NCT03252431 · ADVERSE EVENTS

Adverse events

Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy · Source last updated 2023-07-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).
Other-event reporting threshold: 5%

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.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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	12 / 197	70 / 197	1 / 197
Neulasta 6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles Neulasta: single dose pre-filled syringe	3 / 196	51 / 196	2 / 196

Group identifiers: EG000: F-627 · EG001: Neulasta

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
2
num At Risk
197
num Events
2
group Id
EG001
num Affected
0
num At Risk
196
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
197
num Events
1
group Id
EG001
num Affected
0
num At Risk
196
num Events
0
term
fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
197
num Events
1
group Id
EG001
num Affected
0
num At Risk
196
num Events
0
term
diabetic ketoacidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
197
num Events
1
group Id
EG001
num Affected
0
num At Risk
196
num Events
0
term
syncope
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
197
num Events
1
group Id
EG001
num Affected
0
num At Risk
196
num Events
0
term
acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
197
num Events
1
group Id
EG001
num Affected
0
num At Risk
196
num Events
0
term
pulmonary embolism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
197
num Events
1
group Id
EG001
num Affected
0
num At Risk
196
num Events
0
term
hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
197
num Events
1
group Id
EG001
num Affected
0
num At Risk
196
num Events
0
term
angioedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
197
num Events
1
group Id
EG001
num Affected
0
num At Risk
196
num Events
0
term
urticaria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
0
num At Risk
197
num Events
0
group Id
EG001
num Affected
1
num At Risk
196
num Events
1
term
anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
0
num At Risk
197
num Events
0
group Id
EG001
num Affected
1
num At Risk
196
num Events
1
term
neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
2
num At Risk
197
num Events
2
group Id
EG001
num Affected
1
num At Risk
196
num Events
1
term
pneumonia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
31
num At Risk
197
num Events
54
group Id
EG001
num Affected
23
num At Risk
196
num Events
44
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
12
num At Risk
197
num Events
16
group Id
EG001
num Affected
6
num At Risk
196
num Events
9
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
14
num At Risk
197
num Events
58
group Id
EG001
num Affected
10
num At Risk
196
num Events
39
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
13
num At Risk
197
num Events
26
group Id
EG001
num Affected
12
num At Risk
196
num Events
18
term
Asthenia

Complete source fields

description

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.

event Groups

deaths Num Affected
1
deaths Num At Risk
197
description
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
id
EG000
other Num Affected
70
other Num At Risk
197
serious Num Affected
12
serious Num At Risk
197
title
F-627
deaths Num Affected
2
deaths Num At Risk
196
description
6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles Neulasta: single dose pre-filled syringe
id
EG001
other Num Affected
51
other Num At Risk
196
serious Num Affected
3
serious Num At Risk
196
title
Neulasta

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
31
num At Risk
197
num Events
54
group Id
EG001
num Affected
23
num At Risk
196
num Events
44
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
12
num At Risk
197
num Events
16
group Id
EG001
num Affected
6
num At Risk
196
num Events
9
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
14
num At Risk
197
num Events
58
group Id
EG001
num Affected
10
num At Risk
196
num Events
39
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
13
num At Risk
197
num Events
26
group Id
EG001
num Affected
12
num At Risk
196
num Events
18
term
Asthenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
2
num At Risk
197
num Events
2
group Id
EG001
num Affected
0
num At Risk
196
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
197
num Events
1
group Id
EG001
num Affected
0
num At Risk
196
num Events
0
term
fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
197
num Events
1
group Id
EG001
num Affected
0
num At Risk
196
num Events
0
term
diabetic ketoacidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
197
num Events
1
group Id
EG001
num Affected
0
num At Risk
196
num Events
0
term
syncope
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
197
num Events
1
group Id
EG001
num Affected
0
num At Risk
196
num Events
0
term
acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
197
num Events
1
group Id
EG001
num Affected
0
num At Risk
196
num Events
0
term
pulmonary embolism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
197
num Events
1
group Id
EG001
num Affected
0
num At Risk
196
num Events
0
term
hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
197
num Events
1
group Id
EG001
num Affected
0
num At Risk
196
num Events
0
term
angioedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
197
num Events
1
group Id
EG001
num Affected
0
num At Risk
196
num Events
0
term
urticaria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
0
num At Risk
197
num Events
0
group Id
EG001
num Affected
1
num At Risk
196
num Events
1
term
anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
0
num At Risk
197
num Events
0
group Id
EG001
num Affected
1
num At Risk
196
num Events
1
term
neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
2
num At Risk
197
num Events
2
group Id
EG001
num Affected
1
num At Risk
196
num Events
1
term
pneumonia

time Frame

AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).

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