Trial Outcomes & Findings for SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE) (NCT NCT02643420)

Last Updated: 2022-03-02

Results Overview

DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \[ANC\] \<0.5×10\^9/L), after the administration of study drug in Cycle 1.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

406 participants

Primary outcome timeframe

Day 1 and Days 4-15 in Cycle 1 (each cycle was 21 days)

Results posted on

2022-03-02

Participant Flow

Participants were enrolled from 19 Jan 2016 to 31 Oct 2018. A total of 406 participants were randomized in the study.

Participant milestones

Participant milestones
Measure	Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC) Participants received SPI-2012 13.2 milligram (mg)/0.6 milliliter (mL) (3.6 mg Granulocyte Colony-Stimulating Factor \[G-CSF\]) fixed-dose subcutaneous (SC) injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 intravenous (IV) infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC) Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.
Overall Study STARTED	196	210
Overall Study Safety Population	197	208
Overall Study COMPLETED	142	145
Overall Study NOT COMPLETED	54	65

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC) Participants received SPI-2012 13.2 milligram (mg)/0.6 milliliter (mL) (3.6 mg Granulocyte Colony-Stimulating Factor \[G-CSF\]) fixed-dose subcutaneous (SC) injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 intravenous (IV) infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC) Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.
Overall Study Initiation of Non-Protocol Therapy for Breast Cancer	6	12
Overall Study Withdrawal by Subject	25	19
Overall Study Treatment with Additional Myeloid Growth Factors During Follow-up	6	10
Overall Study Lost to Follow-up	6	10
Overall Study Investigator Decision	2	4
Overall Study Sponsor decision	1	1
Overall Study Death	0	2
Overall Study Reason not Specified	8	7

Baseline Characteristics

SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: SPI-2012 and TC n=196 Participants Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 2: Pegfilgrastim and TC n=210 Participants Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Total n=406 Participants Total of all reporting groups
Age, Continuous	59.9 years STANDARD_DEVIATION 11.12 • n=5 Participants	59.0 years STANDARD_DEVIATION 11.79 • n=7 Participants	59.5 years STANDARD_DEVIATION 11.47 • n=5 Participants
Sex: Female, Male Female	195 Participants n=5 Participants	209 Participants n=7 Participants	404 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=5 Participants	40 Participants n=7 Participants	74 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	162 Participants n=5 Participants	170 Participants n=7 Participants	332 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	156 Participants n=5 Participants	159 Participants n=7 Participants	315 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	26 Participants n=5 Participants	32 Participants n=7 Participants	58 Participants n=5 Participants
Race/Ethnicity, Customized Asian	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 and Days 4-15 in Cycle 1 (each cycle was 21 days)

Population: The ITT population included all participants who were randomized.

DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \[ANC\] \<0.5×10\^9/L), after the administration of study drug in Cycle 1.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 and TC n=196 Participants Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 2: Pegfilgrastim and TC n=210 Participants Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 1: SPI-2012 and TC - Follow up Period In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.	Arm 2: Pegfilgrastim and TC - Follow up Period In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.
Duration of Severe Neutropenia (DSN) in Cycle 1	0.20 days Standard Deviation 0.503	0.35 days Standard Deviation 0.683	—	—

SECONDARY outcome

Timeframe: Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)

Population: The ITT population included all participants who were randomized.

Time to ANC Recovery was defined as the time from chemotherapy administration until ANC increased to ≥1.5×10\^9/L after the expected nadir within Cycle 1. Time to ANC recovery was assigned as 0 for participants whose ANC value never dropped below 1.5 x10\^9/L.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 and TC n=196 Participants Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 2: Pegfilgrastim and TC n=210 Participants Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 1: SPI-2012 and TC - Follow up Period In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.	Arm 2: Pegfilgrastim and TC - Follow up Period In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.
Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1	3.24 days Standard Deviation 3.565	3.49 days Standard Deviation 3.589	—	—

SECONDARY outcome

Timeframe: Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)

Population: The ITT population included all participants who were randomized. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

Depth of ANC Nadir was defined as the lowest ANC value after administration of study drug (SPI-2012 or Pegfilgrastim) in Cycle 1.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 and TC n=191 Participants Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 2: Pegfilgrastim and TC n=196 Participants Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 1: SPI-2012 and TC - Follow up Period In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.	Arm 2: Pegfilgrastim and TC - Follow up Period In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.
Depth of Absolute Neutrophil Count (ANC) Nadir in Cycle 1	2.56 10^9 ANC/L Standard Deviation 3.086	2.53 10^9 ANC/L Standard Deviation 3.317	—	—

SECONDARY outcome

Timeframe: Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)

Population: The ITT population included all participants who were randomized.

FN was defined as an oral temperature \> 38.3 degrees Celsius (C) (101.0 degrees Fahrenheit \[F\]) or two consecutive readings of \>=38.0 degrees C (100.4 degrees F) for 2 hours and ANC \<1.0×10\^9/L.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 and TC n=196 Participants Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 2: Pegfilgrastim and TC n=210 Participants Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 1: SPI-2012 and TC - Follow up Period In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.	Arm 2: Pegfilgrastim and TC - Follow up Period In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.
Number of Participants With Febrile Neutropenia (FN) in Cycle 1	4 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: Days 1, 4, 7, 10, and 15 in cycles 2, 3, and 4 (each cycle was 21 days)

Population: The ITT population included all participants who were randomized.

DSN was defined as the number of days of severe neutropenia (ANC \<0.5×10\^9 /L) from the first occurrence of an ANC below the threshold in Cycles 2, 3, and 4.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 and TC n=196 Participants Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 2: Pegfilgrastim and TC n=210 Participants Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 1: SPI-2012 and TC - Follow up Period In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.	Arm 2: Pegfilgrastim and TC - Follow up Period In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.
Duration of Severe Neutropenia in Cycle 2, 3 and 4 Cycle 2	0.13 days Standard Deviation 0.383	0.09 days Standard Deviation 0.374	—	—
Duration of Severe Neutropenia in Cycle 2, 3 and 4 Cycle 3	0.11 days Standard Deviation 0.326	0.08 days Standard Deviation 0.273	—	—
Duration of Severe Neutropenia in Cycle 2, 3 and 4 Cycle 4	0.11 days Standard Deviation 0.362	0.09 days Standard Deviation 0.281	—	—

SECONDARY outcome

Timeframe: Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)

Population: The ITT population included all participants who was randomized.

Neutropenic complications refer to hospitalizations due to neutropenic events and/or the use of anti-infectives due to neutropenia.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 and TC n=196 Participants Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 2: Pegfilgrastim and TC n=210 Participants Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 1: SPI-2012 and TC - Follow up Period In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.	Arm 2: Pegfilgrastim and TC - Follow up Period In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.
Number of Participants With Neutropenic Complications in Cycle 1	8 Participants	8 Participants	—	—

SECONDARY outcome

Timeframe: Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle was 21 days)

Population: The ITT population included all participants who were randomized

FN was defined as an oral temperature \> 38.3 degrees C (101.0 degrees Fahrenheit \[F\]) or two consecutive readings of \>=38.0 degrees C (100.4 degrees F) for 2 hours and ANC \<1.0×10\^9/L.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 and TC n=196 Participants Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 2: Pegfilgrastim and TC n=210 Participants Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 1: SPI-2012 and TC - Follow up Period In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.	Arm 2: Pegfilgrastim and TC - Follow up Period In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.
Number of Participants With Febrile Neutropenia in Cycles 2, 3, and 4 Cycle 2	1 Participants	1 Participants	—	—
Number of Participants With Febrile Neutropenia in Cycles 2, 3, and 4 Cycle 3	4 Participants	1 Participants	—	—
Number of Participants With Febrile Neutropenia in Cycles 2, 3, and 4 Cycle 4	2 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Cycles 1 to 4 (each cycle was 21 days)

Population: Safety Population included all participants who received at least one dose of any protocol-specified drug (TC, SPI-2012 or pegfilgrastim). One participant was randomized to pegfilgrastim but was given SPI-2012 in Safety Population.

RDI was defined as the percentage of the planned dose that each participant actually received during the study, expressed as the total dose received, divided by the total dose planned and multiplied by 100. The planned dose was defined as the dose that would be given if no doses were missed and/or no dose reductions were made for the number of cycles started. The total planned dose was the sum of planned doses over all cycles.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 and TC n=197 Participants Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 2: Pegfilgrastim and TC n=208 Participants Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 1: SPI-2012 and TC - Follow up Period In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.	Arm 2: Pegfilgrastim and TC - Follow up Period In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.
Relative Dose Intensity (RDI) of TC (Docetaxel + Cyclophosphamide) in Cycles 1 to 4 Cyclophosphamide	99.3 percentage of planned dose Standard Deviation 3.86	99.0 percentage of planned dose Standard Deviation 4.33	—	—
Relative Dose Intensity (RDI) of TC (Docetaxel + Cyclophosphamide) in Cycles 1 to 4 Docetaxel	99.1 percentage of planned dose Standard Deviation 5.47	98.1 percentage of planned dose Standard Deviation 8.45	—	—

SECONDARY outcome

Timeframe: From the first dose of TC (Docetaxel + Cyclophosphamide) until 12 months after the last dose of study treatment (up to approximately 34 months)

An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product or study procedure, whether or not considered related to the medicinal product. A TEAE for Treatment Period is defined as adverse event with an onset date on or after the date of study drug administration through the end of treatment. TEAE for follow up is defined as any new onset or ongoing AE at the end of Treatment. SAE is defined as any AE which meets any of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, includes important medical events.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 and TC n=197 Participants Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 2: Pegfilgrastim and TC n=208 Participants Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.	Arm 1: SPI-2012 and TC - Follow up Period n=197 Participants In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.	Arm 2: Pegfilgrastim and TC - Follow up Period n=208 Participants In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAE	192 Participants	204 Participants	95 Participants	83 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAE	36 Participants	29 Participants	8 Participants	2 Participants

Adverse Events

Arm 1: SPI-2012 and TC -Treatment Period

Serious events: 36 serious events

Other events: 192 other events

Deaths: 0 deaths

Arm 2: Pegfilgrastim and TC -Treatment Period

Serious events: 29 serious events

Other events: 203 other events

Deaths: 1 deaths

Arm 1: SPI-2012 and TC - Follow up Period

Serious events: 8 serious events

Other events: 92 other events

Deaths: 0 deaths

Arm 2: Pegfilgrastim and TC - Follow up Period

Serious events: 2 serious events

Other events: 82 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Shanta Chawla

Spectrum Pharmaceuticals, Inc, Research and Development Office 157 Technology Drive Irvine, CA 92618

Phone: (949) 788-6700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place