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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004532-58 | EudraCT Number |
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| Name | Class |
|---|---|
| Sandoz GmbH | INDUSTRY |
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The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
This randomized, double-blind trial compared the proposed biosimilar LA-EP2006 with the reference Neulasta® in women (≥18 years) receiving chemotherapy for breast cancer. Therefore patients were randomized to receive LA-EP2006 (n = 159) or the reference product (n = 157) for ≤6 cycles of (neo)-adjuvant TAC (docetaxel 75mg/m^2, doxorubicin 50 mg/m^2, and cyclophosphamide 500mg/m^2) chemotherapy. The primary end point was the duration of severe neutropenia (DSN) during Cycle 1 (defined as number of consecutive days with absolute neutrophil count <0.5 × 10^9/l). The equivalence was confirmed if 95% CIs were within a ±1 day margin. LA-EP2006 was equivalent to the reference product in DSN (difference: 0.07 days; 95% CI [-0.12, 0.26]). Further, LA-EP2006 and the reference Neulasta® showed no clinically meaningful differences regarding efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neulasta® | Active Comparator | During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application. |
|
| LA-EP2006 | Experimental | During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LA-EP2006 | Drug | Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy | Mean duration of severe neutropenia, defined as number of consecutive days with ANC <0.5 × 10^9 cells/L (grade 4 neutropenia). | 21 days (Cycle 1 of chemotherapy treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Febrile Neutropenia (FN) | FN was defined as an oral temperature ≥ 38.3°C while having an absolute neutrophil count (ANC) < 0.5 × 10^9 cells/L. Serious treatment-emergent adverse events (TEAEs) were reconciled with the fever and ANC results recorded in the patient diary and CRF and therefore only the serious TEAEs of FN ("febrile neutropenia", "neutropenic sepsis") were taken into account. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Sandoz Biopharmaceutical Clinical Development | Sandoz | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandoz Investigational Site | Ijuí | 98700-000 | Brazil | |||
| Sandoz Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27020170 | Result | Harbeck N, Lipatov O, Frolova M, Udovitsa D, Topuzov E, Ganea-Motan DE, Nakov R, Singh P, Rudy A, Blackwell K. Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. Future Oncol. 2016 Jun;12(11):1359-67. doi: 10.2217/fon-2016-0016. Epub 2016 Mar 29. | |
| 28637287 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | LA-EP2006 | During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application. LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Neulasta® | Drug | Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application. |
|
|
| across all cycles (18 weeks) |
| Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles | Fever was defined as an oral temperature ≥ 38.3°C. Fever episodes were characterized by maximum oral temperature and the number of patients who had fever at least once. | across al cycles (18 weeks) |
| Depth of ANC Nadir in Cycle 1 | The depth of ANC nadir was defined as the patient's lowest ANC (10^9 cells/L) in Cycle 1. Only the evaluable patients with a depth of ANC in Cycle 1 are given. | Cycle 1 (3 weeks) |
| Number of Patients With ANC Nadir Per Day in Cycle 1 | Numbers of patients with ANC nadir based per day during Cycle 1 are given. | Cycle 1 (3 weeks) |
| Time to ANC Recovery in Days in Cycle 1 | Time to absolute neutrophil count (ANC) recovery in Cycle 1 was defined as the time in days from ANC nadir until the patient's ANC had increased to ≥ 2 × 10^9 cells/L. Only the evaluable patients with a depth of ANC in Cycle 1 and a later increase of ANC ≥ 2 × 10^9 cells/L are given. | across Cycle 1 (3 weeks) |
| Frequency of Infections by Cycle and Across All Cycles | The number of patients with infections was recorded for each cycle and across all cycles. Infections were identified by the AE documentation page selecting all events coded with System Organ Class "Infections and Infestations". | across all cycles (18 weeks) |
| Mortality Due to Infection | Number of patients with death due to infections | Study course (41 weeks) |
| Lajeado |
| 95900-000 |
| Brazil |
| Sandoz Investigational Site | Santo André | 0960-650 | Brazil |
| Sandoz Investigational Site | Andhra Pradesh | 530002 | India |
| Sandoz Investigational Site | Delhi | 110095 | India |
| Sandoz Investigational Site | Madurai | 625107 | India |
| Sandoz Investigational Site | Maharashtra | 411001 | India |
| Sandoz Investigational Site | Maharashtra | 416008 | India |
| Sandoz Investigational Site | Maharashtra | 440010 | India |
| Sandoz Investigational Site | Mumbai | 422005 | India |
| Sandoz Investigational Site | Rajasthan | 302013 | India |
| Sandoz Investigational Site | Aguascalientes | 20230 | Mexico |
| Sandoz Investigational Site | Juchitán | 70000 | Mexico |
| Sandoz Investigational Site | Bucharest | 11461 | Romania |
| Sandoz Investigational Site | Bucharest | 23423 | Romania |
| Sandoz Investigational Site | Iași | 700106 | Romania |
| Sandoz Investigational Site | Suceava | 720237 | Romania |
| Sandoz Investigational Site | Barnaul | 656052 | Russia |
| Sandoz Investigational Site | Bashkortostan | 450054 | Russia |
| Sandoz Investigational Site | Berdsk | 633004 | Russia |
| Sandoz Investigational Site | Ivanovo | 153040 | Russia |
| Sandoz Investigational Site | Kabardino | 361045 | Russia |
| Sandoz Investigational Site | Kazan' | 420029 | Russia |
| Sandoz Investigational Site | Krasnodar | 354057 | Russia |
| Sandoz Investigational Site | Kursk | 305035 | Russia |
| Sandoz Investigational Site | Moscow | 115478 | Russia |
| Sandoz Investigational Site | Oktyabrskaya | 355047 | Russia |
| Sandoz Investigational Site | Ryazan | 390011 | Russia |
| Sandoz Investigational Site | Saint Petersburg | 188663 | Russia |
| Sandoz Investigational Site | Saint Petersburg | 195067 | Russia |
| Sandoz Investigational Site | Tula | 300053 | Russia |
| Sandoz Investigational Site | Veliky Novgorod | 173016 | Russia |
| Sandoz Investigational Site | Cherkasy | 18009 | Ukraine |
| Sandoz Investigational Site | Chernivtsi | 58013 | Ukraine |
| Sandoz Investigational Site | Dnipropetrovsk | 49102 | Ukraine |
| Sandoz Investigational Site | Kharkiv | 61176 | Ukraine |
| Sandoz Investigational Site | Kryvyi Rih | 50048 | Ukraine |
| Sandoz Investigational Site | Luhansk | 91000 | Ukraine |
| Sandoz Investigational Site | Mariupol | 87500 | Ukraine |
| Sandoz Investigational Site | Vinnytsia | 21029 | Ukraine |
| Sandoz Investigational Site | Zaporizhzhia | 69040 | Ukraine |
| Blackwell K, Gascon P, Jones CM, Nixon A, Krendyukov A, Nakov R, Li Y, Harbeck N. Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. Ann Oncol. 2017 Sep 1;28(9):2272-2277. doi: 10.1093/annonc/mdx303. |
| Neulasta® |
During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application. Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application. |
| Completed All Cycles |
|
| Completed All Treatments as Planned |
|
| Completed the 6-month SFU Visit | 1 more patient, LA-EP06 arm died due to disease progression, not included in participant flow-death |
|
| COMPLETED | Completed the study as planned (prior to Safety follow-up) |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LA-EP2006 | During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application. LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application. |
| BG001 | Neulasta® | During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application. Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | More than one race patients (n = 6) were of Mestizo or Parda origin. | Count of Participants | Participants |
| |||||||||||||||
| BMI | BMI is missing for 1 patient allocated to Neulasta® | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Time since diagnosis | For 4 patients in the LA-EP2006 treatment group, time since initial diagnosis was > 12 months. It was confirmed by the respective study site that the patients had not received treatment between diagnosis and study entry. | For 6 patients in the LA-EP2006 treatment group and 10 patients in the Neulasta® treatment group, the date of initial diagnosis was incomplete. | Median | Full Range | months |
| |||||||||||||
| Disease stage | TNM Disease stage was defined according to the American Joint Committee on Cancer (AJCC): (I) = T1 N0 M0 / T0 N1mi M0 / T1 N1mi M0; (II) = T0 N1 M0 / T1 N1 M0 / T2 N0 M0 / T2 N1 M0 / T3 N0 M0; (III) = T0 N2 M0 / T1 N2 M0 / T2 N2 M0 / T3 N1 M0 / T3 N2 M0 / T4 N0 M0 / T4 N1 M0 / T4 N2 M0 / AnyT N3 M0; (IV) = AnyT AnyN M1; T: size or direct extent of the primary tumour; N: degree of spread to regional lymph nodes; N1mi: Micrometastases (> 0.2 mm and/or > 200 cells, but none > 2.0 mm); M: presence of distant; https://www.cancer.gov/types/breast/hp/breast-treatment-pdq#link/\_27 | Count of Participants | Participants |
| |||||||||||||||
| Previous breast cancer surgery | Count of Participants | Participants |
| ||||||||||||||||
| Previous radiotherapy | Count of Participants | Participants |
| ||||||||||||||||
| ECOG performance status | ECOG = Eastern Cooperative Oncology Group | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy | Mean duration of severe neutropenia, defined as number of consecutive days with ANC <0.5 × 10^9 cells/L (grade 4 neutropenia). | FAS set = full analysis set; PP set = per protocol set | Posted | Mean | Standard Deviation | days | 21 days (Cycle 1 of chemotherapy treatment) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Febrile Neutropenia (FN) | FN was defined as an oral temperature ≥ 38.3°C while having an absolute neutrophil count (ANC) < 0.5 × 10^9 cells/L. Serious treatment-emergent adverse events (TEAEs) were reconciled with the fever and ANC results recorded in the patient diary and CRF and therefore only the serious TEAEs of FN ("febrile neutropenia", "neutropenic sepsis") were taken into account. | Number of patients with at least one episode of febrile neutropenia by cycle and across all cycles (FAS set) | Posted | Count of Participants | Participants | across all cycles (18 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles | Fever was defined as an oral temperature ≥ 38.3°C. Fever episodes were characterized by maximum oral temperature and the number of patients who had fever at least once. | Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set | Posted | Count of Participants | Participants | across al cycles (18 weeks) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Depth of ANC Nadir in Cycle 1 | The depth of ANC nadir was defined as the patient's lowest ANC (10^9 cells/L) in Cycle 1. Only the evaluable patients with a depth of ANC in Cycle 1 are given. | FAS set = full analysis set | Posted | Mean | Standard Deviation | 10^9 cells/L | Cycle 1 (3 weeks) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With ANC Nadir Per Day in Cycle 1 | Numbers of patients with ANC nadir based per day during Cycle 1 are given. | FAS set = full analysis set | Posted | Count of Participants | Participants | Cycle 1 (3 weeks) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to ANC Recovery in Days in Cycle 1 | Time to absolute neutrophil count (ANC) recovery in Cycle 1 was defined as the time in days from ANC nadir until the patient's ANC had increased to ≥ 2 × 10^9 cells/L. Only the evaluable patients with a depth of ANC in Cycle 1 and a later increase of ANC ≥ 2 × 10^9 cells/L are given. | FAS set = full analysis set | Posted | Mean | Standard Deviation | days | across Cycle 1 (3 weeks) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Infections by Cycle and Across All Cycles | The number of patients with infections was recorded for each cycle and across all cycles. Infections were identified by the AE documentation page selecting all events coded with System Organ Class "Infections and Infestations". | Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set | Posted | Count of Participants | Participants | across all cycles (18 weeks) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mortality Due to Infection | Number of patients with death due to infections | FAS set = full analysis set | Posted | Count of Participants | Participants | Study course (41 weeks) |
|
|
Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LA-EP2006 | During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application. LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application. | 4 | 159 | 16 | 159 | 140 | 159 |
| EG001 | Neulasta® | During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application. Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application. | 2 | 157 | 21 | 157 | 128 | 157 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pancytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenic sepsis | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Diverticulitis | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Lower respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia bacterial | Infections and infestations | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Disease progression | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Cardio-respiratory arrest | Cardiac disorders | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Phlebitis | Vascular disorders | Systematic Assessment |
| ||
| Thrombophlebitis | Vascular disorders | Systematic Assessment |
| ||
| Venous thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Delirium febrile | Psychiatric disorders | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Vascular disorders | Vascular disorders | Systematic Assessment |
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| Cardiac disorders | Cardiac disorders | Systematic Assessment |
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| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Odema peripheral | General disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomitting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoe | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Respiratory tract infection viral | Infections and infestations | Systematic Assessment |
| ||
| Respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspatate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Weight decreased | Investigations | Systematic Assessment |
| ||
| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Strategic Planning, Biopharmaceutical Clinical Development | Sandoz | +49 (0) 8024 476 - 0 | biopharma.clinicaltrials@sandoz.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
Not provided
Not provided
Not provided
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| II |
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| III |
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| IV |
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| 1 (restricted in physically strenuous activity) |
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| PP |
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The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days. |
| The hierarchical test procedure aimed to show that
| ANCOVA | The primary endpoints was analyzed with analysis of covariance (ANCOVA). | 0.05 | Mean Difference (Net) | 0.07 | 2-Sided | 95 | -0.12 | 0.26 | LA-EP2006 is non-inferior to Neulasta® because the lower bound of the 95% CI is entirely above the non-inferiority margin of -0.6 days. | Non-Inferiority | The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days. |
| Units | Counts |
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| Participants |
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| Participants |
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