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

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)

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.

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)

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.

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)

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.

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)

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.

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)

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.

Time frame: 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.

Time frame: 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.

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)

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.

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)

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.

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)

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.

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)

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.

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)

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.

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)

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

Time frame: 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.

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)

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.

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)

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.

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)

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.