Trial Outcomes & Findings for Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy (NCT NCT03252431)
NCT ID: NCT03252431
Last Updated: 2023-07-03
Results Overview
Eligible subjects were randomized in a 1:1 ratio. Subjects were dosed with either the F 627 20 mg/dose PFS or Neulasta® 6 mg/dose as the study drug in each chemotherapy cycle. Subjects remained in their assigned treatment arm throughout the study. Subjects were dosed subcutaneously (SC) 24 to 28 hours after receiving TC chemotherapy (75 mg/m2 docetaxel + 600 mg/m2 cyclophosphamide) on Day 2 of each chemotherapy cycle that the subject underwent (up to 4 cycles). Grade 4 (severe) neutropenia was defined as ANC \<0.5 × 109/L within the first 12 days of chemotherapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
393 participants
Primary outcome timeframe
The first of 4, 21-day chemotherapy cycles (average 3 weeks)
Results posted on
2023-07-03
Participant Flow
Participant milestones
| Measure |
F-627
F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.
F-627: single dose pre-filled syringe
|
Neulasta
6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles
Neulasta: single dose pre-filled syringe
|
|---|---|---|
|
Overall Study
STARTED
|
197
|
196
|
|
Overall Study
COMPLETED
|
186
|
187
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
Baseline characteristics by cohort
| Measure |
F-627
n=197 Participants
F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.
F-627: single dose pre-filled syringe
|
Neulasta
n=196 Participants
6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles
Neulasta: single dose pre-filled syringe
|
Total
n=393 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 11.82 • n=5 Participants
|
53.4 years
STANDARD_DEVIATION 11.11 • n=7 Participants
|
52.4 years
STANDARD_DEVIATION 11.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
197 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
393 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
197 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
392 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
197 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
393 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
73 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
82 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Weight
|
75.84 kg
STANDARD_DEVIATION 16.884 • n=5 Participants
|
74.93 kg
STANDARD_DEVIATION 16.873 • n=7 Participants
|
75.39 kg
STANDARD_DEVIATION 16.863 • n=5 Participants
|
|
Height
|
162.6 cm
STANDARD_DEVIATION 6.27 • n=5 Participants
|
162.2 cm
STANDARD_DEVIATION 6.67 • n=7 Participants
|
162.4 cm
STANDARD_DEVIATION 6.47 • n=5 Participants
|
|
Basal Metabolic Index
|
28.72 kg/m2
STANDARD_DEVIATION 6.358 • n=5 Participants
|
28.51 kg/m2
STANDARD_DEVIATION 6.197 • n=7 Participants
|
28.62 kg/m2
STANDARD_DEVIATION 6.271 • n=5 Participants
|
PRIMARY outcome
Timeframe: The first of 4, 21-day chemotherapy cycles (average 3 weeks)Population: ITT (Intent-to-Treat) population
Eligible subjects were randomized in a 1:1 ratio. Subjects were dosed with either the F 627 20 mg/dose PFS or Neulasta® 6 mg/dose as the study drug in each chemotherapy cycle. Subjects remained in their assigned treatment arm throughout the study. Subjects were dosed subcutaneously (SC) 24 to 28 hours after receiving TC chemotherapy (75 mg/m2 docetaxel + 600 mg/m2 cyclophosphamide) on Day 2 of each chemotherapy cycle that the subject underwent (up to 4 cycles). Grade 4 (severe) neutropenia was defined as ANC \<0.5 × 109/L within the first 12 days of chemotherapy.
Outcome measures
| Measure |
F-627
n=197 Participants
F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.
F-627: single dose pre-filled syringe
|
Neulasta
n=196 Participants
6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles
Neulasta: single dose pre-filled syringe
|
|---|---|---|
|
Duration in Days of Grade 4 Neutropenia in Chemotherapy Cycle 1
|
0.2 days
Standard Deviation 0.51
|
0.2 days
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: across all 4 chemotherapy cycles (average 84 days)Population: ITT (Intent-to-Treat) population
The duration of use of IV antibiotics was defined as the number of days in which IV antibiotics were administered
Outcome measures
| Measure |
F-627
n=197 Participants
F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.
F-627: single dose pre-filled syringe
|
Neulasta
n=196 Participants
6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles
Neulasta: single dose pre-filled syringe
|
|---|---|---|
|
Duration in Days of Use of Intravenous Antibiotic
|
0.3 days
Standard Deviation 1.36
|
0.1 days
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: across all 4 chemotherapy cycles (average 84 days)Population: ITT (Intent-to-Treat) population
The duration in days of patients been hospitalized for febrile neutropenia (FN) or any infection. Febrile neutropenia is defined as a single oral temperature of ≥38.3°C (101°F) or a temperature of \>38.0°C (100.4°F) sustained for \>1 hour and ANC \<0.5 x 10\^9/L on the same day.
Outcome measures
| Measure |
F-627
n=197 Participants
F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.
F-627: single dose pre-filled syringe
|
Neulasta
n=196 Participants
6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles
Neulasta: single dose pre-filled syringe
|
|---|---|---|
|
Duration in Days of Hospitalization
|
0.1 days
Standard Deviation 0.78
|
0 days
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: The first of 4, 21-day chemotherapy cycles (average 3 weeks)Population: ITT (Intent-to-Treat) population
The number of participants with grade 4 neutropenia for chemotherapy cycle 1. Grade 4 (severe) neutropenia was defined as ANC \<0.5 × 109/L within the first 12 days of chemotherapy.
Outcome measures
| Measure |
F-627
n=197 Participants
F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.
F-627: single dose pre-filled syringe
|
Neulasta
n=196 Participants
6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles
Neulasta: single dose pre-filled syringe
|
|---|---|---|
|
The Number of Participants With Grade 4 Neutropenia for Chemotherapy Cycle 1
|
23 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: across all 4 chemotherapy cycles (average 84 days)Population: ITT (Intent-to-Treat) population
The number of participants with febrile neutropenia, considering all chemotherapy cycles.
Outcome measures
| Measure |
F-627
n=197 Participants
F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.
F-627: single dose pre-filled syringe
|
Neulasta
n=196 Participants
6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles
Neulasta: single dose pre-filled syringe
|
|---|---|---|
|
The Number of Participants With Febrile Neutropenia Considering All Chemotherapy Cycles.
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: across all 4 chemotherapy cycles (average 84 days)Population: ITT (Intent-to-Treat) population
The number of participants with use of IV antibiotics, considering all chemotherapy cycles.
Outcome measures
| Measure |
F-627
n=197 Participants
F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.
F-627: single dose pre-filled syringe
|
Neulasta
n=196 Participants
6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles
Neulasta: single dose pre-filled syringe
|
|---|---|---|
|
The Number of Participants With Use of IV Antibiotics Considering All Chemotherapy Cycles.
|
9 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: across all 4 chemotherapy cycles (average 84 days)Population: ITT (Intent-to-Treat) population
The number of participants in hospitalization for febrile neutropenia or any infection, .
Outcome measures
| Measure |
F-627
n=197 Participants
F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.
F-627: single dose pre-filled syringe
|
Neulasta
n=196 Participants
6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles
Neulasta: single dose pre-filled syringe
|
|---|---|---|
|
The Number of Participants in Hospitalization for Febrile Neutropenia or Any Infection Considering All Chemotherapy Cycles
|
1 Participants
|
1 Participants
|
Adverse Events
F-627
Serious events: 12 serious events
Other events: 70 other events
Deaths: 1 deaths
Neulasta
Serious events: 3 serious events
Other events: 51 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
F-627
n=197 participants at risk
F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.
F-627: single dose pre-filled syringe
|
Neulasta
n=196 participants at risk
6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles
Neulasta: single dose pre-filled syringe
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.0%
2/197 • Number of events 2 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
0.00%
0/196 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
|
General disorders
fatigue
|
0.51%
1/197 • Number of events 1 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
0.00%
0/196 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
|
Metabolism and nutrition disorders
diabetic ketoacidosis
|
0.51%
1/197 • Number of events 1 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
0.00%
0/196 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
|
Nervous system disorders
syncope
|
0.51%
1/197 • Number of events 1 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
0.00%
0/196 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
|
Renal and urinary disorders
acute kidney injury
|
0.51%
1/197 • Number of events 1 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
0.00%
0/196 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.51%
1/197 • Number of events 1 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
0.00%
0/196 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
|
Vascular disorders
hypertension
|
0.51%
1/197 • Number of events 1 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
0.00%
0/196 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
|
Skin and subcutaneous tissue disorders
angioedema
|
0.51%
1/197 • Number of events 1 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
0.00%
0/196 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
|
Skin and subcutaneous tissue disorders
urticaria
|
0.51%
1/197 • Number of events 1 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
0.00%
0/196 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/197 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
0.51%
1/196 • Number of events 1 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
|
Blood and lymphatic system disorders
neutropenia
|
0.00%
0/197 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
0.51%
1/196 • Number of events 1 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
1.0%
2/197 • Number of events 2 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
0.51%
1/196 • Number of events 1 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/197 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
0.51%
1/196 • Number of events 1 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/197 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
0.51%
1/196 • Number of events 1 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
Other adverse events
| Measure |
F-627
n=197 participants at risk
F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.
F-627: single dose pre-filled syringe
|
Neulasta
n=196 participants at risk
6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles
Neulasta: single dose pre-filled syringe
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
15.7%
31/197 • Number of events 54 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
11.7%
23/196 • Number of events 44 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
12/197 • Number of events 16 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
3.1%
6/196 • Number of events 9 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.1%
14/197 • Number of events 58 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
5.1%
10/196 • Number of events 39 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
|
Gastrointestinal disorders
Asthenia
|
6.6%
13/197 • Number of events 26 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
6.1%
12/196 • Number of events 18 • AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place