Breast Cancer, Non-Small Cell Lung Cancer, Ovarian Cancer, Small Cell Lung Cancer
Conditions
Brief summary
The primary objective was to describe the incidence of febrile neutropenia based on granulocyte-colony stimulating factor (G-CSF) use (primary, secondary, treatment, or no usage) in patients receiving myelotoxic chemotherapy.
Detailed description
This is a multi-center international observational study of patients receiving myelotoxic regimens, with an investigator assessed risk of febrile neutropenia ≥ 20%, for the treatment of solid tumors (breast, ovarian and lung). This is an observational study in which patient risk factors were qualitatively (but not quantitatively) assessed, and adherence to G-CSF primary prophylaxis was at the discretion of physicians and not mandated by the protocol.
Interventions
None listed
Sponsors
Amgen
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects greater than or equal to 18 years old with breast, ovarian or lung cancer receiving chemotherapy in any schedule, e.g. dose dense or standard chemotherapy. * These subjects must have an Investigator assessed risk of febrile neutropenia (FN) ≥20% (based on 2006 European Organisation for Research and Treatment of Cancer (EORTC) G-CSF Guidelines
Exclusion criteria
\- Subjects with concurrent administration of radiotherapy are not eligible (previous radiotherapy is permitted if terminated at least 2 weeks prior to commencing applicable chemotherapy in this study).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Febrile Neutropenia (FN) | Cycles 1 - 8 (approximately 24 weeks) | Febrile neutropenia was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². |
| Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia | Cycles 1 - 8 (approximately 24 weeks) | FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants in the No G-CSF use group received no G-CSF prophylaxis or treatment at any time during cycles 1 to 8. |
| Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia | Cycles 1 - 8 (approximately 24 weeks) | FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of Cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles. |
| Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia | Cycles 1 - 8 (approximately 24 weeks) | FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any daily G-CSF (e.g. filgrastim or lenograstim) starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles. |
| Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia | Cycles 1 - 8 (approximately 24 weeks) | FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of pegfilgrastim support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment. |
| Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia | Cycles 1 - 8 (approximately 24 weeks) | FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment. |
| Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia | Cycles 1 - 8 (approximately 24 weeks) | FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any other G-CSF starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles. |
| Percentage of Participants Receiving Secondary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia | Cycles 1 - 8 (approximately 24 weeks) | FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment. |
| Percentage of Participants Receiving Treatment With Pegfilgrastim Who Experienced Febrile Neutropenia | Cycles 1 - 8 (approximately 24 weeks) | FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with pegfilgrastim is defined as participants who started pegfilgrastim treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7. |
| Percentage of Participants Receiving Treatment With Any Daily G-CSF Who Experienced Febrile Neutropenia | Cycles 1 - 8 (approximately 24 weeks) | FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any daily G-CSF is defined as participants who started daily G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7. |
| Percentage of Participants Receiving Treatment With Any Other G-CSF Who Experienced Febrile Neutropenia | Cycles 1 - 8 (approximately 24 weeks) | FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any other G-CSF is defined as participants who started other G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Received G-CSF During Cycles 1 to 8 | Cycles 1 - 8 (approximately 24 weeks) | — |
| Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Pegfilgrastim | Cycles 1 - 8 (approximately 24 weeks) | The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles. |
| Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Any Daily G-CSF | Cycles 1 - 8 (approximately 24 weeks) | The average number of days of daily G-CSF use per cycle was calculated across all administered cycles. |
| Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Pegfilgrastim | Cycles 1 - 8 (approximately 24 weeks) | The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles. |
| Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Any Daily G-CSF | Cycles 1 - 8 (approximately 24 weeks) | The average number of days of daily G-CSF use per cycle was calculated across all administered cycles. |
| Number of Days of Treatment in Participants Receiving Treatment With Pegfilgrastim | Cycles 1 - 8 (approximately 24 weeks) | The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles. |
| Number of Days of Treatment in Participants Receiving Treatment With Any Daily G-CSF | Cycles 1 - 8 (approximately 24 weeks) | — |
| Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 | Cycles 2 - 8 (approximately 21 weeks) | A dose delay is defined as a delay of more than 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of participants with delays in chemotherapy administration are summarized by the length of delay (\> 3 days, \> 5 days, and \> 7 days) across cycles 2 through 8. |
| Percentage of Cycles With Chemotherapy Dose Delays | Cycles 2 - 8 (approximately 21 days) | A dose delay is defined as a delay of \> 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of cycles delayed are summarized by the length of delay (\> 3 days, \> 5 days, and \> 7 days) across cycles 2 through 8. |
| Percentage of Participants With Chemotherapy Dose Reductions | Cycles 1 - 8 (approximately 24 weeks) | A participant is considered to have a dose reduction in a given cycle if there was a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle. |
| Percentage of Cycles With Chemotherapy Dose Reductions | Cycles 1 - 8 (approximately 24 weeks) | A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle. |
| Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Cycles 2 - 8 (approximately 21 weeks) | A dose delay is defined as a delay of \> 3 days in the start of chemotherapy measured since the start of the previous cycle. |
| Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Cycles 1 - 8 (approximately 24 weeks) | A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle. |
| Number of Participants With Systemic Anti-infective Use in Cycles 1 to 8 | Cycles 1 - 8 (approximately 24 weeks) | Number of participants with systemic anti-infective use, including antibiotics, anti-fungal and virostatic for prophylaxis or treatment. |
| Number of Participants With Unplanned Hospitalizations | Cycles 1 - 8 (approximately 24 weeks) | Unplanned hospitalizations included only those which involved an overnight stay and occurred in cycles 1 to 8. |
| Investigator Assessed Clinical Response at End of Treatment | End of treatment (approximately 24 weeks) | — |
| Number of Participants With Hematological Toxicities | Cycles 1 - 8 (approximately 24 weeks) | The number of participants experiencing treatment related grade 3 and 4 hematological toxicities during cycles 1 to 8. Participants experiencing both Grade 3 and Grade 4 toxicities are reported under Grade 4 only (maximum toxicity). Toxicity grades for hematology data are defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0: Absolute neutrophil count (ANC) - Grade 3: \< 1.0 - 0.5 x 10\^9/L; ANC - Grade 4: \< 0.5 x 10\^9/L; White blood cells (WBC) - Grade 3: \< 2.0 - 1.0 x 10\^9/L; WBC - Grade 4: \< 1.0 x 10\^9/L; Hemoglobin - Grade 3: \< 8.0 - 6.5 g/dL; Hemoglobin - Grade 4: \< 6.5 g/dL; Platelets - Grade 3: \< 50 - 25 x 10\^9/L; Platelets - Grade 4: \< 25 x 10\^9/L. |
| Time to Disease Progression | From cycle 1, day 1 until end of the long-term follow-up; median time on follow-up from cycle 1, day 1 was 52 months. | Time to disease progression was calculated from cycle 1 day 1 to a date at which disease progression was first recorded. Participants who died due to causes other than disease progression were censored at the date of death. Participants who were alive and whose disease had not progressed at the most recent contact, or who were lost to follow-up, or with missing data, were censored at the date of last contact. Median time to disease progression was estimated from the Kaplan-Meier survival function. |
| Duration of Treatment With Erythropoiesis-stimulating Agents (ESAs) | Cycles 1 - 8 (approximately 24 weeks) | — |
| Reason for Treatment With Erythropoiesis-stimulating Agents | Cycles 1 - 8 (approximately 24 weeks) | The reason treatment with an ESA was initiated as recorded by the investigator; participants may have more than one reason for initiating treatment. |
| Hemoglobin Level at Initiation of Erythropoiesis-stimulating Agent Treatment | Cycles 1 - 8 (approximately 24 weeks) | — |
| Number of Clinical Visits in Cycles 1-8 by ESA Use | Cycles 1 - 8 (approximately 24 weeks) | The average number of clinical visits per month (28 day period) during cycles 1 to 8 and during the period of ESA treatment in cycles 1 to 8. |
| Percentage of Participants Who Received ESAs and Required a Red Blood Cell (RBC) Transfusion After 5 Weeks of ESA Treatment | From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks. | Kaplan-Meier estimate of the percentage of participants with RBC transfusions from five weeks post initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8. |
| Change in Hemoglobin During ESA Treatment Phase | Initiation of ESA treatment (last assessment on or prior to ESA day 1) and at end of ESA treatment; median duration of ESA treatment was 4 weeks, maximum was 23 weeks. | — |
| Percentage of Participants Who Received ESAs and Achieved Hematopoietic Response | Cycles 1 - 8 (approximately 24 weeks) | Kaplan-Meier estimate of the percentage of participants in cycles 1 to 8 receiving ESA treatment who achieved a hematopoietic response during the ESA treatment phase, defined as a hemoglobin concentration ≥ 12 g/dL or a ≥ 2 g/dL rise in hemoglobin after starting ESA treatment. |
| Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 9 g/dL After 5 Weeks ESA Treatment | From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks. | Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 9 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8. |
| Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 10 g/dL After 5 Weeks ESA Treatment | From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks. | Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 10 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8. |
| Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 11 g/dL After 5 Weeks ESA Treatment | From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks. | Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 11 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8. |
| Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 12 g/dL After 5 Weeks ESA Treatment | From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks. | Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 12 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8. |
| Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL After 5 Weeks ESA Treatment | From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks. | Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level from 10 to 12 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8. |
| Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 12 to 13 g/dL After 5 Weeks ESA Treatment | From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks. | Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level from 12 to 13 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8. |
| Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL 9 Weeks After Initiation of ESA Treatment | 9 weeks post initiation of ESA treatment | The percentage of participants achieving a hemoglobin level from 10 to 12 g/dL after 9 weeks of ESA treatment. |
| Number of Participants With Systemic Transfusions in Cycles 1 to 8 | Cycles 1 - 8 (approximately 24 weeks) | Number of participants who received transfusions, including platelets, packed red blood cells, whole blood, or other, during cycles 1 to 8. |
| Number of Transfusions Per Participant in Cycles 1 to 8 | Cycles 1 - 8 (approximately 24 weeks) | — |
Participant flow
Recruitment details
A total of 1370 patients were enrolled at 87 sites in Europe, 5 sites in Canada, and 10 sites in Australia from December 2007 to October 2009. Of these, 1347 participants were included in the full analysis set (FAS) consisting of all enrolled patients who met protocol defined eligibility criteria and started at least 1 cycle of chemotherapy.
Pre-assignment details
Eligible patients were enrolled sequentially. Upon completion of all planned chemotherapy cycles, or following cessation of chemotherapy for any reason, patients were followed-up annually for 5 years or until disease progression or death.
Participants by arm
| Arm | Count |
|---|---|
| Full Analysis Set Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy. | 1,347 |
| Total | 1,347 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative Reason | 24 |
| Overall Study | Death | 31 |
| Overall Study | Disease Progression | 94 |
| Overall Study | Hematological Adverse Event | 26 |
| Overall Study | Noncompliance | 3 |
| Overall Study | Non-hematological Adverse Event | 55 |
| Overall Study | Other | 38 |
| Overall Study | Protocol Deviation | 3 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Full Analysis Set |
|---|---|
| Age, Continuous | 56.4 years STANDARD_DEVIATION 11.3 |
| Anemia Symptoms Anorexia | 65 participants |
| Anemia Symptoms Depression | 113 participants |
| Anemia Symptoms Dizziness and/or vertigo | 49 participants |
| Anemia Symptoms Dyspnea | 101 participants |
| Anemia Symptoms Fatigue/tiredness | 197 participants |
| Anemia Symptoms Headache | 53 participants |
| Anemia Symptoms Impaired cognitive function | 17 participants |
| Anemia Symptoms Impaired immune system | 12 participants |
| Anemia Symptoms Irritability | 66 participants |
| Anemia Symptoms Metabolic dysfunction | 32 participants |
| Anemia Symptoms Nausea | 38 participants |
| Anemia Symptoms Pallor/Pale skin | 86 participants |
| Anemia Symptoms Sexual dysfunction | 54 participants |
| Anemia Symptoms Tachycardia and/or palpitations | 48 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - Normal Activity | 874 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 - Symptoms but Ambulatory | 346 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 2 - Confined to Bed ≤ 50% of Time | 99 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 3 - Confined to Bed ≥ 50% of Time | 9 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 4 - 100% Bedridden | 0 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Missing | 19 participants |
| Hemoglobin Level < 11 g/dL | 175 participants |
| Hemoglobin Level ≥ 11 g/dL | 1091 participants |
| Hemoglobin Level Missing | 81 participants |
| Prior Febrile Neutropenia Episodes Any prior FN episodes | 35 participants |
| Prior Febrile Neutropenia Episodes Missing | 450 participants |
| Prior Febrile Neutropenia Episodes No prior FN episodes | 213 participants |
| Prior Treatment Chemotherapy and radiotherapy | 62 participants |
| Prior Treatment Chemotherapy only | 88 participants |
| Prior Treatment Missing | 2 participants |
| Prior Treatment None | 647 participants |
| Prior Treatment Other | 80 participants |
| Prior Treatment Radiotherapy only | 19 participants |
| Prior Treatment Surgery | 449 participants |
| Race/Ethnicity, Customized Asian | 4 participants |
| Race/Ethnicity, Customized Black or African American | 4 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 participants |
| Race/Ethnicity, Customized Not Applicable | 8 participants |
| Race/Ethnicity, Customized Other | 4 participants |
| Race/Ethnicity, Customized White or Caucasian | 1324 participants |
| Sex: Female, Male Female | 1072 Participants |
| Sex: Female, Male Male | 275 Participants |
| Tumor Type Breast cancer | 829 participants |
| Tumor Type Non-small cell lung cancer (NSCLC) | 224 participants |
| Tumor Type Ovarian cancer | 157 participants |
| Tumor Type Small cell lung cancer (SCLC) | 137 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 157 | 0 / 224 | 1 / 137 | 37 / 738 | 1 / 90 | 38 / 829 |
| serious Total, serious adverse events | 0 / 157 | 1 / 224 | 0 / 137 | 1 / 738 | 0 / 90 | 1 / 829 |
Outcome results
Primary
Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any other G-CSF starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set participants who received primary prophylaxis with other G-CSF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ovarian | Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia | 0 percentage of participants |
| NSCLC | Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia | 0 percentage of participants |
| Breast Stage I-III | Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia | 17 percentage of participants |
| Breast Metastatic | Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia | 0 percentage of participants |
| Breast Total | Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia | 14 percentage of participants |
Primary
Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any daily G-CSF (e.g. filgrastim or lenograstim) starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set participants who received primary prophylaxis with any daily G-CSF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ovarian | Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia | 0 percentage of participants |
| NSCLC | Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia | 20 percentage of participants |
| SCLC | Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia | 9 percentage of participants |
| Breast Stage I-III | Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia | 6 percentage of participants |
| Breast Metastatic | Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia | 17 percentage of participants |
| Breast Total | Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia | 7 percentage of participants |
Primary
Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of Cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set participants who received primary prophylaxis with pegfilgrastim
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ovarian | Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia | 0 percentage of participants |
| NSCLC | Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia | 0 percentage of participants |
| SCLC | Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia | 21 percentage of participants |
| Breast Stage I-III | Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia | 9 percentage of participants |
| Breast Metastatic | Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia | 9 percentage of participants |
| Breast Total | Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia | 9 percentage of participants |
Primary
Percentage of Participants Receiving Secondary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set participants who received secondary prophylaxis with other G-CSF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ovarian | Percentage of Participants Receiving Secondary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia | 25 percentage of participants |
| NSCLC | Percentage of Participants Receiving Secondary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia | 0 percentage of participants |
| Breast Stage I-III | Percentage of Participants Receiving Secondary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia | 0 percentage of participants |
| Breast Metastatic | Percentage of Participants Receiving Secondary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia | 0 percentage of participants |
| Breast Total | Percentage of Participants Receiving Secondary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia | 0 percentage of participants |
Primary
Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set participants who received secondary prophylaxis with any daily G-CSF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ovarian | Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia | 27 percentage of participants |
| NSCLC | Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia | 13 percentage of participants |
| SCLC | Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia | 15 percentage of participants |
| Breast Stage I-III | Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia | 20 percentage of participants |
| Breast Metastatic | Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia | 22 percentage of participants |
| Breast Total | Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia | 21 percentage of participants |
Primary
Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of pegfilgrastim support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set participants who received secondary prophylaxis with pegfilgrastim
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ovarian | Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia | 0 percentage of participants |
| NSCLC | Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia | 36 percentage of participants |
| SCLC | Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia | 40 percentage of participants |
| Breast Stage I-III | Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia | 14 percentage of participants |
| Breast Metastatic | Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia | 33 percentage of participants |
| Breast Total | Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia | 16 percentage of participants |
Primary
Percentage of Participants Receiving Treatment With Any Daily G-CSF Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any daily G-CSF is defined as participants who started daily G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set participants who received treatment with any daily G-CSF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ovarian | Percentage of Participants Receiving Treatment With Any Daily G-CSF Who Experienced Febrile Neutropenia | 44 percentage of participants |
| NSCLC | Percentage of Participants Receiving Treatment With Any Daily G-CSF Who Experienced Febrile Neutropenia | 13 percentage of participants |
| SCLC | Percentage of Participants Receiving Treatment With Any Daily G-CSF Who Experienced Febrile Neutropenia | 13 percentage of participants |
| Breast Stage I-III | Percentage of Participants Receiving Treatment With Any Daily G-CSF Who Experienced Febrile Neutropenia | 12 percentage of participants |
| Breast Metastatic | Percentage of Participants Receiving Treatment With Any Daily G-CSF Who Experienced Febrile Neutropenia | 25 percentage of participants |
| Breast Total | Percentage of Participants Receiving Treatment With Any Daily G-CSF Who Experienced Febrile Neutropenia | 14 percentage of participants |
Primary
Percentage of Participants Receiving Treatment With Any Other G-CSF Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any other G-CSF is defined as participants who started other G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set participants who received treatment with any other G-CSF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NSCLC | Percentage of Participants Receiving Treatment With Any Other G-CSF Who Experienced Febrile Neutropenia | 100 percentage of participants |
Primary
Percentage of Participants Receiving Treatment With Pegfilgrastim Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with pegfilgrastim is defined as participants who started pegfilgrastim treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set participants who received treatment with pegfilgrastim
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ovarian | Percentage of Participants Receiving Treatment With Pegfilgrastim Who Experienced Febrile Neutropenia | 0 percentage of participants |
| NSCLC | Percentage of Participants Receiving Treatment With Pegfilgrastim Who Experienced Febrile Neutropenia | 0 percentage of participants |
| SCLC | Percentage of Participants Receiving Treatment With Pegfilgrastim Who Experienced Febrile Neutropenia | 0 percentage of participants |
Primary
Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants in the No G-CSF use group received no G-CSF prophylaxis or treatment at any time during cycles 1 to 8.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set participants who received no prophylaxis or treatment with any G-CSF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ovarian | Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia | 4 percentage of participants |
| NSCLC | Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia | 3 percentage of participants |
| SCLC | Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia | 5 percentage of participants |
| Breast Stage I-III | Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia | 1 percentage of participants |
| Breast Metastatic | Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia | 0 percentage of participants |
| Breast Total | Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia | 1 percentage of participants |
Primary
Percentage of Participants With Febrile Neutropenia (FN)
Febrile neutropenia was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm².
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set; Note: One participant with breast cancer had disease stage missing.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ovarian | Percentage of Participants With Febrile Neutropenia (FN) | 8 percentage of participants |
| NSCLC | Percentage of Participants With Febrile Neutropenia (FN) | 8 percentage of participants |
| SCLC | Percentage of Participants With Febrile Neutropenia (FN) | 15 percentage of participants |
| Breast Stage I-III | Percentage of Participants With Febrile Neutropenia (FN) | 9 percentage of participants |
| Breast Metastatic | Percentage of Participants With Febrile Neutropenia (FN) | 11 percentage of participants |
| Breast Total | Percentage of Participants With Febrile Neutropenia (FN) | 9 percentage of participants |
Secondary
Change in Hemoglobin During ESA Treatment Phase
Time frame: Initiation of ESA treatment (last assessment on or prior to ESA day 1) and at end of ESA treatment; median duration of ESA treatment was 4 weeks, maximum was 23 weeks.
Population: Participants who received treatment with an ESA and with hemoglobin measurements available at both time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ovarian | Change in Hemoglobin During ESA Treatment Phase | 0.38 g/dL | Standard Deviation 1.3 |
Secondary
Duration of Treatment With Erythropoiesis-stimulating Agents (ESAs)
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Participants who received treatment with an ESA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ovarian | Duration of Treatment With Erythropoiesis-stimulating Agents (ESAs) | 5.3 weeks | Standard Deviation 4.6 |
Secondary
Hemoglobin Level at Initiation of Erythropoiesis-stimulating Agent Treatment
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Participants who received treatment with an ESA
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Ovarian | Hemoglobin Level at Initiation of Erythropoiesis-stimulating Agent Treatment | Hemoglobin < 9 g/dL | 19 participants | 4.6 |
| Ovarian | Hemoglobin Level at Initiation of Erythropoiesis-stimulating Agent Treatment | Hemoglobin 9 - 11 g/dL | 95 participants | — |
| Ovarian | Hemoglobin Level at Initiation of Erythropoiesis-stimulating Agent Treatment | Hemoglobin > 11 g/dL | 29 participants | — |
| Ovarian | Hemoglobin Level at Initiation of Erythropoiesis-stimulating Agent Treatment | Missing | 4 participants | — |
Secondary
Investigator Assessed Clinical Response at End of Treatment
Time frame: End of treatment (approximately 24 weeks)
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ovarian | Investigator Assessed Clinical Response at End of Treatment | Complete response | 49 participants |
| Ovarian | Investigator Assessed Clinical Response at End of Treatment | Partial response | 29 participants |
| Ovarian | Investigator Assessed Clinical Response at End of Treatment | Stable disease/No response | 23 participants |
| Ovarian | Investigator Assessed Clinical Response at End of Treatment | Progressive disease | 31 participants |
| Ovarian | Investigator Assessed Clinical Response at End of Treatment | Not done | 25 participants |
| Ovarian | Investigator Assessed Clinical Response at End of Treatment | Missing | 0 participants |
| NSCLC | Investigator Assessed Clinical Response at End of Treatment | Missing | 0 participants |
| NSCLC | Investigator Assessed Clinical Response at End of Treatment | Stable disease/No response | 41 participants |
| NSCLC | Investigator Assessed Clinical Response at End of Treatment | Partial response | 60 participants |
| NSCLC | Investigator Assessed Clinical Response at End of Treatment | Progressive disease | 64 participants |
| NSCLC | Investigator Assessed Clinical Response at End of Treatment | Not done | 51 participants |
| NSCLC | Investigator Assessed Clinical Response at End of Treatment | Complete response | 8 participants |
| SCLC | Investigator Assessed Clinical Response at End of Treatment | Missing | 0 participants |
| SCLC | Investigator Assessed Clinical Response at End of Treatment | Progressive disease | 33 participants |
| SCLC | Investigator Assessed Clinical Response at End of Treatment | Partial response | 38 participants |
| SCLC | Investigator Assessed Clinical Response at End of Treatment | Stable disease/No response | 29 participants |
| SCLC | Investigator Assessed Clinical Response at End of Treatment | Not done | 20 participants |
| SCLC | Investigator Assessed Clinical Response at End of Treatment | Complete response | 17 participants |
| Breast Stage I-III | Investigator Assessed Clinical Response at End of Treatment | Missing | 17 participants |
| Breast Stage I-III | Investigator Assessed Clinical Response at End of Treatment | Not done | 383 participants |
| Breast Stage I-III | Investigator Assessed Clinical Response at End of Treatment | Partial response | 77 participants |
| Breast Stage I-III | Investigator Assessed Clinical Response at End of Treatment | Stable disease/No response | 35 participants |
| Breast Stage I-III | Investigator Assessed Clinical Response at End of Treatment | Progressive disease | 8 participants |
| Breast Stage I-III | Investigator Assessed Clinical Response at End of Treatment | Complete response | 218 participants |
| Breast Metastatic | Investigator Assessed Clinical Response at End of Treatment | Not done | 21 participants |
| Breast Metastatic | Investigator Assessed Clinical Response at End of Treatment | Missing | 0 participants |
| Breast Metastatic | Investigator Assessed Clinical Response at End of Treatment | Partial response | 36 participants |
| Breast Metastatic | Investigator Assessed Clinical Response at End of Treatment | Stable disease/No response | 11 participants |
| Breast Metastatic | Investigator Assessed Clinical Response at End of Treatment | Progressive disease | 18 participants |
| Breast Metastatic | Investigator Assessed Clinical Response at End of Treatment | Complete response | 4 participants |
| Breast Total | Investigator Assessed Clinical Response at End of Treatment | Stable disease/No response | 46 participants |
| Breast Total | Investigator Assessed Clinical Response at End of Treatment | Complete response | 222 participants |
| Breast Total | Investigator Assessed Clinical Response at End of Treatment | Partial response | 114 participants |
| Breast Total | Investigator Assessed Clinical Response at End of Treatment | Missing | 17 participants |
| Breast Total | Investigator Assessed Clinical Response at End of Treatment | Progressive disease | 26 participants |
| Breast Total | Investigator Assessed Clinical Response at End of Treatment | Not done | 404 participants |
Secondary
Number of Clinical Visits in Cycles 1-8 by ESA Use
The average number of clinical visits per month (28 day period) during cycles 1 to 8 and during the period of ESA treatment in cycles 1 to 8.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ovarian | Number of Clinical Visits in Cycles 1-8 by ESA Use | Visits per month during cycles 1 - 8 | 3.1 visits per month | Standard Deviation 1.6 |
| Ovarian | Number of Clinical Visits in Cycles 1-8 by ESA Use | Visits per month during period of ESA treatment | 3.9 visits per month | Standard Deviation 3.2 |
| NSCLC | Number of Clinical Visits in Cycles 1-8 by ESA Use | Visits per month during cycles 1 - 8 | 2.8 visits per month | Standard Deviation 1.7 |
| NSCLC | Number of Clinical Visits in Cycles 1-8 by ESA Use | Visits per month during period of ESA treatment | NA visits per month | — |
Secondary
Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Any Daily G-CSF
The average number of days of daily G-CSF use per cycle was calculated across all administered cycles.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set participants who received primary prophylaxis with any daily G-CSF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ovarian | Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Any Daily G-CSF | 3.67 days | Standard Deviation 1.63 |
| NSCLC | Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Any Daily G-CSF | 3.95 days | Standard Deviation 1.18 |
| SCLC | Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Any Daily G-CSF | 4.95 days | Standard Deviation 1.31 |
| Breast Stage I-III | Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Any Daily G-CSF | 4.77 days | Standard Deviation 1.72 |
| Breast Metastatic | Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Any Daily G-CSF | 5.85 days | Standard Deviation 2.64 |
| Breast Total | Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Any Daily G-CSF | 4.88 days | Standard Deviation 1.84 |
Secondary
Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Pegfilgrastim
The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set participants who received primary prophylaxis with pegfilgrastim
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ovarian | Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Pegfilgrastim | 1.00 days | Standard Deviation 0 |
| NSCLC | Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Pegfilgrastim | 1.00 days | Standard Deviation 0 |
| SCLC | Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Pegfilgrastim | 1.01 days | Standard Deviation 0.03 |
| Breast Stage I-III | Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Pegfilgrastim | 1.00 days | Standard Deviation 0.05 |
| Breast Metastatic | Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Pegfilgrastim | 1.01 days | Standard Deviation 0.03 |
| Breast Total | Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Pegfilgrastim | 1.00 days | Standard Deviation 0.04 |
Secondary
Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Any Daily G-CSF
The average number of days of daily G-CSF use per cycle was calculated across all administered cycles.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set participants who received secondary prophylaxis with any daily G-CSF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ovarian | Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Any Daily G-CSF | 3.66 days | Standard Deviation 1.82 |
| NSCLC | Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Any Daily G-CSF | 4.28 days | Standard Deviation 0.87 |
| SCLC | Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Any Daily G-CSF | 4.04 days | Standard Deviation 1.61 |
| Breast Stage I-III | Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Any Daily G-CSF | 4.74 days | Standard Deviation 2.64 |
| Breast Metastatic | Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Any Daily G-CSF | 3.50 days | Standard Deviation 0.95 |
| Breast Total | Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Any Daily G-CSF | 4.58 days | Standard Deviation 2.53 |
Secondary
Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Pegfilgrastim
The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set participants who received secondary prophylaxis with pegfilgrastim
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ovarian | Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Pegfilgrastim | 1.00 days | Standard Deviation 0 |
| NSCLC | Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Pegfilgrastim | 1.00 days | Standard Deviation 0 |
| SCLC | Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Pegfilgrastim | 1.04 days | Standard Deviation 0.12 |
| Breast Stage I-III | Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Pegfilgrastim | 1.02 days | Standard Deviation 0.21 |
| Breast Metastatic | Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Pegfilgrastim | 1.00 days | Standard Deviation 0 |
| Breast Total | Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Pegfilgrastim | 1.02 days | Standard Deviation 0.2 |
Secondary
Number of Days of Treatment in Participants Receiving Treatment With Any Daily G-CSF
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set participants who received treatment with any daily G-CSF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ovarian | Number of Days of Treatment in Participants Receiving Treatment With Any Daily G-CSF | 3.11 days | Standard Deviation 1.92 |
| NSCLC | Number of Days of Treatment in Participants Receiving Treatment With Any Daily G-CSF | 4.45 days | Standard Deviation 1.18 |
| SCLC | Number of Days of Treatment in Participants Receiving Treatment With Any Daily G-CSF | 2.83 days | Standard Deviation 1.21 |
| Breast Stage I-III | Number of Days of Treatment in Participants Receiving Treatment With Any Daily G-CSF | 2.95 days | Standard Deviation 1.5 |
| Breast Metastatic | Number of Days of Treatment in Participants Receiving Treatment With Any Daily G-CSF | 2.38 days | Standard Deviation 0.75 |
| Breast Total | Number of Days of Treatment in Participants Receiving Treatment With Any Daily G-CSF | 2.84 days | Standard Deviation 1.39 |
Secondary
Number of Days of Treatment in Participants Receiving Treatment With Pegfilgrastim
The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set participants who received treatment with pegfilgrastim
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ovarian | Number of Days of Treatment in Participants Receiving Treatment With Pegfilgrastim | 1.40 days | Standard Deviation 0.89 |
| NSCLC | Number of Days of Treatment in Participants Receiving Treatment With Pegfilgrastim | 1.00 days | Standard Deviation 0 |
| SCLC | Number of Days of Treatment in Participants Receiving Treatment With Pegfilgrastim | 1.00 days | — |
Secondary
Number of Participants Who Received G-CSF During Cycles 1 to 8
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ovarian | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Primary Prophylaxis - Any Daily G-CSF | 6 participants |
| Ovarian | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Secondary Prophylaxis - Pegfilgrastim | 11 participants |
| Ovarian | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Secondary Prophylaxis - Any Daily G-CSF | 15 participants |
| Ovarian | Number of Participants Who Received G-CSF During Cycles 1 to 8 | No G-CSF Used | 82 participants |
| Ovarian | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Primary Prophylaxis - Pegfilgrastim | 24 participants |
| Ovarian | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Treatment - Other G-CSF | 0 participants |
| Ovarian | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Treatment - Any Daily G-CSF | 9 participants |
| Ovarian | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Treatment - Pegfilgrastim | 5 participants |
| Ovarian | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Primary Prophylaxis - Other G-CSF | 1 participants |
| Ovarian | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Secondary Prophylaxis - Other G-CSF | 4 participants |
| NSCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | No G-CSF Used | 120 participants |
| NSCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Secondary Prophylaxis - Any Daily G-CSF | 24 participants |
| NSCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Treatment - Any Daily G-CSF | 15 participants |
| NSCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Secondary Prophylaxis - Pegfilgrastim | 14 participants |
| NSCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Primary Prophylaxis - Any Daily G-CSF | 20 participants |
| NSCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Treatment - Other G-CSF | 1 participants |
| NSCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Treatment - Pegfilgrastim | 2 participants |
| NSCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Primary Prophylaxis - Other G-CSF | 3 participants |
| NSCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Primary Prophylaxis - Pegfilgrastim | 22 participants |
| NSCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Secondary Prophylaxis - Other G-CSF | 3 participants |
| SCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Secondary Prophylaxis - Any Daily G-CSF | 13 participants |
| SCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Primary Prophylaxis - Any Daily G-CSF | 11 participants |
| SCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Treatment - Other G-CSF | 0 participants |
| SCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Primary Prophylaxis - Pegfilgrastim | 33 participants |
| SCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Primary Prophylaxis - Other G-CSF | 0 participants |
| SCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Secondary Prophylaxis - Pegfilgrastim | 15 participants |
| SCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Secondary Prophylaxis - Other G-CSF | 0 participants |
| SCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Treatment - Pegfilgrastim | 1 participants |
| SCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Treatment - Any Daily G-CSF | 8 participants |
| SCLC | Number of Participants Who Received G-CSF During Cycles 1 to 8 | No G-CSF Used | 56 participants |
| Breast Stage I-III | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Primary Prophylaxis - Pegfilgrastim | 360 participants |
| Breast Stage I-III | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Primary Prophylaxis - Any Daily G-CSF | 51 participants |
| Breast Stage I-III | Number of Participants Who Received G-CSF During Cycles 1 to 8 | No G-CSF Used | 147 participants |
| Breast Stage I-III | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Treatment - Pegfilgrastim | 0 participants |
| Breast Stage I-III | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Secondary Prophylaxis - Other G-CSF | 1 participants |
| Breast Stage I-III | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Primary Prophylaxis - Other G-CSF | 6 participants |
| Breast Stage I-III | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Secondary Prophylaxis - Any Daily G-CSF | 64 participants |
| Breast Stage I-III | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Secondary Prophylaxis - Pegfilgrastim | 92 participants |
| Breast Stage I-III | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Treatment - Other G-CSF | 0 participants |
| Breast Stage I-III | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Treatment - Any Daily G-CSF | 17 participants |
| Breast Metastatic | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Primary Prophylaxis - Any Daily G-CSF | 6 participants |
| Breast Metastatic | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Treatment - Other G-CSF | 0 participants |
| Breast Metastatic | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Secondary Prophylaxis - Other G-CSF | 1 participants |
| Breast Metastatic | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Secondary Prophylaxis - Pegfilgrastim | 9 participants |
| Breast Metastatic | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Primary Prophylaxis - Other G-CSF | 1 participants |
| Breast Metastatic | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Treatment - Any Daily G-CSF | 4 participants |
| Breast Metastatic | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Treatment - Pegfilgrastim | 0 participants |
| Breast Metastatic | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Secondary Prophylaxis - Any Daily G-CSF | 9 participants |
| Breast Metastatic | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Primary Prophylaxis - Pegfilgrastim | 32 participants |
| Breast Metastatic | Number of Participants Who Received G-CSF During Cycles 1 to 8 | No G-CSF Used | 28 participants |
| Breast Total | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Primary Prophylaxis - Other G-CSF | 7 participants |
| Breast Total | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Secondary Prophylaxis - Any Daily G-CSF | 73 participants |
| Breast Total | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Primary Prophylaxis - Any Daily G-CSF | 57 participants |
| Breast Total | Number of Participants Who Received G-CSF During Cycles 1 to 8 | No G-CSF Used | 175 participants |
| Breast Total | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Secondary Prophylaxis - Other G-CSF | 2 participants |
| Breast Total | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Treatment - Pegfilgrastim | 0 participants |
| Breast Total | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Primary Prophylaxis - Pegfilgrastim | 393 participants |
| Breast Total | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Treatment - Any Daily G-CSF | 21 participants |
| Breast Total | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Treatment - Other G-CSF | 0 participants |
| Breast Total | Number of Participants Who Received G-CSF During Cycles 1 to 8 | Secondary Prophylaxis - Pegfilgrastim | 101 participants |
Secondary
Number of Participants With Hematological Toxicities
The number of participants experiencing treatment related grade 3 and 4 hematological toxicities during cycles 1 to 8. Participants experiencing both Grade 3 and Grade 4 toxicities are reported under Grade 4 only (maximum toxicity). Toxicity grades for hematology data are defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0: Absolute neutrophil count (ANC) - Grade 3: \< 1.0 - 0.5 x 10\^9/L; ANC - Grade 4: \< 0.5 x 10\^9/L; White blood cells (WBC) - Grade 3: \< 2.0 - 1.0 x 10\^9/L; WBC - Grade 4: \< 1.0 x 10\^9/L; Hemoglobin - Grade 3: \< 8.0 - 6.5 g/dL; Hemoglobin - Grade 4: \< 6.5 g/dL; Platelets - Grade 3: \< 50 - 25 x 10\^9/L; Platelets - Grade 4: \< 25 x 10\^9/L.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ovarian | Number of Participants With Hematological Toxicities | Grade 4 white blood cells | 6 participants |
| Ovarian | Number of Participants With Hematological Toxicities | Grade 3 white blood cells | 17 participants |
| Ovarian | Number of Participants With Hematological Toxicities | Grade 4 platelets | 3 participants |
| Ovarian | Number of Participants With Hematological Toxicities | Grade 3 platelets | 8 participants |
| Ovarian | Number of Participants With Hematological Toxicities | Grade 3 absolute neutrophil count | 19 participants |
| Ovarian | Number of Participants With Hematological Toxicities | Grade 3 hemoglobin | 6 participants |
| Ovarian | Number of Participants With Hematological Toxicities | Grade 4 hemoglobin | 1 participants |
| Ovarian | Number of Participants With Hematological Toxicities | Grade 4 absolute neutrophil count | 23 participants |
| NSCLC | Number of Participants With Hematological Toxicities | Grade 3 absolute neutrophil count | 7 participants |
| NSCLC | Number of Participants With Hematological Toxicities | Grade 3 hemoglobin | 12 participants |
| NSCLC | Number of Participants With Hematological Toxicities | Grade 4 hemoglobin | 6 participants |
| NSCLC | Number of Participants With Hematological Toxicities | Grade 4 absolute neutrophil count | 18 participants |
| NSCLC | Number of Participants With Hematological Toxicities | Grade 3 platelets | 2 participants |
| NSCLC | Number of Participants With Hematological Toxicities | Grade 3 white blood cells | 11 participants |
| NSCLC | Number of Participants With Hematological Toxicities | Grade 4 platelets | 3 participants |
| NSCLC | Number of Participants With Hematological Toxicities | Grade 4 white blood cells | 8 participants |
| SCLC | Number of Participants With Hematological Toxicities | Grade 4 platelets | 4 participants |
| SCLC | Number of Participants With Hematological Toxicities | Grade 3 platelets | 3 participants |
| SCLC | Number of Participants With Hematological Toxicities | Grade 3 absolute neutrophil count | 9 participants |
| SCLC | Number of Participants With Hematological Toxicities | Grade 3 hemoglobin | 15 participants |
| SCLC | Number of Participants With Hematological Toxicities | Grade 4 hemoglobin | 5 participants |
| SCLC | Number of Participants With Hematological Toxicities | Grade 4 absolute neutrophil count | 13 participants |
| SCLC | Number of Participants With Hematological Toxicities | Grade 4 white blood cells | 11 participants |
| SCLC | Number of Participants With Hematological Toxicities | Grade 3 white blood cells | 5 participants |
| Breast Stage I-III | Number of Participants With Hematological Toxicities | Grade 3 platelets | 6 participants |
| Breast Stage I-III | Number of Participants With Hematological Toxicities | Grade 4 platelets | 3 participants |
| Breast Stage I-III | Number of Participants With Hematological Toxicities | Grade 4 absolute neutrophil count | 89 participants |
| Breast Stage I-III | Number of Participants With Hematological Toxicities | Grade 3 white blood cells | 71 participants |
| Breast Stage I-III | Number of Participants With Hematological Toxicities | Grade 4 white blood cells | 38 participants |
| Breast Stage I-III | Number of Participants With Hematological Toxicities | Grade 3 absolute neutrophil count | 45 participants |
| Breast Stage I-III | Number of Participants With Hematological Toxicities | Grade 3 hemoglobin | 47 participants |
| Breast Stage I-III | Number of Participants With Hematological Toxicities | Grade 4 hemoglobin | 9 participants |
| Breast Metastatic | Number of Participants With Hematological Toxicities | Grade 4 white blood cells | 12 participants |
| Breast Metastatic | Number of Participants With Hematological Toxicities | Grade 3 platelets | 3 participants |
| Breast Metastatic | Number of Participants With Hematological Toxicities | Grade 4 hemoglobin | 3 participants |
| Breast Metastatic | Number of Participants With Hematological Toxicities | Grade 3 absolute neutrophil count | 5 participants |
| Breast Metastatic | Number of Participants With Hematological Toxicities | Grade 3 white blood cells | 8 participants |
| Breast Metastatic | Number of Participants With Hematological Toxicities | Grade 4 absolute neutrophil count | 18 participants |
| Breast Metastatic | Number of Participants With Hematological Toxicities | Grade 4 platelets | 0 participants |
| Breast Metastatic | Number of Participants With Hematological Toxicities | Grade 3 hemoglobin | 7 participants |
| Breast Total | Number of Participants With Hematological Toxicities | Grade 4 platelets | 3 participants |
| Breast Total | Number of Participants With Hematological Toxicities | Grade 3 absolute neutrophil count | 50 participants |
| Breast Total | Number of Participants With Hematological Toxicities | Grade 4 absolute neutrophil count | 107 participants |
| Breast Total | Number of Participants With Hematological Toxicities | Grade 3 white blood cells | 79 participants |
| Breast Total | Number of Participants With Hematological Toxicities | Grade 4 white blood cells | 50 participants |
| Breast Total | Number of Participants With Hematological Toxicities | Grade 4 hemoglobin | 12 participants |
| Breast Total | Number of Participants With Hematological Toxicities | Grade 3 platelets | 9 participants |
| Breast Total | Number of Participants With Hematological Toxicities | Grade 3 hemoglobin | 54 participants |
Secondary
Number of Participants With Systemic Anti-infective Use in Cycles 1 to 8
Number of participants with systemic anti-infective use, including antibiotics, anti-fungal and virostatic for prophylaxis or treatment.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ovarian | Number of Participants With Systemic Anti-infective Use in Cycles 1 to 8 | 23 participants |
| NSCLC | Number of Participants With Systemic Anti-infective Use in Cycles 1 to 8 | 46 participants |
| SCLC | Number of Participants With Systemic Anti-infective Use in Cycles 1 to 8 | 53 participants |
| Breast Stage I-III | Number of Participants With Systemic Anti-infective Use in Cycles 1 to 8 | 198 participants |
| Breast Metastatic | Number of Participants With Systemic Anti-infective Use in Cycles 1 to 8 | 20 participants |
| Breast Total | Number of Participants With Systemic Anti-infective Use in Cycles 1 to 8 | 218 participants |
Secondary
Number of Participants With Systemic Transfusions in Cycles 1 to 8
Number of participants who received transfusions, including platelets, packed red blood cells, whole blood, or other, during cycles 1 to 8.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ovarian | Number of Participants With Systemic Transfusions in Cycles 1 to 8 | 20 participants |
| NSCLC | Number of Participants With Systemic Transfusions in Cycles 1 to 8 | 23 participants |
| SCLC | Number of Participants With Systemic Transfusions in Cycles 1 to 8 | 26 participants |
| Breast Stage I-III | Number of Participants With Systemic Transfusions in Cycles 1 to 8 | 25 participants |
| Breast Metastatic | Number of Participants With Systemic Transfusions in Cycles 1 to 8 | 4 participants |
| Breast Total | Number of Participants With Systemic Transfusions in Cycles 1 to 8 | 29 participants |
Secondary
Number of Participants With Unplanned Hospitalizations
Unplanned hospitalizations included only those which involved an overnight stay and occurred in cycles 1 to 8.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ovarian | Number of Participants With Unplanned Hospitalizations | 26 participants |
| NSCLC | Number of Participants With Unplanned Hospitalizations | 52 participants |
| SCLC | Number of Participants With Unplanned Hospitalizations | 41 participants |
| Breast Stage I-III | Number of Participants With Unplanned Hospitalizations | 107 participants |
| Breast Metastatic | Number of Participants With Unplanned Hospitalizations | 18 participants |
| Breast Total | Number of Participants With Unplanned Hospitalizations | 125 participants |
Secondary
Number of Transfusions Per Participant in Cycles 1 to 8
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ovarian | Number of Transfusions Per Participant in Cycles 1 to 8 | > 2 Transfusions | 8 participants |
| Ovarian | Number of Transfusions Per Participant in Cycles 1 to 8 | No Transfusions | 137 participants |
| Ovarian | Number of Transfusions Per Participant in Cycles 1 to 8 | 2 Transfusions | 4 participants |
| Ovarian | Number of Transfusions Per Participant in Cycles 1 to 8 | 1 Transfusion | 8 participants |
| NSCLC | Number of Transfusions Per Participant in Cycles 1 to 8 | 2 Transfusions | 4 participants |
| NSCLC | Number of Transfusions Per Participant in Cycles 1 to 8 | > 2 Transfusions | 3 participants |
| NSCLC | Number of Transfusions Per Participant in Cycles 1 to 8 | No Transfusions | 201 participants |
| NSCLC | Number of Transfusions Per Participant in Cycles 1 to 8 | 1 Transfusion | 16 participants |
| SCLC | Number of Transfusions Per Participant in Cycles 1 to 8 | 2 Transfusions | 5 participants |
| SCLC | Number of Transfusions Per Participant in Cycles 1 to 8 | No Transfusions | 111 participants |
| SCLC | Number of Transfusions Per Participant in Cycles 1 to 8 | 1 Transfusion | 17 participants |
| SCLC | Number of Transfusions Per Participant in Cycles 1 to 8 | > 2 Transfusions | 4 participants |
| Breast Stage I-III | Number of Transfusions Per Participant in Cycles 1 to 8 | 2 Transfusions | 3 participants |
| Breast Stage I-III | Number of Transfusions Per Participant in Cycles 1 to 8 | > 2 Transfusions | 3 participants |
| Breast Stage I-III | Number of Transfusions Per Participant in Cycles 1 to 8 | No Transfusions | 713 participants |
| Breast Stage I-III | Number of Transfusions Per Participant in Cycles 1 to 8 | 1 Transfusion | 19 participants |
| Breast Metastatic | Number of Transfusions Per Participant in Cycles 1 to 8 | > 2 Transfusions | 1 participants |
| Breast Metastatic | Number of Transfusions Per Participant in Cycles 1 to 8 | No Transfusions | 86 participants |
| Breast Metastatic | Number of Transfusions Per Participant in Cycles 1 to 8 | 1 Transfusion | 2 participants |
| Breast Metastatic | Number of Transfusions Per Participant in Cycles 1 to 8 | 2 Transfusions | 1 participants |
| Breast Total | Number of Transfusions Per Participant in Cycles 1 to 8 | 2 Transfusions | 4 participants |
| Breast Total | Number of Transfusions Per Participant in Cycles 1 to 8 | 1 Transfusion | 21 participants |
| Breast Total | Number of Transfusions Per Participant in Cycles 1 to 8 | No Transfusions | 800 participants |
| Breast Total | Number of Transfusions Per Participant in Cycles 1 to 8 | > 2 Transfusions | 4 participants |
Secondary
Percentage of Cycles With Chemotherapy Dose Delays
A dose delay is defined as a delay of \> 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of cycles delayed are summarized by the length of delay (\> 3 days, \> 5 days, and \> 7 days) across cycles 2 through 8.
Time frame: Cycles 2 - 8 (approximately 21 days)
Population: Full analysis set participants who received more than 1 cycle of chemotherapy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ovarian | Percentage of Cycles With Chemotherapy Dose Delays | > 7 Days Delay in One or More Cycles | 7 percentage of cycles |
| Ovarian | Percentage of Cycles With Chemotherapy Dose Delays | > 5 Days Delay in One or More Cycles | 16 percentage of cycles |
| Ovarian | Percentage of Cycles With Chemotherapy Dose Delays | > 3 Days Delay in One or More Cycles | 20 percentage of cycles |
| NSCLC | Percentage of Cycles With Chemotherapy Dose Delays | > 7 Days Delay in One or More Cycles | 9 percentage of cycles |
| NSCLC | Percentage of Cycles With Chemotherapy Dose Delays | > 3 Days Delay in One or More Cycles | 24 percentage of cycles |
| NSCLC | Percentage of Cycles With Chemotherapy Dose Delays | > 5 Days Delay in One or More Cycles | 19 percentage of cycles |
| SCLC | Percentage of Cycles With Chemotherapy Dose Delays | > 5 Days Delay in One or More Cycles | 19 percentage of cycles |
| SCLC | Percentage of Cycles With Chemotherapy Dose Delays | > 3 Days Delay in One or More Cycles | 24 percentage of cycles |
| SCLC | Percentage of Cycles With Chemotherapy Dose Delays | > 7 Days Delay in One or More Cycles | 8 percentage of cycles |
| Breast Stage I-III | Percentage of Cycles With Chemotherapy Dose Delays | > 7 Days Delay in One or More Cycles | 2 percentage of cycles |
| Breast Stage I-III | Percentage of Cycles With Chemotherapy Dose Delays | > 5 Days Delay in One or More Cycles | 5 percentage of cycles |
| Breast Stage I-III | Percentage of Cycles With Chemotherapy Dose Delays | > 3 Days Delay in One or More Cycles | 7 percentage of cycles |
| Breast Metastatic | Percentage of Cycles With Chemotherapy Dose Delays | > 3 Days Delay in One or More Cycles | 17 percentage of cycles |
| Breast Metastatic | Percentage of Cycles With Chemotherapy Dose Delays | > 5 Days Delay in One or More Cycles | 14 percentage of cycles |
| Breast Metastatic | Percentage of Cycles With Chemotherapy Dose Delays | > 7 Days Delay in One or More Cycles | 6 percentage of cycles |
| Breast Total | Percentage of Cycles With Chemotherapy Dose Delays | > 5 Days Delay in One or More Cycles | 6 percentage of cycles |
| Breast Total | Percentage of Cycles With Chemotherapy Dose Delays | > 3 Days Delay in One or More Cycles | 8 percentage of cycles |
| Breast Total | Percentage of Cycles With Chemotherapy Dose Delays | > 7 Days Delay in One or More Cycles | 2 percentage of cycles |
Secondary
Percentage of Cycles With Chemotherapy Dose Reductions
A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set participants with actual regimens as planned (17 participants received a different regimen to what was planned and are thus excluded)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ovarian | Percentage of Cycles With Chemotherapy Dose Reductions | 16 percentage of cycles |
| NSCLC | Percentage of Cycles With Chemotherapy Dose Reductions | 13 percentage of cycles |
| SCLC | Percentage of Cycles With Chemotherapy Dose Reductions | 12 percentage of cycles |
| Breast Stage I-III | Percentage of Cycles With Chemotherapy Dose Reductions | 6 percentage of cycles |
| Breast Metastatic | Percentage of Cycles With Chemotherapy Dose Reductions | 16 percentage of cycles |
| Breast Total | Percentage of Cycles With Chemotherapy Dose Reductions | 7 percentage of cycles |
Secondary
Percentage of Participants Who Received ESAs and Achieved Hematopoietic Response
Kaplan-Meier estimate of the percentage of participants in cycles 1 to 8 receiving ESA treatment who achieved a hematopoietic response during the ESA treatment phase, defined as a hemoglobin concentration ≥ 12 g/dL or a ≥ 2 g/dL rise in hemoglobin after starting ESA treatment.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Participants who received treatment with an ESA
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Ovarian | Percentage of Participants Who Received ESAs and Achieved Hematopoietic Response | 45 percentage of participants | 95% Confidence Interval 4.6 |
Secondary
Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 10 g/dL After 5 Weeks ESA Treatment
Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 10 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.
Time frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Population: Participants who received treatment with an ESA, and with hemoglobin \< 10 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Ovarian | Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 10 g/dL After 5 Weeks ESA Treatment | 85 percentage of participants | 95% Confidence Interval 4.6 |
Secondary
Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 11 g/dL After 5 Weeks ESA Treatment
Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 11 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.
Time frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Population: Participants who received treatment with an ESA, and with hemoglobin \< 11 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Ovarian | Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 11 g/dL After 5 Weeks ESA Treatment | 66 percentage of participants | 95% Confidence Interval 4.6 |
Secondary
Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 12 g/dL After 5 Weeks ESA Treatment
Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 12 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.
Time frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Population: Participants who received treatment with an ESA, and with hemoglobin \< 12 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Ovarian | Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 12 g/dL After 5 Weeks ESA Treatment | 35 percentage of participants | 95% Confidence Interval 4.6 |
Secondary
Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 9 g/dL After 5 Weeks ESA Treatment
Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 9 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.
Time frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Population: Participants who received treatment with an ESA and with hemoglobin \< 9 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Ovarian | Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 9 g/dL After 5 Weeks ESA Treatment | 58 percentage of participants | 95% Confidence Interval 4.6 |
Secondary
Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL 9 Weeks After Initiation of ESA Treatment
The percentage of participants achieving a hemoglobin level from 10 to 12 g/dL after 9 weeks of ESA treatment.
Time frame: 9 weeks post initiation of ESA treatment
Population: Participants who received treatment with an ESA
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Ovarian | Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL 9 Weeks After Initiation of ESA Treatment | 15 percentage of participants | 95% Confidence Interval 4.6 |
Secondary
Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL After 5 Weeks ESA Treatment
Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level from 10 to 12 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.
Time frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Population: Participants who received treatment with an ESA, and with hemoglobin \< 10 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Ovarian | Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL After 5 Weeks ESA Treatment | 84 percentage of participants | 95% Confidence Interval 4.6 |
Secondary
Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 12 to 13 g/dL After 5 Weeks ESA Treatment
Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level from 12 to 13 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.
Time frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Population: Participants who received treatment with an ESA, and with hemoglobin \< 12 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Ovarian | Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 12 to 13 g/dL After 5 Weeks ESA Treatment | 30 percentage of participants | 95% Confidence Interval 4.6 |
Secondary
Percentage of Participants Who Received ESAs and Required a Red Blood Cell (RBC) Transfusion After 5 Weeks of ESA Treatment
Kaplan-Meier estimate of the percentage of participants with RBC transfusions from five weeks post initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.
Time frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Population: Participants who received treatment with an ESA and still on study 5 weeks after initiation of ESA treatment.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Ovarian | Percentage of Participants Who Received ESAs and Required a Red Blood Cell (RBC) Transfusion After 5 Weeks of ESA Treatment | 11 percentage of participants | 95% Confidence Interval 4.6 |
Secondary
Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8
A dose delay is defined as a delay of more than 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of participants with delays in chemotherapy administration are summarized by the length of delay (\> 3 days, \> 5 days, and \> 7 days) across cycles 2 through 8.
Time frame: Cycles 2 - 8 (approximately 21 weeks)
Population: Full analysis set participants who received more than 1 cycle of chemotherapy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ovarian | Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 | > 5 Days Delay in One or More Cycles | 39 percentage of participants |
| Ovarian | Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 | > 3 Days Delay in One or More Cycles | 48 percentage of participants |
| Ovarian | Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 | > 7 Days Delay in One or More Cycles | 24 percentage of participants |
| NSCLC | Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 | > 5 Days Delay in One or More Cycles | 39 percentage of participants |
| NSCLC | Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 | > 3 Days Delay in One or More Cycles | 46 percentage of participants |
| NSCLC | Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 | > 7 Days Delay in One or More Cycles | 23 percentage of participants |
| SCLC | Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 | > 5 Days Delay in One or More Cycles | 47 percentage of participants |
| SCLC | Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 | > 3 Days Delay in One or More Cycles | 52 percentage of participants |
| SCLC | Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 | > 7 Days Delay in One or More Cycles | 26 percentage of participants |
| Breast Stage I-III | Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 | > 5 Days Delay in One or More Cycles | 22 percentage of participants |
| Breast Stage I-III | Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 | > 3 Days Delay in One or More Cycles | 29 percentage of participants |
| Breast Stage I-III | Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 | > 7 Days Delay in One or More Cycles | 9 percentage of participants |
| Breast Metastatic | Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 | > 5 Days Delay in One or More Cycles | 40 percentage of participants |
| Breast Metastatic | Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 | > 3 Days Delay in One or More Cycles | 47 percentage of participants |
| Breast Metastatic | Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 | > 7 Days Delay in One or More Cycles | 21 percentage of participants |
| Breast Total | Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 | > 3 Days Delay in One or More Cycles | 31 percentage of participants |
| Breast Total | Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 | > 7 Days Delay in One or More Cycles | 10 percentage of participants |
| Breast Total | Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 | > 5 Days Delay in One or More Cycles | 24 percentage of participants |
Secondary
Percentage of Participants With Chemotherapy Dose Reductions
A participant is considered to have a dose reduction in a given cycle if there was a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set participants with actual regimens as planned (17 participants received a different regimen to what was planned and are thus excluded)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ovarian | Percentage of Participants With Chemotherapy Dose Reductions | 34 percentage of participants |
| NSCLC | Percentage of Participants With Chemotherapy Dose Reductions | 25 percentage of participants |
| SCLC | Percentage of Participants With Chemotherapy Dose Reductions | 22 percentage of participants |
| Breast Stage I-III | Percentage of Participants With Chemotherapy Dose Reductions | 16 percentage of participants |
| Breast Metastatic | Percentage of Participants With Chemotherapy Dose Reductions | 29 percentage of participants |
| Breast Total | Percentage of Participants With Chemotherapy Dose Reductions | 17 percentage of participants |
Secondary
Reason for Treatment With Erythropoiesis-stimulating Agents
The reason treatment with an ESA was initiated as recorded by the investigator; participants may have more than one reason for initiating treatment.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Participants who received treatment with an ESA
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Ovarian | Reason for Treatment With Erythropoiesis-stimulating Agents | Hemoglobin level | 134 participants | 4.6 |
| Ovarian | Reason for Treatment With Erythropoiesis-stimulating Agents | Risk of chemotherapy induced anemia | 10 participants | — |
| Ovarian | Reason for Treatment With Erythropoiesis-stimulating Agents | Evidence based guidelines | 3 participants | — |
| Ovarian | Reason for Treatment With Erythropoiesis-stimulating Agents | Other anemia-related symptoms | 3 participants | — |
Secondary
Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8
A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Population: Full analysis set participants with actual regimens as planned and with ≥ 15% chemotherapy dose reduction in any cycle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ovarian | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Chemotherapy induced anemia | 3 cycles |
| Ovarian | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Other | 16 cycles |
| Ovarian | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Febrile neutropenia | 4 cycles |
| Ovarian | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Hepatic toxicity | 0 cycles |
| Ovarian | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Dose administration error | 1 cycles |
| Ovarian | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Chemotherapy induced neutropenia | 15 cycles |
| Ovarian | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Chemotherapy induced thrombocytopenia | 5 cycles |
| Ovarian | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Gastrointestinal toxicity | 4 cycles |
| Ovarian | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Missing | 36 cycles |
| Ovarian | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Weight loss | 1 cycles |
| Ovarian | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Reduced to assess dose/tolerability | 2 cycles |
| Ovarian | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Other non-hematological reason | 31 cycles |
| Ovarian | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Other hematological reason | 1 cycles |
| Ovarian | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Neurological toxicity | 2 cycles |
| Ovarian | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Participant preference | 2 cycles |
| NSCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Missing | 23 cycles |
| NSCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Neurological toxicity | 2 cycles |
| NSCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Gastrointestinal toxicity | 2 cycles |
| NSCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Other | 19 cycles |
| NSCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Reduced to assess dose/tolerability | 6 cycles |
| NSCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Chemotherapy induced neutropenia | 16 cycles |
| NSCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Participant preference | 0 cycles |
| NSCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Chemotherapy induced anemia | 7 cycles |
| NSCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Dose administration error | 0 cycles |
| NSCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Weight loss | 1 cycles |
| NSCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Chemotherapy induced thrombocytopenia | 4 cycles |
| NSCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Febrile neutropenia | 4 cycles |
| NSCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Other non-hematological reason | 13 cycles |
| NSCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Other hematological reason | 1 cycles |
| NSCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Hepatic toxicity | 1 cycles |
| SCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Weight loss | 5 cycles |
| SCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Febrile neutropenia | 3 cycles |
| SCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Chemotherapy induced neutropenia | 3 cycles |
| SCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Chemotherapy induced anemia | 2 cycles |
| SCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Chemotherapy induced thrombocytopenia | 2 cycles |
| SCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Other hematological reason | 2 cycles |
| SCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Gastrointestinal toxicity | 1 cycles |
| SCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Neurological toxicity | 2 cycles |
| SCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Hepatic toxicity | 2 cycles |
| SCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Other non-hematological reason | 10 cycles |
| SCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Dose administration error | 0 cycles |
| SCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Participant preference | 0 cycles |
| SCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Reduced to assess dose/tolerability | 1 cycles |
| SCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Other | 11 cycles |
| SCLC | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Missing | 27 cycles |
| Breast Stage I-III | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Gastrointestinal toxicity | 12 cycles |
| Breast Stage I-III | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Chemotherapy induced anemia | 2 cycles |
| Breast Stage I-III | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Other non-hematological reason | 33 cycles |
| Breast Stage I-III | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Dose administration error | 1 cycles |
| Breast Stage I-III | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Neurological toxicity | 17 cycles |
| Breast Stage I-III | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Missing | 109 cycles |
| Breast Stage I-III | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Chemotherapy induced neutropenia | 41 cycles |
| Breast Stage I-III | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Participant preference | 0 cycles |
| Breast Stage I-III | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Other | 20 cycles |
| Breast Stage I-III | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Chemotherapy induced thrombocytopenia | 0 cycles |
| Breast Stage I-III | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Febrile neutropenia | 15 cycles |
| Breast Stage I-III | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Hepatic toxicity | 0 cycles |
| Breast Stage I-III | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Weight loss | 0 cycles |
| Breast Stage I-III | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Other hematological reason | 0 cycles |
| Breast Stage I-III | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Reduced to assess dose/tolerability | 6 cycles |
| Breast Metastatic | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Chemotherapy induced neutropenia | 11 cycles |
| Breast Metastatic | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Hepatic toxicity | 0 cycles |
| Breast Metastatic | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Chemotherapy induced thrombocytopenia | 1 cycles |
| Breast Metastatic | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Other non-hematological reason | 8 cycles |
| Breast Metastatic | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Weight loss | 1 cycles |
| Breast Metastatic | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Chemotherapy induced anemia | 0 cycles |
| Breast Metastatic | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Neurological toxicity | 0 cycles |
| Breast Metastatic | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Dose administration error | 2 cycles |
| Breast Metastatic | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Participant preference | 0 cycles |
| Breast Metastatic | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Reduced to assess dose/tolerability | 1 cycles |
| Breast Metastatic | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Febrile neutropenia | 6 cycles |
| Breast Metastatic | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Missing | 35 cycles |
| Breast Metastatic | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Gastrointestinal toxicity | 2 cycles |
| Breast Metastatic | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Other | 10 cycles |
| Breast Metastatic | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Other hematological reason | 0 cycles |
| Breast Total | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Weight loss | 1 cycles |
| Breast Total | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Neurological toxicity | 17 cycles |
| Breast Total | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Reduced to assess dose/tolerability | 7 cycles |
| Breast Total | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Other hematological reason | 0 cycles |
| Breast Total | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Chemotherapy induced anemia | 2 cycles |
| Breast Total | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Hepatic toxicity | 0 cycles |
| Breast Total | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Other non-hematological reason | 41 cycles |
| Breast Total | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Chemotherapy induced thrombocytopenia | 1 cycles |
| Breast Total | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Missing | 144 cycles |
| Breast Total | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Other | 30 cycles |
| Breast Total | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Gastrointestinal toxicity | 14 cycles |
| Breast Total | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Participant preference | 0 cycles |
| Breast Total | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Chemotherapy induced neutropenia | 52 cycles |
| Breast Total | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Febrile neutropenia | 21 cycles |
| Breast Total | Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 | Dose administration error | 3 cycles |
Secondary
Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8
A dose delay is defined as a delay of \> 3 days in the start of chemotherapy measured since the start of the previous cycle.
Time frame: Cycles 2 - 8 (approximately 21 weeks)
Population: Full analysis set participants who received more than 1 cycle of chemotherapy and had \> 3 days delay in one or more cycles
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ovarian | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Gastrointestinal Toxicity | 3 cycles |
| Ovarian | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Febrile Neutropenia | 1 cycles |
| Ovarian | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Neurological Toxicity | 3 cycles |
| Ovarian | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Dose Administration Error | 0 cycles |
| Ovarian | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Other | 24 cycles |
| Ovarian | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Chemotherapy Induced Thrombocytopenia | 7 cycles |
| Ovarian | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Chemotherapy Induced Neutropenia | 27 cycles |
| Ovarian | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Participant Preference | 19 cycles |
| Ovarian | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Other Non-Hematological Reason | 14 cycles |
| Ovarian | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Chemotherapy Induced Anemia | 5 cycles |
| Ovarian | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Hepatic Toxicity | 1 cycles |
| Ovarian | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Other Hematological Reason | 2 cycles |
| Ovarian | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Missing | 18 cycles |
| NSCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Other Hematological Reason | 1 cycles |
| NSCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Neurological Toxicity | 2 cycles |
| NSCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Gastrointestinal Toxicity | 0 cycles |
| NSCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Other | 33 cycles |
| NSCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Chemotherapy Induced Neutropenia | 34 cycles |
| NSCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Missing | 16 cycles |
| NSCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Participant Preference | 19 cycles |
| NSCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Chemotherapy Induced Anemia | 7 cycles |
| NSCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Dose Administration Error | 3 cycles |
| NSCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Other Non-Hematological Reason | 21 cycles |
| NSCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Chemotherapy Induced Thrombocytopenia | 0 cycles |
| NSCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Febrile Neutropenia | 6 cycles |
| NSCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Hepatic Toxicity | 0 cycles |
| SCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Febrile Neutropenia | 6 cycles |
| SCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Chemotherapy Induced Neutropenia | 14 cycles |
| SCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Chemotherapy Induced Anemia | 1 cycles |
| SCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Chemotherapy Induced Thrombocytopenia | 4 cycles |
| SCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Other Hematological Reason | 1 cycles |
| SCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Gastrointestinal Toxicity | 2 cycles |
| SCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Neurological Toxicity | 1 cycles |
| SCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Hepatic Toxicity | 1 cycles |
| SCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Other Non-Hematological Reason | 20 cycles |
| SCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Dose Administration Error | 0 cycles |
| SCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Participant Preference | 15 cycles |
| SCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Other | 34 cycles |
| SCLC | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Missing | 14 cycles |
| Breast Stage I-III | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Gastrointestinal Toxicity | 3 cycles |
| Breast Stage I-III | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Participant Preference | 51 cycles |
| Breast Stage I-III | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Hepatic Toxicity | 4 cycles |
| Breast Stage I-III | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Chemotherapy Induced Anemia | 3 cycles |
| Breast Stage I-III | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Missing | 18 cycles |
| Breast Stage I-III | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Dose Administration Error | 0 cycles |
| Breast Stage I-III | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Neurological Toxicity | 5 cycles |
| Breast Stage I-III | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Other Hematological Reason | 8 cycles |
| Breast Stage I-III | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Other | 78 cycles |
| Breast Stage I-III | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Chemotherapy Induced Thrombocytopenia | 1 cycles |
| Breast Stage I-III | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Chemotherapy Induced Neutropenia | 41 cycles |
| Breast Stage I-III | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Febrile Neutropenia | 12 cycles |
| Breast Stage I-III | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Other Non-Hematological Reason | 44 cycles |
| Breast Metastatic | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Dose Administration Error | 0 cycles |
| Breast Metastatic | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Neurological Toxicity | 3 cycles |
| Breast Metastatic | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Chemotherapy Induced Thrombocytopenia | 1 cycles |
| Breast Metastatic | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Febrile Neutropenia | 3 cycles |
| Breast Metastatic | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Hepatic Toxicity | 0 cycles |
| Breast Metastatic | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Other Non-Hematological Reason | 6 cycles |
| Breast Metastatic | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Chemotherapy Induced Anemia | 0 cycles |
| Breast Metastatic | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Chemotherapy Induced Neutropenia | 9 cycles |
| Breast Metastatic | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Participant Preference | 16 cycles |
| Breast Metastatic | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Missing | 10 cycles |
| Breast Metastatic | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Other | 19 cycles |
| Breast Metastatic | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Gastrointestinal Toxicity | 1 cycles |
| Breast Metastatic | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Other Hematological Reason | 2 cycles |
| Breast Total | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Participant Preference | 67 cycles |
| Breast Total | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Chemotherapy Induced Anemia | 3 cycles |
| Breast Total | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Febrile Neutropenia | 15 cycles |
| Breast Total | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Gastrointestinal Toxicity | 4 cycles |
| Breast Total | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Hepatic Toxicity | 4 cycles |
| Breast Total | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Other Hematological Reason | 10 cycles |
| Breast Total | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Other | 97 cycles |
| Breast Total | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Dose Administration Error | 0 cycles |
| Breast Total | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Chemotherapy Induced Neutropenia | 50 cycles |
| Breast Total | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Chemotherapy Induced Thrombocytopenia | 2 cycles |
| Breast Total | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Missing | 28 cycles |
| Breast Total | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Other Non-Hematological Reason | 50 cycles |
| Breast Total | Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 | Neurological Toxicity | 8 cycles |
Secondary
Time to Disease Progression
Time to disease progression was calculated from cycle 1 day 1 to a date at which disease progression was first recorded. Participants who died due to causes other than disease progression were censored at the date of death. Participants who were alive and whose disease had not progressed at the most recent contact, or who were lost to follow-up, or with missing data, were censored at the date of last contact. Median time to disease progression was estimated from the Kaplan-Meier survival function.
Time frame: From cycle 1, day 1 until end of the long-term follow-up; median time on follow-up from cycle 1, day 1 was 52 months.
Population: Full analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ovarian | Time to Disease Progression | 12.4 months |
| NSCLC | Time to Disease Progression | 6.5 months |
| SCLC | Time to Disease Progression | 6.8 months |
| Breast Stage I-III | Time to Disease Progression | NA months |
| Breast Metastatic | Time to Disease Progression | 11.8 months |
| Breast Total | Time to Disease Progression | NA months |