centre Hospitalier de Narbonne Oncologie / Hématologie	Narbonne		France	11108
68	Hôpital Américain	Neuilly Sur Seine		France	92200
69	Hôpital Bichat Claude Bernard Service Hépato-Gastroentérologie et Cancérologie Digestive	Paris Cedex 18		France	75877
70	Hôpital Tenon Service d'oncologie médicale	Paris Cedex 20		France	75970
71	Institut Mutualiste Montsouris Service Oncologie Médicale	Paris		France	75014
72	Clinique Alleray Labrouste Service d'Oncologie Médicale	Paris		France	75015
73	Hôpital Européen Georges Pompidou Service d'Oncologie Médicale	Paris		France	75015
74	Hôpital Européen Georges Pompidou Service Oncologie Médicale - 4e étage (ascenseur B)	Paris		France	75015
75	Centre Hospitalier Service d'Oncologie	Perpignan		France	66046
76	Centre Hospitalier Service de Pneumologie	Perpignan		France	BP 4052 66046
77	Centre Hospitalier Annecy Genevois Service Pneumologie	Pringy Cedex		France	74370
78	Centre Hospitalier de la region d'Annecy Pole Medecine	Pringy Cedex		France	METZ TESSY 74374
79	CH de Cornouaille Service d'Oncologie Médicale	Quimper Cedex		France	29107
80	Institut Jean Godinot	Reims Cedex		France	51726
81	Clinique de l'Europe Unité d'Oncologie	Rouen		France	76100
82	Hôpital de Saint-Avold Service Oncologie II	Saint Avold Cedex		France	57502
83	Centre Hospitalier Privé Saint Grégoire Service d'Oncologie - Radiothérapie	Saint Gregoire		France	35760
84	Centre Hospitalier Privé Saint-Grégoire Service d'Oncologie - Radiothérapie	Saint Gregoire		France	35760
85	Clinique François 1er	Saint-dizier		France	52100
86	Centre Clinical Service d'Oncologie-Radiothérapie	Soyaux		France	16800
87	Centre de Radiothérapie SCP Strasbourg Oncologie Libérale	Strasbourg Cedex		France	67085
88	Hôpital de Thionville Service Oncologie Médicale	Thionville Cedex		France	BP 60327 57126
89	Hôpital Bel Air Service Pneumologie	Thionville		France	57312
90	Clinique Pasteur	Toulouse Cedex 3		France	BP 27617 31076
91	Hôpital Rangueil Service d'Oncologie Médicale Digestive et Gynécologique	Toulouse		France	31059
92	Hôpital Bretonneau Service d'Oncologie Médicale	Tours Cedex 9		France	37044

Sponsors and Collaborators

• Pfizer
• Hospira, now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02454530
• Other Study ID Numbers: VISTA; C1121007
• First Posted: May 27, 2015
• Last Update Posted: Jun 28, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Neutropenia

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Adjuvant Chemotherapy	Metastatic Chemotherapy
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	552	608
COMPLETED	482	481
NOT COMPLETED	70	127

Baseline Characteristics

Arm/Group Title	Adjuvant Chemotherapy	Metastatic Chemotherapy	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	551	603	1154
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.3 (12.1)	65.0 (11.0)	62.7 (11.8)
Sex/Gender, Customized (Count of Participants)
Female	399 72.4%	324 53.7%	723 62.7%
Male	149 27%	277 45.9%	426 36.9%
Missing	3 0.5%	2 0.3%	5 0.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim
Description	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.
Time Frame	Inclusion visit (Week 1)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adjuvant Chemotherapy	Metastatic Chemotherapy
Arm/Group Description	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.	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.
Measure Participants	551	603
Participant sex: Very important (VI)	2.7 0.5%	1.7 0.3%
Participant sex: Important	11.2 2%	7.2 1.2%
Participant sex: Relatively unimportant (RU)	24.5 4.4%	22.5 3.7%
Participant sex: Not important (NI)	52.3 9.5%	58.2 9.7%
Participant sex: Not applicable (NA)	9.3 1.7%	10.4 1.7%
Young participant: VI	4.6 0.8%	2.7 0.4%
Young participant: Important	17.2 3.1%	9.3 1.5%
Young participant: RU	26.5 4.8%	26.8 4.4%
Young participant: NI	24.5 4.4%	27.1 4.5%
Young participant: NA	27.2 4.9%	34.2 5.7%
Elderly participant: VI	22.3 4%	20.8 3.4%
Elderly participant: Important	30.6 5.6%	33.9 5.6%
Elderly Participant: RU	12.9 2.3%	13.3 2.2%
Elderly participant: NI	12.7 2.3%	14.4 2.4%
Elderly participant: NA	21.5 3.9%	17.6 2.9%
Past history of infection: VI	16.7 3%	15.6 2.6%
Past history of infection: Important	22.5 4.1%	25.7 4.3%
Past history of infection: RU	11.2 2%	13.8 2.3%
Past history of infection: NI	17.2 3.1%	17.6 2.9%
Past history of infection: NA	32.4 5.9%	27.2 4.5%
Comorbidities: VI	19.6 3.6%	20.4 3.4%
Comorbidities: Important	27.8 5%	32.8 5.4%
Comorbidities: RU	15.6 2.8%	15.0 2.5%
Comorbidities: NI	15.4 2.8%	15.7 2.6%
Comorbidities: NA	21.6 3.9%	16.2 2.7%
Life expectancy: VI	23.1 4.2%	15.5 2.6%
Life expectancy: Important	26.4 4.8%	31.4 5.2%
Life expectancy: RU	18.5 3.4%	24.8 4.1%
Life expectancy: NI	14.5 2.6%	15.2 2.5%
Life expectancy: NA	17.4 3.2%	13.2 2.2%
Past history febrile neutropenia (FN): VI	29.9 5.4%	29.7 4.9%
Past history FN: Important	7.5 1.4%	12.2 2%
Past history FN: RU	7.1 1.3%	7.0 1.2%
Past history FN: NI	13.9 2.5%	13.8 2.3%
Past history FN: NA	41.6 7.5%	37.2 6.2%
Past history of severe neutropenia (SN): VI	26.9 4.9%	29.3 4.9%
Past history of SN: Important	16.1 2.9%	19.2 3.2%
Past history of SN: RU	8.2 1.5%	8.9 1.5%
Past history of SN: NI	11.9 2.2%	10.9 1.8%
Past history of SN: NA	36.9 6.7%	31.6 5.2%
Occupational activity: VI	2.6 0.5%	1.8 0.3%
Occupational activity: Important	8.4 1.5%	7.9 1.3%
Occupational activity: RU	28.0 5.1%	22.4 3.7%
Occupational activity:NI	26.6 4.8%	29.4 4.9%
Occupational activity: NA	34.4 6.2%	38.5 6.4%
Family activity: VI	2.9 0.5%	1.0 0.2%
Family activity: Important	15.2 2.8%	13.0 2.2%
Family activity: RU	22.4 4.1%	18.5 3.1%
Family activity: NI	26.4 4.8%	28.8 4.8%
Family activity: NA	33.0 6%	38.6 6.4%
Other VI/ Important criteria	17.2 3.1%	21.4 3.5%

2. Secondary Outcome

Title	Number of Participants Who Continued Chemotherapy
Description	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.
Time Frame	Follow-up visit (Week 3); End of study visit ( up to Week 19)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adjuvant Chemotherapy	Metastatic Chemotherapy
Arm/Group Description	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.	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.
Measure Participants	551	603
Follow up visit	514 93.3%	524 86.9%
End of study visit	111 20.1%	202 33.5%

3. Secondary Outcome

Title	Number of Participants Who Discontinued Chemotherapy
Time Frame	Follow-up visit (Week 3); End of study visit ( up to Week 19)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adjuvant Chemotherapy	Metastatic Chemotherapy
Arm/Group Description	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.	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.
Measure Participants	551	603
Follow up visit	22 4%	42 7%
End of study visit	482 87.5%	502 83.3%

4. Secondary Outcome

Title	Number of Participants With Unplanned Discontinuation of Chemotherapy at Follow Up Visit
Time Frame	Follow-up visit (Week 3)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adjuvant Chemotherapy	Metastatic Chemotherapy
Arm/Group Description	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.	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.
Measure Participants	22	42
Count of Participants [Participants]	10 1.8%	36 6%

5. Secondary Outcome

Title	Number of Participants With Dose Reduction in Chemotherapy Due to Neutropenia
Description	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.
Time Frame	Follow-up visit (Week 3)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adjuvant Chemotherapy	Metastatic Chemotherapy
Arm/Group Description	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.	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.
Measure Participants	12	15
Count of Participants [Participants]	0 0%	1 0.2%

6. Secondary Outcome

Title	Number of Participants With Delayed Administration of Chemotherapy Cycle Due to Neutropenia
Description	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.
Time Frame	Follow-up visit (Week 3)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adjuvant Chemotherapy	Metastatic Chemotherapy
Arm/Group Description	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.	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.
Measure Participants	12	15
Count of Participants [Participants]	1 0.2%	0 0%

7. Secondary Outcome

Title	Number of Participants With Unplanned Discontinuation of Chemotherapy at the End of Study Visit
Description	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.
Time Frame	End of study visit (up to Week 19)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adjuvant Chemotherapy	Metastatic Chemotherapy
Arm/Group Description	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.	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.
Measure Participants	482	502
Count of Participants [Participants]	39 7.1%	136 22.6%

8. Secondary Outcome

Title	Number of Participants With Change in Chemotherapy Protocol at End of Study Visit
Description	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.
Time Frame	End of study visit (up to Week 19)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adjuvant Chemotherapy	Metastatic Chemotherapy
Arm/Group Description	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.	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.
Measure Participants	86	118
Neutropenia	21 3.8%	21 3.5%
Febrile neutropenia	2 0.4%	2 0.3%
Other toxicity	57 10.3%	89 14.8%
Neutropenia/Febrile neutropenia	2 0.4%	0 0%
Neutropenia/Other toxicity	2 0.4%	6 1%
Febrile neutropenia/Other toxicity	2 0.4%	0 0%

9. Secondary Outcome

Title	Number of Participants With Neutropenia and Febrile Neutropenia
Description	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.
Time Frame	Follow-up visit (Week 3); End of study visit (up to Week 19)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adjuvant Chemotherapy	Metastatic Chemotherapy
Arm/Group Description	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.	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.
Measure Participants	551	603
Follow up visit: Febrile Neutropenia	21 3.8%	19 3.2%
Follow up visit: Neutropenia	21 3.8%	21 3.5%
Final visit: Febrile Neutropenia	9 1.6%	16 2.7%
Final visit: Neutropenia	63 11.4%	75 12.4%

10. Secondary Outcome

Title	Change From Inclusion Visit in Disease Status as Measured by Number of Neutrophil Cells (Neutrophils), Platelet Count and Leukocyte Count at End of Study
Description	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.
Time Frame	Inclusion visit (Week 1), End of study visit (up to Week 19)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adjuvant Chemotherapy	Metastatic Chemotherapy
Arm/Group Description	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.	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.
Measure Participants	551	603
NP count at Inclusion Visit	4.6 (15.4)	5.3 (16.9)
Change in NP count	-0.2 (10.9)	1.8 (33.2)
Platelet count at Inclusion Visit	279.7 (103.6)	261.4 (122.9)
Change in platelet count	-31.9 (117.0)	-43.4 (127.2)
Leukocyte count at Inclusion Visit	7.6 (26.4)	6.7 (9.4)
Change in leukocyte count	-0.1 (13.3)	1.5 (17.7)

11. Secondary Outcome

Title	Change From Inclusion Visit in Disease Status as Measured by Participants Performance Status at End of Study
Description	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).
Time Frame	Inclusion visit (Week 1); End of study visit (up to Week 19)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adjuvant Chemotherapy	Metastatic Chemotherapy
Arm/Group Description	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.	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.
Measure Participants	315	318
Mean (Standard Deviation) [score on a scale]	-2.7 (11.0)	-9.1 (20.7)

12. Secondary Outcome

Title	Change From Inclusion Visit in Disease Status as Measured by Haemoglobin Level at End of Study Visit
Description	Change in the disease status of the participant was measured by the change in the hemoglobin level as reported in this outcome measure.
Time Frame	Inclusion visit (Week 1), End of study visit (up to Week 19)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adjuvant Chemotherapy	Metastatic Chemotherapy
Arm/Group Description	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.	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.
Measure Participants	457	493
Mean (Standard Deviation) [grams per deciliter (g/dl)]	-1.2 (1.6)	-0.9 (1.7)

13. Secondary Outcome

Title	Pain Experienced by Participant During Injection of Nivestim as Assessed by Pain at the Injection Site
Description	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.
Time Frame	End of study visit (up to Week 19)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adjuvant Chemotherapy	Metastatic Chemotherapy
Arm/Group Description	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.	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.
Measure Participants	458	469
Mean (Standard Deviation) [unit on a scale]	2.0 (2.0)	2.0 (2.0)

14. Secondary Outcome

Title	Number of Participants With Chemotherapy Satisfaction as Per Doctor Assessment After Chemotherapy Treatment
Description	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.
Time Frame	End of study visit (up to Week 19)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adjuvant Chemotherapy	Metastatic Chemotherapy
Arm/Group Description	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.	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.
Measure Participants	472	478
Very satisfied	158 28.7%	113 18.7%
Satisfied	276 50.1%	330 54.7%
Not very satisfied	25 4.5%	30 5%
Dissatisfied	13 2.4%	5 0.8%

15. Secondary Outcome

Title	Number of Participants Who Wished to Again Have Nivestim Treatment If Necessary
Time Frame	End of study visit (up to Week 19)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adjuvant Chemotherapy	Metastatic Chemotherapy
Arm/Group Description	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.	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.
Measure Participants	460	467
Count of Participants [Participants]	424 77%	428 71%

16. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description	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.
Time Frame	Inclusion visit (Week 1) up to end of study visit (up to Week 19)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Adjuvant Chemotherapy	Metastatic Chemotherapy
Arm/Group Description	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.	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.
Measure Participants	552	608
AEs	80 14.5%	68 11.3%
SAEs	3 0.5%	2 0.3%

17. Other Pre-specified Outcome

Title	Number of Participants in Different Profiles Receiving Treatment With Nivestim
Description	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).
Time Frame	End of study visit (up to Week 19)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adjuvant or Metastatic Chemotherapy
Arm/Group Description	Participants with previous solid tumour who were prescribed Nivestim at the inclusion visit (Week 1), and were receiving adjuvant or metastatic type of chemotherapy after first course of Nivestim (maximum duration was 15 days for adjuvant chemotherapy and 10 days for metastatic chemotherapy) were observed for a maximum of 2.25 years in this study.
Measure Participants	1121
Profile 1	475 86.2%
Profile 2	439 79.7%
Profile 3	207 37.6%

Adverse Events

Time Frame	Inclusion visit (Week 1) up to end of study visit (up to Week 19)
Adverse Event Reporting Description	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.
Arm/Group Title	Adjuvant Chemotherapy		Metastatic Chemotherapy
Arm/Group Description	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.		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.
All Cause Mortality
	Adjuvant Chemotherapy		Metastatic Chemotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/552 (0.4%)		41/608 (6.7%)
Serious Adverse Events
	Adjuvant Chemotherapy		Metastatic Chemotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/552 (0.5%)		2/608 (0.3%)
Gastrointestinal disorders
Diarrhoea	1/552 (0.2%)		0/608 (0%)
Infections and infestations
Bronchitis	1/552 (0.2%)		0/608 (0%)
Musculoskeletal and connective tissue disorders
Musculoskeletal pain	1/552 (0.2%)		0/608 (0%)
Respiratory, thoracic and mediastinal disorders
Lung infiltration	0/552 (0%)		1/608 (0.2%)
Lung disorder	1/552 (0.2%)		0/608 (0%)
Pulmonary embolism	0/552 (0%)		1/608 (0.2%)
Other (Not Including Serious) Adverse Events
	Adjuvant Chemotherapy		Metastatic Chemotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	78/552 (14.1%)		67/608 (11%)
Blood and lymphatic system disorders
Hyperleukocytosis	3/552 (0.5%)		1/608 (0.2%)
Thrombocytopenia	1/552 (0.2%)		2/608 (0.3%)
Anaemia	2/552 (0.4%)		7/608 (1.2%)
Febrile neutropenia	0/552 (0%)		1/608 (0.2%)
Neutropenia	2/552 (0.4%)		0/608 (0%)
Ear and labyrinth disorders
Vertigo	0/552 (0%)		1/608 (0.2%)
Gastrointestinal disorders
Nausea	11/552 (2%)		10/608 (1.6%)
Vomiting	3/552 (0.5%)		4/608 (0.7%)
Constipation	2/552 (0.4%)		3/608 (0.5%)
Diarrhoea	4/552 (0.7%)		7/608 (1.2%)
Anorexia	1/552 (0.2%)		3/608 (0.5%)
Mucite	2/552 (0.4%)		5/608 (0.8%)
Abdominal discomfort	0/552 (0%)		1/608 (0.2%)
Abdominal pain	1/552 (0.2%)		2/608 (0.3%)
Gastroesophageal reflux	0/552 (0%)		1/608 (0.2%)
General disorders
General physical health deterioration	13/552 (2.4%)		6/608 (1%)
Injection site pain	2/552 (0.4%)		0/608 (0%)
Allergic reaction	1/552 (0.2%)		0/608 (0%)
Asthenia	1/552 (0.2%)		4/608 (0.7%)
Fatigue	0/552 (0%)		1/608 (0.2%)
Malaise	0/552 (0%)		1/608 (0.2%)
Hepatobiliary disorders
Gamma-glutamyltransferase increased	0/552 (0%)		2/608 (0.3%)
Investigations
Weight decreased	0/552 (0%)		1/608 (0.2%)
Metabolism and nutrition disorders
Alkaline phosphatase increased	0/552 (0%)		2/608 (0.3%)
Musculoskeletal and connective tissue disorders
Chest pain	5/552 (0.9%)		4/608 (0.7%)
Musculoskeletal pain	44/552 (8%)		29/608 (4.8%)
Back pain	1/552 (0.2%)		0/608 (0%)
Bone pain	1/552 (0.2%)		2/608 (0.3%)
Muscle spasms	0/552 (0%)		2/608 (0.3%)
Muscular weakness	1/552 (0.2%)		0/608 (0%)
Myalgia	1/552 (0.2%)		1/608 (0.2%)
Nervous system disorders
Headache	4/552 (0.7%)		3/608 (0.5%)
Renal and urinary disorders
Urinary track disorder	1/552 (0.2%)		0/608 (0%)
Reproductive system and breast disorders
Metrorrhagia	1/552 (0.2%)		0/608 (0%)
Pelvic pain	1/552 (0.2%)		0/608 (0%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	2/552 (0.4%)		1/608 (0.2%)
Cough	2/552 (0.4%)		0/608 (0%)
Skin and subcutaneous tissue disorders
Alopecia	5/552 (0.9%)		5/608 (0.8%)
Rash	0/552 (0%)		1/608 (0.2%)
Eruption	0/552 (0%)		1/608 (0.2%)
Vascular disorders
Hot flush	1/552 (0.2%)		0/608 (0%)
Hypotension	1/552 (0.2%)		0/608 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.