Trial Outcomes & Findings for SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide (NCT NCT02953340)
NCT ID: NCT02953340
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 per liter \[L\]) from the first occurrence of ANC below the threshold.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
237 participants
Primary outcome timeframe
Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
Results posted on
2022-03-02
Participant Flow
This study was conducted at 74 sites in the United States, Canada, Hungary, Poland, India, Korea from 10 May 2017 to 06 May 2019. The study was conducted in two periods: treatment period (first dose of TC until 35 (± 5) days after last dose of treatment) and safety follow-up period (End of Treatment Visit through 12 months after last dose of study treatment).
A total of 237 participants were randomized into study, 118 participants in Arm 1 (SPI-2012 and TC) and 119 participants in Arm 2 (Pegfilgrastim and TC). 235 participants were treated, out of which 181 participants completed the study. All participants who received at least one dose of study drug (treatment period) entered the safety follow-up period.
Participant milestones
| Measure |
(Arm 1): SPI-2012 and TC
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 milligrams (mg)/0.6 milliliter (mL), \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] subcutaneously (SC) approximately 24-26 hours after receiving intravenous (IV) infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(Arm 2): Pegfilgrastim and TC
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL GCSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
118
|
119
|
|
Overall Study
Safety Population
|
117
|
118
|
|
Overall Study
Entered Safety Follow-up Period
|
117
|
118
|
|
Overall Study
COMPLETED
|
96
|
85
|
|
Overall Study
NOT COMPLETED
|
22
|
34
|
Reasons for withdrawal
| Measure |
(Arm 1): SPI-2012 and TC
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 milligrams (mg)/0.6 milliliter (mL), \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] subcutaneously (SC) approximately 24-26 hours after receiving intravenous (IV) infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(Arm 2): Pegfilgrastim and TC
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL GCSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Investigator Decision
|
3
|
3
|
|
Overall Study
Initiated Non-Protocol Therapy
|
5
|
14
|
|
Overall Study
Myeloid Growth Factors Treatment
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
9
|
|
Overall Study
Sponsor decision
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Reason not specified
|
2
|
2
|
Baseline Characteristics
SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide
Baseline characteristics by cohort
| Measure |
(Arm 1): SPI-2012 and TC
n=118 Participants
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(Arm 2): Pegfilgrastim and TC
n=119 Participants
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
Total
n=237 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=93 Participants
|
104 Participants
n=4 Participants
|
204 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
85 Participants
n=93 Participants
|
96 Participants
n=4 Participants
|
181 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
11 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 11.27 • n=93 Participants
|
58.1 years
STANDARD_DEVIATION 12.67 • n=4 Participants
|
58.0 years
STANDARD_DEVIATION 11.97 • n=27 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=93 Participants
|
119 Participants
n=4 Participants
|
237 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
20 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)Population: 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 per liter \[L\]) from the first occurrence of ANC below the threshold.
Outcome measures
| Measure |
(Arm 1): SPI-2012 and TC
n=118 Participants
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(Arm 2): Pegfilgrastim and TC
n=119 Participants
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(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 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 study treatment
|
|---|---|---|---|---|
|
Duration of Severe Neutropenia (DSN) in Cycle 1
|
0.31 Days
Standard Deviation 0.688
|
0.39 Days
Standard Deviation 0.949
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)Population: ITT population included all participants who were randomized.
Time to ANC recovery was defined as the time from chemotherapy administration until the participants ANC increased to \>=1.5×10\^9/L after the expected nadir. For participants with ANC value \>=1.5×10\^9/L at all times, time to ANC Recovery was assigned a value of 0.
Outcome measures
| Measure |
(Arm 1): SPI-2012 and TC
n=118 Participants
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(Arm 2): Pegfilgrastim and TC
n=119 Participants
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(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 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 study treatment
|
|---|---|---|---|---|
|
Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1
|
3.49 Days
Standard Deviation 3.723
|
3.35 Days
Standard Deviation 3.745
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)Population: ITT population included all participants who were randomized. Here 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure at the specified timepoint.
The 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
| Measure |
(Arm 1): SPI-2012 and TC
n=115 Participants
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(Arm 2): Pegfilgrastim and TC
n=116 Participants
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(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 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 study treatment
|
|---|---|---|---|---|
|
Depth of ANC Nadir in Cycle 1
|
2.67 10^9 cells/L
Standard Deviation 3.504
|
2.06 10^9 cells/L
Standard Deviation 2.034
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)Population: ITT population included all participants who were randomized.
FN was defined as an oral temperature \>38.3 degree Celsius (°C) (101.0 degrees Fahrenheit \[°F\]) or two consecutive readings of \>38.0°C (100.4°F) for 2 hours and ANC \<1.0×10\^9/L.
Outcome measures
| Measure |
(Arm 1): SPI-2012 and TC
n=118 Participants
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(Arm 2): Pegfilgrastim and TC
n=119 Participants
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(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 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 study treatment
|
|---|---|---|---|---|
|
Number of Participants With Febrile Neutropenia (FN) in Cycle 1
|
1 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days)Population: 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 ANC below the threshold.
Outcome measures
| Measure |
(Arm 1): SPI-2012 and TC
n=118 Participants
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(Arm 2): Pegfilgrastim and TC
n=119 Participants
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(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 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 study treatment
|
|---|---|---|---|---|
|
Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4
Cycle 2
|
0.08 Days
Standard Deviation 0.267
|
0.09 Days
Standard Deviation 0.432
|
—
|
—
|
|
Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4
Cycle 3
|
0.07 Days
Standard Deviation 0.252
|
0.07 Days
Standard Deviation 0.283
|
—
|
—
|
|
Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4
Cycle 4
|
0.07 Days
Standard Deviation 0.252
|
0.08 Days
Standard Deviation 0.266
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)Population: ITT population included all participants who were randomized.
Neutropenic complications refer to hospitalizations due to neutropenic events and/or the use of anti-infectives due to neutropenia.
Outcome measures
| Measure |
(Arm 1): SPI-2012 and TC
n=118 Participants
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(Arm 2): Pegfilgrastim and TC
n=119 Participants
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(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 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 study treatment
|
|---|---|---|---|---|
|
Number of Participants With Neutropenic Complications in Cycle 1
|
1 Participants
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days)Population: ITT population included all participants who were randomized.
FN was defined as an oral temperature \>38.3°C (101.0°F) or two consecutive readings of \>38.0°C (100.4°F) for 2 hours and ANC \<1.0×10\^9/L.
Outcome measures
| Measure |
(Arm 1): SPI-2012 and TC
n=118 Participants
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(Arm 2): Pegfilgrastim and TC
n=119 Participants
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(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 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 study treatment
|
|---|---|---|---|---|
|
Number of Participants With Febrile Neutropenia in Cycles 2, 3 and 4
Cycle 2
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Febrile Neutropenia in Cycles 2, 3 and 4
Cycle 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Febrile Neutropenia in Cycles 2, 3 and 4
Cycle 4
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycles 1, 2, 3 and 4 (each cycle = 21 days)Population: Safety analysis (SAF) population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim).
RDI was defined as the percentage of the planned dose of TC chemotherapy that each participant actually received during the study, and is expressed as the total dose received, divided by total dose planned 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
| Measure |
(Arm 1): SPI-2012 and TC
n=117 Participants
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(Arm 2): Pegfilgrastim and TC
n=118 Participants
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(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 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 study treatment
|
|---|---|---|---|---|
|
Relative Dose Intensity (RDI) of TC Chemotherapy
Docetaxel
|
96.9 Percentage of planned dose
Standard Deviation 7.70
|
98.4 Percentage of planned dose
Standard Deviation 7.89
|
—
|
—
|
|
Relative Dose Intensity (RDI) of TC Chemotherapy
Cyclophosphamide
|
98.4 Percentage of planned dose
Standard Deviation 5.27
|
98.8 Percentage of planned dose
Standard Deviation 6.40
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)Population: SAF population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Data was summarized and reported for Treatment and Follow-up period separately for both groups.
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 is any AE that occurred from the first dose of study treatment through 12 months after the last dose of study treatment or 35 (±5) days after date of participant early discontinuation. 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
| Measure |
(Arm 1): SPI-2012 and TC
n=117 Participants
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(Arm 2): Pegfilgrastim and TC
n=118 Participants
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(Arm 1): SPI-2012 and TC: Follow-up Period
n=117 Participants
In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment.
|
Arm 2: Pegfilgrastim and TC: Follow-up Period
n=118 Participants
In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death
TEAEs
|
115 Participants
|
116 Participants
|
33 Participants
|
48 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death
SAEs
|
12 Participants
|
19 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death
Death
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)Population: SAF population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim).
The number of participants with clinically significant hematology (including basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, hematocrit, hemoglobin, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils, neutrophils/leukocytes, platelets, and white blood cells) and serum chemistry (including alanine aminotransferase \[ALT\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin, calcium, cholesterol, creatinine, potassium, sodium, and triglycerides) laboratory abnormalities were reported. Clinically significant findings in laboratory parameters were based on investigator's discretion according to Common Technical Criteria for Adverse Events (CTCAE) Version 4.03.
Outcome measures
| Measure |
(Arm 1): SPI-2012 and TC
n=117 Participants
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(Arm 2): Pegfilgrastim and TC
n=118 Participants
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
|
(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 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 study treatment
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Chemistry: Cholesterol
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Hematology: Basophils
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Hematology: Basophils/Leukocytes
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Hematology: Eosinophils
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Hematology: Eosinophils/Leukocytes
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Hematology: Hematocrit
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Hematology: Hemoglobin
|
6 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Hematology: Lymphocytes
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Hematology: Lymphocytes/Leukocytes
|
6 Participants
|
13 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Hematology: Monocytes
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Hematology: Monocytes/Leukocytes
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Hematology: Neutrophils
|
17 Participants
|
23 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Hematology: Neutrophils/Leukocytes
|
12 Participants
|
9 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Hematology: Platelets
|
10 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Hematology: White Blood Cells
|
16 Participants
|
18 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Chemistry: Alanine aminotransferase
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Chemistry: Alkaline phosphatase
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Chemistry: Aspartate aminotransferase
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Chemistry: Bilirubin
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Chemistry: Calcium
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Chemistry: Creatinine
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Chemistry: Potassium
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Chemistry: Sodium
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Chemistry: Triglycerides
|
0 Participants
|
0 Participants
|
—
|
—
|
Adverse Events
(Arm 1): SPI-2012 and TC
Serious events: 12 serious events
Other events: 115 other events
Deaths: 0 deaths
(Arm 2): Pegfilgrastim and TC
Serious events: 19 serious events
Other events: 116 other events
Deaths: 1 deaths
(Arm 1): SPI-2012 and TC: Follow-up Period
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
(Arm 2): Pegfilgrastim and TC: Follow-up Period
Serious events: 4 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
(Arm 1): SPI-2012 and TC
n=117 participants at risk
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg / 0.6 mL, \[3.6 mg G-CSF\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.
|
(Arm 2): Pegfilgrastim and TC
n=118 participants at risk
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.
|
(Arm 1): SPI-2012 and TC: Follow-up Period
n=117 participants at risk
In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment.
|
(Arm 2): Pegfilgrastim and TC: Follow-up Period
n=118 participants at risk
In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment.
|
|---|---|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Vascular disorders
Hypotension
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
General disorders
Administration site reaction
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
General disorders
Chest pain
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
General disorders
Pyrexia
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
2/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
1.7%
2/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
2.5%
3/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
1.7%
2/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Nervous system disorders
Syncope
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Gastrointestinal disorders
Nausea
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Gastrointestinal disorders
Vomiting
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Infections and infestations
Bronchitis
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Infections and infestations
Chest wall abscess
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Infections and infestations
Cystitis
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Infections and infestations
Enterocolitis infectious
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Infections and infestations
Herpes zoster
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
1.7%
2/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Infections and infestations
Pyelonephritis
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Infections and infestations
Sepsis
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
Other adverse events
| Measure |
(Arm 1): SPI-2012 and TC
n=117 participants at risk
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg / 0.6 mL, \[3.6 mg G-CSF\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.
|
(Arm 2): Pegfilgrastim and TC
n=118 participants at risk
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.
|
(Arm 1): SPI-2012 and TC: Follow-up Period
n=117 participants at risk
In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment.
|
(Arm 2): Pegfilgrastim and TC: Follow-up Period
n=118 participants at risk
In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment.
|
|---|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
15.4%
18/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
9.3%
11/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Vascular disorders
Flushing
|
7.7%
9/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
8.5%
10/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
1.7%
2/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Vascular disorders
Hot flush
|
8.5%
10/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
6.8%
8/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
2.5%
3/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Vascular disorders
Hypertension
|
3.4%
4/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
6.8%
8/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
2.5%
3/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Vascular disorders
Hypotension
|
5.1%
6/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
2.5%
3/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
General disorders
Fatigue
|
34.2%
40/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
43.2%
51/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
General disorders
Pyrexia
|
21.4%
25/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
22.0%
26/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
General disorders
Oedema peripheral
|
10.3%
12/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
12.7%
15/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
1.7%
2/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
1.7%
2/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
General disorders
Asthenia
|
12.8%
15/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
9.3%
11/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
General disorders
Pain
|
4.3%
5/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
9.3%
11/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
General disorders
Chills
|
3.4%
4/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
5.1%
6/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
General disorders
Malaise
|
2.6%
3/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
5.1%
6/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Psychiatric disorders
Anxiety
|
4.3%
5/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
6.8%
8/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Investigations
Lymphocyte count decreased
|
37.6%
44/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
45.8%
54/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Investigations
White blood cell count decreased
|
18.8%
22/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
26.3%
31/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
1.7%
2/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Investigations
Neutrophil count decreased
|
13.7%
16/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
18.6%
22/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Investigations
Platelet count decreased
|
10.3%
12/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
2.5%
3/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Investigations
White blood cell count increased
|
7.7%
9/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
2.5%
3/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Cardiac disorders
Tachycardia
|
4.3%
5/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
5.1%
6/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Blood and lymphatic system disorders
Neutropenia
|
31.6%
37/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
31.4%
37/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Blood and lymphatic system disorders
Anaemia
|
18.8%
22/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
9.3%
11/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
1.7%
2/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.5%
10/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
7.6%
9/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.8%
8/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
14.4%
17/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
1.7%
2/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.8%
8/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
11.9%
14/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.7%
9/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
8.5%
10/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.4%
4/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
5.9%
7/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Nervous system disorders
Headache
|
26.5%
31/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
29.7%
35/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Nervous system disorders
Dysgeusia
|
7.7%
9/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
13.6%
16/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.7%
9/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
11.9%
14/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Nervous system disorders
Dizziness
|
5.1%
6/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
10.2%
12/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Eye disorders
Lacrimation increased
|
1.7%
2/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
5.9%
7/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Gastrointestinal disorders
Nausea
|
42.7%
50/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
51.7%
61/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Gastrointestinal disorders
Diarrhoea
|
32.5%
38/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
33.9%
40/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
2.5%
3/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
26/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
20.3%
24/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
1.7%
2/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
14/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
16.9%
20/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
1.7%
2/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
14/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
16.1%
19/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.0%
14/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
7.6%
9/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Gastrointestinal disorders
Stomatitis
|
7.7%
9/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
8.5%
10/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Gastrointestinal disorders
Dry mouth
|
2.6%
3/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
7.6%
9/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
34.2%
40/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
36.4%
43/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
13/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
9.3%
11/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.5%
10/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
7.6%
9/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
1.7%
2/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.4%
4/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
5.1%
6/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
40.2%
47/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
43.2%
51/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.2%
26/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
19.5%
23/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
2.5%
3/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
18/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
12.7%
15/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
1.7%
2/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
2.5%
3/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.5%
17/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
10.2%
12/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
3.4%
4/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
5.9%
7/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.0%
14/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
9.3%
11/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.7%
23/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
16.1%
19/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.4%
4/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
6.8%
8/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
1.7%
2/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
1.7%
2/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
3/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
6.8%
8/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
5/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
7.6%
9/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
1.7%
2/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
3/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
5.1%
6/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Infections and infestations
Urinary tract infection
|
2.6%
3/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
5.9%
7/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
2.5%
3/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Infections and infestations
Candida infection
|
0.85%
1/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
5.9%
7/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
0.00%
0/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
1.7%
2/117 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
5.1%
6/118 • Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
|
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