Trial Outcomes & Findings for Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta® (NCT NCT01735175)
NCT ID: NCT01735175
Last Updated: 2017-08-07
Results Overview
Mean duration of severe neutropenia, defined as number of consecutive days with ANC \<0.5 × 10\^9 cells/L (grade 4 neutropenia).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
316 participants
Primary outcome timeframe
21 days (Cycle 1 of chemotherapy treatment)
Results posted on
2017-08-07
Participant Flow
Participant milestones
| Measure |
LA-EP2006
During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
Neulasta®
During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
|---|---|---|
|
Overall Study
STARTED
|
159
|
157
|
|
Overall Study
Completed All Cycles
|
141
|
150
|
|
Overall Study
Completed All Treatments as Planned
|
140
|
150
|
|
Overall Study
Completed the 6-month SFU Visit
|
120
|
138
|
|
Overall Study
COMPLETED
|
130
|
144
|
|
Overall Study
NOT COMPLETED
|
29
|
13
|
Reasons for withdrawal
| Measure |
LA-EP2006
During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
Neulasta®
During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Other (mostly EOS/EOT visit missing)
|
13
|
7
|
Baseline Characteristics
BMI is missing for 1 patient allocated to Neulasta®
Baseline characteristics by cohort
| Measure |
LA-EP2006
n=159 Participants
During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
Neulasta®
n=157 Participants
During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
Total
n=316 Participants
Total of all reporting groups
|
|---|---|---|---|
|
ECOG performance status
1 (restricted in physically strenuous activity)
|
31 Participants
n=159 Participants
|
34 Participants
n=157 Participants
|
65 Participants
n=316 Participants
|
|
Age, Continuous
|
49.9 years
STANDARD_DEVIATION 9.53 • n=159 Participants
|
50.5 years
STANDARD_DEVIATION 10.87 • n=157 Participants
|
50.2 years
STANDARD_DEVIATION 10.20 • n=316 Participants
|
|
Sex: Female, Male
Female
|
159 Participants
n=159 Participants
|
157 Participants
n=157 Participants
|
316 Participants
n=316 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=159 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=316 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=159 Participants
|
18 Participants
n=157 Participants
|
29 Participants
n=316 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
148 Participants
n=159 Participants
|
139 Participants
n=157 Participants
|
287 Participants
n=316 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=159 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=316 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=159 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=316 Participants
|
|
Race (NIH/OMB)
Asian
|
28 Participants
n=159 Participants
|
26 Participants
n=157 Participants
|
54 Participants
n=316 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=159 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=316 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=159 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=316 Participants
|
|
Race (NIH/OMB)
White
|
129 Participants
n=159 Participants
|
127 Participants
n=157 Participants
|
256 Participants
n=316 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=159 Participants
|
4 Participants
n=157 Participants
|
6 Participants
n=316 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=159 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=316 Participants
|
|
BMI
|
27.47 kg/m^2
STANDARD_DEVIATION 26.76 • n=159 Participants • BMI is missing for 1 patient allocated to Neulasta®
|
27.44 kg/m^2
STANDARD_DEVIATION 26.35 • n=156 Participants • BMI is missing for 1 patient allocated to Neulasta®
|
27.45 kg/m^2
STANDARD_DEVIATION 26.40 • n=315 Participants • BMI is missing for 1 patient allocated to Neulasta®
|
|
Time since diagnosis
|
1.35 months
n=153 Participants • For 6 patients in the LA-EP2006 treatment group and 10 patients in the Neulasta® treatment group, the date of initial diagnosis was incomplete.
|
1.38 months
n=147 Participants • For 6 patients in the LA-EP2006 treatment group and 10 patients in the Neulasta® treatment group, the date of initial diagnosis was incomplete.
|
1.38 months
n=300 Participants • For 6 patients in the LA-EP2006 treatment group and 10 patients in the Neulasta® treatment group, the date of initial diagnosis was incomplete.
|
|
Disease stage
I
|
4 Participants
n=159 Participants
|
3 Participants
n=157 Participants
|
7 Participants
n=316 Participants
|
|
Disease stage
II
|
74 Participants
n=159 Participants
|
73 Participants
n=157 Participants
|
147 Participants
n=316 Participants
|
|
Disease stage
III
|
81 Participants
n=159 Participants
|
78 Participants
n=157 Participants
|
159 Participants
n=316 Participants
|
|
Disease stage
IV
|
0 Participants
n=159 Participants
|
3 Participants
n=157 Participants
|
3 Participants
n=316 Participants
|
|
Previous breast cancer surgery
|
149 Participants
n=159 Participants
|
146 Participants
n=157 Participants
|
295 Participants
n=316 Participants
|
|
Previous radiotherapy
|
7 Participants
n=159 Participants
|
9 Participants
n=157 Participants
|
16 Participants
n=316 Participants
|
|
ECOG performance status
0 (fully active)
|
128 Participants
n=159 Participants
|
123 Participants
n=157 Participants
|
251 Participants
n=316 Participants
|
PRIMARY outcome
Timeframe: 21 days (Cycle 1 of chemotherapy treatment)Population: FAS set = full analysis set; PP set = per protocol set
Mean duration of severe neutropenia, defined as number of consecutive days with ANC \<0.5 × 10\^9 cells/L (grade 4 neutropenia).
Outcome measures
| Measure |
LA-EP2006
n=159 Participants
During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
Neulasta®
n=157 Participants
During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
|---|---|---|
|
Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy
FAS
|
0.75 days
Standard Deviation 0.878
|
0.83 days
Standard Deviation 0.898
|
|
Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy
PP
|
0.75 days
Standard Deviation 0.875
|
0.79 days
Standard Deviation 0.872
|
SECONDARY outcome
Timeframe: across all cycles (18 weeks)Population: Number of patients with at least one episode of febrile neutropenia by cycle and across all cycles (FAS set)
FN was defined as an oral temperature ≥ 38.3°C while having an absolute neutrophil count (ANC) \< 0.5 × 10\^9 cells/L. Serious treatment-emergent adverse events (TEAEs) were reconciled with the fever and ANC results recorded in the patient diary and CRF and therefore only the serious TEAEs of FN ("febrile neutropenia", "neutropenic sepsis") were taken into account.
Outcome measures
| Measure |
LA-EP2006
n=159 Participants
During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
Neulasta®
n=157 Participants
During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
|---|---|---|
|
Incidence of Febrile Neutropenia (FN)
Cycle 1
|
6 Participants
|
11 Participants
|
|
Incidence of Febrile Neutropenia (FN)
Cycle 2
|
2 Participants
|
1 Participants
|
|
Incidence of Febrile Neutropenia (FN)
Cycle 3
|
2 Participants
|
1 Participants
|
|
Incidence of Febrile Neutropenia (FN)
Cycle 4
|
1 Participants
|
0 Participants
|
|
Incidence of Febrile Neutropenia (FN)
Cycle 5
|
2 Participants
|
0 Participants
|
|
Incidence of Febrile Neutropenia (FN)
Cycle 6
|
1 Participants
|
1 Participants
|
|
Incidence of Febrile Neutropenia (FN)
All cycles (at least on incidence)
|
9 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: across al cycles (18 weeks)Population: Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set
Fever was defined as an oral temperature ≥ 38.3°C. Fever episodes were characterized by maximum oral temperature and the number of patients who had fever at least once.
Outcome measures
| Measure |
LA-EP2006
n=159 Participants
During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
Neulasta®
n=157 Participants
During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
|---|---|---|
|
Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles
Cycle 1
|
9 Participants
|
14 Participants
|
|
Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles
Cycle 2
|
6 Participants
|
2 Participants
|
|
Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles
Cycle 3
|
7 Participants
|
6 Participants
|
|
Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles
Cycle 4
|
5 Participants
|
2 Participants
|
|
Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles
Cycle 5
|
7 Participants
|
4 Participants
|
|
Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles
Cycle 6
|
5 Participants
|
3 Participants
|
|
Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles
Overall
|
26 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 (3 weeks)Population: FAS set = full analysis set
The depth of ANC nadir was defined as the patient's lowest ANC (10\^9 cells/L) in Cycle 1. Only the evaluable patients with a depth of ANC in Cycle 1 are given.
Outcome measures
| Measure |
LA-EP2006
n=156 Participants
During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
Neulasta®
n=155 Participants
During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
|---|---|---|
|
Depth of ANC Nadir in Cycle 1
|
1.102 10^9 cells/L
Standard Deviation 1.5398
|
0.921 10^9 cells/L
Standard Deviation 1.1771
|
SECONDARY outcome
Timeframe: Cycle 1 (3 weeks)Population: FAS set = full analysis set
Numbers of patients with ANC nadir based per day during Cycle 1 are given.
Outcome measures
| Measure |
LA-EP2006
n=159 Participants
During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
Neulasta®
n=157 Participants
During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
|---|---|---|
|
Number of Patients With ANC Nadir Per Day in Cycle 1
Days 1-5
|
5 Participants
|
5 Participants
|
|
Number of Patients With ANC Nadir Per Day in Cycle 1
Day 6
|
7 Participants
|
4 Participants
|
|
Number of Patients With ANC Nadir Per Day in Cycle 1
Day 7
|
101 Participants
|
104 Participants
|
|
Number of Patients With ANC Nadir Per Day in Cycle 1
Day 8
|
34 Participants
|
25 Participants
|
|
Number of Patients With ANC Nadir Per Day in Cycle 1
Day 9
|
1 Participants
|
7 Participants
|
|
Number of Patients With ANC Nadir Per Day in Cycle 1
Days 10-15
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: across Cycle 1 (3 weeks)Population: FAS set = full analysis set
Time to absolute neutrophil count (ANC) recovery in Cycle 1 was defined as the time in days from ANC nadir until the patient's ANC had increased to ≥ 2 × 10\^9 cells/L. Only the evaluable patients with a depth of ANC in Cycle 1 and a later increase of ANC ≥ 2 × 10\^9 cells/L are given.
Outcome measures
| Measure |
LA-EP2006
n=154 Participants
During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
Neulasta®
n=154 Participants
During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
|---|---|---|
|
Time to ANC Recovery in Days in Cycle 1
|
1.58 days
Standard Deviation 1.053
|
1.72 days
Standard Deviation 1.100
|
SECONDARY outcome
Timeframe: across all cycles (18 weeks)Population: Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set
The number of patients with infections was recorded for each cycle and across all cycles. Infections were identified by the AE documentation page selecting all events coded with System Organ Class "Infections and Infestations".
Outcome measures
| Measure |
LA-EP2006
n=159 Participants
During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
Neulasta®
n=157 Participants
During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
|---|---|---|
|
Frequency of Infections by Cycle and Across All Cycles
Cycle 1
|
7 Participants
|
4 Participants
|
|
Frequency of Infections by Cycle and Across All Cycles
Cycle 2
|
6 Participants
|
5 Participants
|
|
Frequency of Infections by Cycle and Across All Cycles
Cycle 3
|
3 Participants
|
8 Participants
|
|
Frequency of Infections by Cycle and Across All Cycles
Cycle 4
|
2 Participants
|
3 Participants
|
|
Frequency of Infections by Cycle and Across All Cycles
Cycle 5
|
11 Participants
|
4 Participants
|
|
Frequency of Infections by Cycle and Across All Cycles
Cycle 6
|
5 Participants
|
3 Participants
|
|
Frequency of Infections by Cycle and Across All Cycles
Overall
|
22 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Study course (41 weeks)Population: FAS set = full analysis set
Number of patients with death due to infections
Outcome measures
| Measure |
LA-EP2006
n=159 Participants
During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
Neulasta®
n=157 Participants
During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
|---|---|---|
|
Mortality Due to Infection
Yes
|
0 Participants
|
2 Participants
|
|
Mortality Due to Infection
No
|
159 Participants
|
155 Participants
|
Adverse Events
LA-EP2006
Serious events: 16 serious events
Other events: 140 other events
Deaths: 4 deaths
Neulasta®
Serious events: 21 serious events
Other events: 128 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
LA-EP2006
n=159 participants at risk
During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
Neulasta®
n=157 participants at risk
During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.7%
9/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
7.6%
12/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
3/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
3.8%
6/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Blood and lymphatic system disorders
Anemia
|
0.63%
1/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
1.3%
2/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.64%
1/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.64%
1/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.64%
1/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Infections and infestations
Neutropenic sepsis
|
1.3%
2/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.00%
0/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Infections and infestations
Cellulitis
|
0.63%
1/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.00%
0/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Infections and infestations
Diverticulitis
|
0.63%
1/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.00%
0/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Infections and infestations
Gastroenteritis
|
0.63%
1/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.00%
0/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.64%
1/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.64%
1/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
General disorders
Pyrexia
|
0.63%
1/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.64%
1/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
General disorders
Asthenia
|
0.63%
1/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.00%
0/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
General disorders
Disease progression
|
0.00%
0/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.64%
1/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
General disorders
Fatigue
|
0.00%
0/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.64%
1/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.3%
2/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.00%
0/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Cardiac disorders
Cardiac arrest
|
0.63%
1/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.00%
0/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.64%
1/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Gastrointestinal disorders
Gastritis
|
0.63%
1/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.00%
0/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Gastrointestinal disorders
Nausea
|
0.63%
1/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.00%
0/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.64%
1/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Vascular disorders
Phlebitis
|
0.00%
0/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.64%
1/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Vascular disorders
Thrombophlebitis
|
0.63%
1/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.00%
0/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Vascular disorders
Venous thrombosis
|
0.63%
1/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.00%
0/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.63%
1/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.00%
0/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.63%
1/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.00%
0/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Nervous system disorders
Dizziness
|
0.63%
1/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.00%
0/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Psychiatric disorders
Delirium febrile
|
0.63%
1/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.00%
0/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
0.64%
1/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
Other adverse events
| Measure |
LA-EP2006
n=159 participants at risk
During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
Neulasta®
n=157 participants at risk
During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
15.7%
25/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
19.1%
30/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Vascular disorders
Vascular disorders
|
5.7%
9/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
6.4%
10/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Cardiac disorders
Cardiac disorders
|
0.63%
1/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
3.2%
5/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
0.63%
1/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
3.2%
5/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
51.6%
82/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
50.3%
79/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.8%
14/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
10.2%
16/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
General disorders
Asthenia
|
39.6%
63/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
35.7%
56/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
General disorders
Fatigue
|
11.3%
18/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
13.4%
21/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
General disorders
Pyrexia
|
5.7%
9/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
7.6%
12/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
General disorders
Pain
|
4.4%
7/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
6.4%
10/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
General disorders
Odema peripheral
|
6.3%
10/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
3.2%
5/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Gastrointestinal disorders
Nausea
|
40.3%
64/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
36.9%
58/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Gastrointestinal disorders
Vomitting
|
21.4%
34/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
20.4%
32/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Gastrointestinal disorders
Diarrhoe
|
14.5%
23/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
19.7%
31/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Gastrointestinal disorders
Stomatitis
|
5.0%
8/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
8.3%
13/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Gastrointestinal disorders
Constipation
|
6.3%
10/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
5.7%
9/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
8/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
4.5%
7/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Blood and lymphatic system disorders
Anemia
|
10.1%
16/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
10.8%
17/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.9%
11/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
7.6%
12/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.9%
11/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
6.4%
10/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.3%
10/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
8.3%
13/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
8/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
8.3%
13/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.4%
7/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
5.1%
8/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
6/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
3.8%
6/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.63%
1/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
3.2%
5/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Infections and infestations
Respiratory tract infection viral
|
1.9%
3/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
5.7%
9/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Infections and infestations
Respiratory tract infection
|
3.1%
5/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
1.3%
2/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.4%
7/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
10.2%
16/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.9%
3/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
5.1%
8/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Nervous system disorders
Headache
|
3.1%
5/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
5.7%
9/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
6/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
1.9%
3/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Investigations
Aspatate aminotransferase increased
|
3.8%
6/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
1.3%
2/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Investigations
Weight decreased
|
1.9%
3/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
3.2%
5/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.3%
2/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
3.2%
5/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
4/159 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
3.8%
6/157 • Patients were followed for a 6-month safety period from the last administration of pegfilgrastim.
If not otherwise specified, only treatment-emergent adverse event (TEAEs) (i.e. AEs with a date of onset on or after the date of the first administration of chemotherapy and not later than 30 days after the last dose of chemotherapy) and post-TEAEs (i.e. AEs with a date of onset after the time point of 30 days after the last chemotherapy administration) are reported. SAF set = safety analysis set was used
|
Additional Information
Strategic Planning, Biopharmaceutical Clinical Development
Sandoz
Phone: +49 (0) 8024 476 - 0
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place