| Primary | Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim | 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. | 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. | Posted | | Number | | Percentage of participants | | Inclusion visit (Week 1) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Participant sex: Very important (VI) | - ParticipantsOG000547
- ParticipantsOG001595
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| Secondary | Number of Participants Who Continued Chemotherapy | 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. | 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. | Posted | | Count of Participants | | Participants | | Follow-up visit (Week 3); End of study visit ( up to Week 19) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Participants Who Discontinued Chemotherapy | | 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. | Posted | | Count of Participants | | Participants | | Follow-up visit (Week 3); End of study visit ( up to Week 19) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Participants With Unplanned Discontinuation of Chemotherapy at Follow Up Visit | | 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. | Posted | | Count of Participants | | Participants | | Follow-up visit (Week 3) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Participants With Dose Reduction in Chemotherapy Due to Neutropenia | 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. | 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. | Posted | | Count of Participants | | Participants | | Follow-up visit (Week 3) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Participants With Delayed Administration of Chemotherapy Cycle Due to Neutropenia | 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. | 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. | Posted | | Count of Participants | | Participants | | Follow-up visit (Week 3) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Participants With Unplanned Discontinuation of Chemotherapy at the End of Study Visit | 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. | 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. | Posted | | Count of Participants | | Participants | | End of study visit (up to Week 19) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Participants With Change in Chemotherapy Protocol at End of Study Visit | 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. | 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. | Posted | | Count of Participants | | Participants | | End of study visit (up to Week 19) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Participants With Neutropenia and Febrile Neutropenia | 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. | 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. | Posted | | Count of Participants | | Participants | | Follow-up visit (Week 3); End of study visit (up to Week 19) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | 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 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. | 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. | Posted | | Mean | Standard Deviation | gram per liter (g/L) | | Inclusion visit (Week 1), End of study visit (up to Week 19) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Change From Inclusion Visit in Disease Status as Measured by Participants Performance Status at End of Study | 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). | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Inclusion visit (Week 1); End of study visit (up to Week 19) | | | | ID | Title | Description |
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| OG000 | 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. | |
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| Secondary | Change From Inclusion Visit in Disease Status as Measured by Haemoglobin Level at End of Study Visit | Change in the disease status of the participant was measured by the change in the hemoglobin level as reported in this outcome measure. | 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. | Posted | | Mean | Standard Deviation | grams per deciliter (g/dl) | | Inclusion visit (Week 1), End of study visit (up to Week 19) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Pain Experienced by Participant During Injection of Nivestim as Assessed by Pain at the Injection Site | 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. | 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. | Posted | | Mean | Standard Deviation | unit on a scale | | End of study visit (up to Week 19) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Participants With Chemotherapy Satisfaction as Per Doctor Assessment After Chemotherapy Treatment | 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. | 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. | Posted | | Count of Participants | | Participants | | End of study visit (up to Week 19) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Participants Who Wished to Again Have Nivestim Treatment If Necessary | | 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. | Posted | | Count of Participants | | Participants | | End of study visit (up to Week 19) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. | The safety population included all participants who received at least one dose of Nivestim during the study. | Posted | | Count of Participants | | Participants | | Inclusion visit (Week 1) up to end of study visit (up to Week 19) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Metastatic Chemotherapy |
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| Other Pre-specified | Number of Participants in Different Profiles Receiving Treatment With Nivestim | 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). | 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. | Posted | | Count of Participants | | Participants | | End of study visit (up to Week 19) | | | | ID | Title | Description |
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| OG000 | Adjuvant or Metastatic Chemotherapy | 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. |
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