Trial Outcomes & Findings for Study to Compare the Efficacy and Safety of F-627 and GRAN® (NCT NCT04174599)

NCT ID: NCT04174599

Last Updated: 2025-04-20

Results Overview

Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 242 participants
• Primary outcome timeframe: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
• Results posted on: 2025-04-20

Participant Flow

Participant milestones

Measure	F-627 F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy F-627: Single dose pre-filled syringe	GRAN® Recombinant Human Granulocyte Colony Stimulating Factor (GRAN®) \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy GRAN®: Multi-dose pre-filled syringe
Overall Study STARTED	122	120
Overall Study COMPLETED	113	101
Overall Study NOT COMPLETED	9	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Compare the Efficacy and Safety of F-627 and GRAN®

Baseline characteristics by cohort

Measure	F-627 n=120 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=119 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	Total n=239 Participants Total of all reporting groups
Age, Continuous	49.1 years STANDARD_DEVIATION 9.32 • n=93 Participants	48.5 years STANDARD_DEVIATION 9.14 • n=4 Participants	48.8 years STANDARD_DEVIATION 9.21 • n=27 Participants
Sex: Female, Male Female	120 Participants n=93 Participants	119 Participants n=4 Participants	239 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	120 Participants n=93 Participants	119 Participants n=4 Participants	239 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	120 Participants n=93 Participants	119 Participants n=4 Participants	239 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment China	120 participants n=93 Participants	119 participants n=4 Participants	239 participants n=27 Participants
Height	157.97 m STANDARD_DEVIATION 5.061 • n=93 Participants	157.87 m STANDARD_DEVIATION 5.524 • n=4 Participants	157.92 m STANDARD_DEVIATION 5.286 • n=27 Participants
Weight	58.96 kg STANDARD_DEVIATION 8.945 • n=93 Participants	59.24 kg STANDARD_DEVIATION 8.487 • n=4 Participants	59.10 kg STANDARD_DEVIATION 8.703 • n=27 Participants
Body mass index (BMI)	23.609 kg/m^2 STANDARD_DEVIATION 3.278 • n=93 Participants	23.782 kg/m^2 STANDARD_DEVIATION 3.336 • n=4 Participants	23.695 kg/m^2 STANDARD_DEVIATION 3.301 • n=27 Participants
body surface area (BSA)	1.591 m^2 STANDARD_DEVIATION 0.123 • n=93 Participants	1.594 m^2 STANDARD_DEVIATION 0.116 • n=4 Participants	1.593 m^2 STANDARD_DEVIATION 0.119 • n=27 Participants

PRIMARY outcome

Timeframe: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 1

Grade 3 defined as ANC <1.0×10^9/L and Grade 4 defined as ANC<0.5×10^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of < 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant.

The mean value was calculated as the sum of the durations (days) of ANC < 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Outcome measures

Measure	F-627 n=120 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=119 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Duration of Grade 3 or 4 Neutropenia (ANC <1.0×10^9/L) in Cycle 1	0.68 days Standard Deviation 1.100	0.71 days Standard Deviation 0.967

SECONDARY outcome

Timeframe: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 1

Grade 3 defined as ANC <1.0×10^9/L and Grade 4 defined as ANC<0.5×10^9/L

Outcome measures

Measure	F-627 n=120 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=119 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 1	41 Participants	51 Participants

SECONDARY outcome

Timeframe: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 2

Grade 3 defined as ANC <1.0×10^9/L and Grade 4 defined as ANC<0.5×10^9/L

Outcome measures

Measure	F-627 n=117 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=107 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 2	7 Participants	7 Participants

SECONDARY outcome

Timeframe: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 3

Grade 3 defined as ANC <1.0×10^9/L and Grade 4 defined as ANC<0.5×10^9/L

Outcome measures

Measure	F-627 n=115 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=103 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 3	4 Participants	18 Participants

SECONDARY outcome

Timeframe: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 4

Grade 3 defined as ANC <1.0×10^9/L and Grade 4 defined as ANC<0.5×10^9/L

Outcome measures

Measure	F-627 n=114 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=101 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 4	10 Participants	10 Participants

SECONDARY outcome

Timeframe: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 2

Grade 3 defined as ANC <1.0×10^9/L and Grade 4 defined as ANC<0.5×10^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of < 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant.

The mean value was calculated as the sum of the durations (days) of ANC < 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Outcome measures

Measure	F-627 n=117 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=107 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Duration of Grade 3 or 4 Neutropenia in Cycle 2	0.1 days Standard Deviation 0.35	0.1 days Standard Deviation 0.25

SECONDARY outcome

Timeframe: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 3

Grade 3 defined as ANC <1.0×10^9/L and Grade 4 defined as ANC<0.5×10^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of < 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant.

The mean value was calculated as the sum of the durations (days) of ANC < 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Outcome measures

Measure	F-627 n=115 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=103 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Duration of Grade 3 or 4 Neutropenia in Cycle 3	0.0 days Standard Deviation 0.18	0.2 days Standard Deviation 0.54

SECONDARY outcome

Timeframe: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 4

Grade 3 defined as ANC <1.0×10^9/L and Grade 4 defined as ANC<0.5×10^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of < 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant.

The mean value was calculated as the sum of the durations (days) of ANC < 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Outcome measures

Measure	F-627 n=114 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=101 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Duration of Grade 3 or 4 Neutropenia in Cycle 4	0.1 days Standard Deviation 0.38	0.1 days Standard Deviation 0.41

SECONDARY outcome

Timeframe: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 1

Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L.

Outcome measures

Measure	F-627 n=120 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=119 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Number of Participants With Grade 4 Neutropenia in Cycle 1	17 Participants	19 Participants

SECONDARY outcome

Timeframe: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 2

Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L.

Outcome measures

Measure	F-627 n=117 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=107 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Number of Participants With Grade 4 Neutropenia in Cycle 2	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 3

Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L.

Outcome measures

Measure	F-627 n=115 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=103 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Number of Participants With Grade 4 Neutropenia in Cycle 3	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 4

Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L.

Outcome measures

Measure	F-627 n=114 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=101 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Number of Participants With Grade 4 Neutropenia in Cycle 4	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 1

Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of < 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant.

The mean value was calculated as the sum of the durations (days) of ANC < 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Outcome measures

Measure	F-627 n=120 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=119 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Duration of Grade 4 Neutropenia in Cycle 1	0.3 days Standard Deviation 0.69	0.2 days Standard Deviation 0.58

SECONDARY outcome

Timeframe: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 2

Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of < 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant.

The mean value was calculated as the sum of the durations (days) of ANC < 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Outcome measures

Measure	F-627 n=117 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=107 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Duration of Grade 4 Neutropenia in Cycle 2	0.0 days Standard Deviation 0.13	0.0 days Standard Deviation 0.10

SECONDARY outcome

Timeframe: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 3

Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of < 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant.

The mean value was calculated as the sum of the durations (days) of ANC < 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Outcome measures

Measure	F-627 n=115 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=103 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Duration of Grade 4 Neutropenia in Cycle 3	0.0 days Standard Deviation 0.00	0.1 days Standard Deviation 0.34

SECONDARY outcome

Timeframe: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 4

Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of < 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant.

The mean value was calculated as the sum of the durations (days) of ANC < 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Outcome measures

Measure	F-627 n=114 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=101 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Duration of Grade 4 Neutropenia in Cycle 4	0.0 days Standard Deviation 0.13	0.0 days Standard Deviation 0.20

SECONDARY outcome

Timeframe: Overall 4, 21-day chemotherapy cycles(average 12 weeks)

Population: All subjects who have completed cycle 1 at least.

Grade 3 defined as ANC <1.0×10^9/L and Grade 4 defined as ANC<0.5×10^9/L According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of < 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant.

The mean value was calculated as the sum of the durations (days) of ANC < 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Outcome measures

Measure	F-627 n=120 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=119 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Overall Duration of Grade 3 or 4 Neutropenia in 4 Cycles	0.9 days Standard Deviation 1.44	1.1 days Standard Deviation 1.43

SECONDARY outcome

Timeframe: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 1.

Grade 2 or greater neutropenia is defined as ANC < 1.5 × 10^9/L

Outcome measures

Measure	F-627 n=120 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=119 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 1	58 Participants	67 Participants

SECONDARY outcome

Timeframe: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 2.

Grade 2 or greater neutropenia is defined as ANC < 1.5 × 10^9/L

Outcome measures

Measure	F-627 n=117 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=107 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 2	16 Participants	14 Participants

SECONDARY outcome

Timeframe: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 3.

Grade 2 or greater neutropenia is defined as ANC < 1.5 × 10^9/L

Outcome measures

Measure	F-627 n=115 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=103 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 3	14 Participants	30 Participants

SECONDARY outcome

Timeframe: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 4.

Grade 2 or greater neutropenia is defined as ANC < 1.5 × 10^9/L

Outcome measures

Measure	F-627 n=114 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=101 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 4	20 Participants	26 Participants

SECONDARY outcome

Timeframe: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 1.

Grade 2 or greater neutropenia is defined as ANC < 1.5 × 10^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of < 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant.

The mean value was calculated as the sum of the durations (days) of ANC < 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Outcome measures

Measure	F-627 n=120 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=119 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 1	1.1 days Standard Deviation 1.30	1.0 days Standard Deviation 1.10

SECONDARY outcome

Timeframe: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 2

Grade 2 or greater neutropenia is defined as ANC < 1.5 × 10^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of < 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant.

The mean value was calculated as the sum of the durations (days) of ANC < 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Outcome measures

Measure	F-627 n=117 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=107 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 2	0.2 days Standard Deviation 0.50	0.2 days Standard Deviation 0.50

SECONDARY outcome

Timeframe: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 3.

Grade 2 or greater neutropenia is defined as ANC < 1.5 × 10^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of < 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant.

The mean value was calculated as the sum of the durations (days) of ANC < 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Outcome measures

Measure	F-627 n=115 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=103 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 3	0.1 days Standard Deviation 0.42	0.4 days Standard Deviation 0.67

SECONDARY outcome

Timeframe: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 4.

Grade 2 or greater neutropenia is defined as ANC < 1.5 × 10^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of < 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant.

The mean value was calculated as the sum of the durations (days) of ANC < 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Outcome measures

Measure	F-627 n=114 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=101 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 4	0.3 days Standard Deviation 0.68	0.3 days Standard Deviation 0.63

SECONDARY outcome

Timeframe: From day 3 to day 13 of cycle 1 (11 days)

Population: All subjects who have completed cycle 1

The minimum value of ANC measured from day 3 to day 13 of cycle 1

Outcome measures

Measure	F-627 n=120 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=119 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
The Absolute Neutrophil Counts (ANC) Nadir From Day 3 to Day 13 of Cycle 1	2.058 10^9 cell/L Standard Deviation 1.503	1.597 10^9 cell/L Standard Deviation 1.197

SECONDARY outcome

Timeframe: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 1

FN is defined as ANC < 1.0 × 10^9/L with fever (a single measurement of body temperature >38.3 °C or body temperature ≥ 38.0 °C for more than 1 hr).

Outcome measures

Measure	F-627 n=120 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=119 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Number of Participants With Febrile Neutropenia (FN) in Cycle 1	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 1

If the ANC nadir during the first 13 days of the cycle is < 2.0 × 10^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10^9/L, then the recovery time = 0 days.

Outcome measures

Measure	F-627 n=120 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=119 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 1	0.9 days Standard Deviation 1.01	1.0 days Standard Deviation 0.84

SECONDARY outcome

Timeframe: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 2

If the ANC nadir during the first 13 days of the cycle is < 2.0 × 10^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10^9/L, then the recovery time = 0 days.

Outcome measures

Measure	F-627 n=117 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=107 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 2	0.5 days Standard Deviation 1.10	0.7 days Standard Deviation 0.99

SECONDARY outcome

Timeframe: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 3

If the ANC nadir during the first 13 days of the cycle is < 2.0 × 10^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10^9/L, then the recovery time = 0 days.

Outcome measures

Measure	F-627 n=115 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=103 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 3	0.4 days Standard Deviation 0.87	0.9 days Standard Deviation 1.50

SECONDARY outcome

Timeframe: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)

Population: All subjects who have completed cycle 4

If the ANC nadir during the first 13 days of the cycle is < 2.0 × 10^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10^9/L, then the recovery time = 0 days.

Outcome measures

Measure	F-627 n=114 Participants F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=101 Participants GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 4	0.7 days Standard Deviation 1.14	1.2 days Standard Deviation 1.73

Adverse Events

F-627

Serious events: 6 serious events

Other events: 119 other events

Deaths: 0 deaths

GRAN®

Serious events: 8 serious events

Other events: 119 other events

Deaths: 0 deaths

Serious adverse events

Measure	F-627 n=120 participants at risk F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=119 participants at risk GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Investigations Neutrophil count decreased	2.5% 3/120 • Number of events 3 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	2.5% 3/119 • Number of events 3 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Investigations Platelet count decreased	2.5% 3/120 • Number of events 3 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	1.7% 2/119 • Number of events 2 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Investigations White blood cell count decreased	0.83% 1/120 • Number of events 1 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	0.00% 0/119 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Blood and lymphatic system disorders Febrile neutropenia	0.83% 1/120 • Number of events 1 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	1.7% 2/119 • Number of events 2 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/120 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	0.84% 1/119 • Number of events 1 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/120 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	0.84% 1/119 • Number of events 1 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Vascular disorders Jugular vein thrombosis	0.83% 1/120 • Number of events 1 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	0.00% 0/119 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.

Other adverse events

Measure	F-627 n=120 participants at risk F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy	GRAN® n=119 participants at risk GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
Gastrointestinal disorders Nausea	86.7% 104/120 • Number of events 104 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	85.7% 102/119 • Number of events 102 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Gastrointestinal disorders Vomiting	63.3% 76/120 • Number of events 76 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	74.8% 89/119 • Number of events 89 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Gastrointestinal disorders Constipation	14.2% 17/120 • Number of events 17 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	14.3% 17/119 • Number of events 17 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Gastrointestinal disorders Abdominal distension	11.7% 14/120 • Number of events 14 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	6.7% 8/119 • Number of events 8 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Gastrointestinal disorders Abdominal pain upper	5.8% 7/120 • Number of events 7 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	10.1% 12/119 • Number of events 12 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Gastrointestinal disorders Diarrhoea	8.3% 10/120 • Number of events 10 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	7.6% 9/119 • Number of events 9 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Gastrointestinal disorders Dry mouth	5.8% 7/120 • Number of events 7 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	6.7% 8/119 • Number of events 8 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Gastrointestinal disorders Stomatitis	3.3% 4/120 • Number of events 4 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	5.0% 6/119 • Number of events 6 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Investigations White blood cell count decreased	65.8% 79/120 • Number of events 79 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	83.2% 99/119 • Number of events 99 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Investigations Neutrophil count decreased	59.2% 71/120 • Number of events 71 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	83.2% 99/119 • Number of events 99 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Investigations Platelet count decreased	46.7% 56/120 • Number of events 56 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	33.6% 40/119 • Number of events 40 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Investigations Alanine aminotransferase increased	30.0% 36/120 • Number of events 36 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	16.0% 19/119 • Number of events 19 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Investigations Aspartate aminotransferase increased	25.0% 30/120 • Number of events 30 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	11.8% 14/119 • Number of events 14 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Investigations Weight decreased	5.0% 6/120 • Number of events 6 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	5.9% 7/119 • Number of events 7 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Investigations Weight increased	7.5% 9/120 • Number of events 9 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	3.4% 4/119 • Number of events 4 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Skin and subcutaneous tissue disorders Alopecia	77.5% 93/120 • Number of events 93 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	69.7% 83/119 • Number of events 83 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Blood and lymphatic system disorders Anaemia	67.5% 81/120 • Number of events 81 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	66.4% 79/119 • Number of events 79 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Musculoskeletal and connective tissue disorders Bone pain	25.0% 30/120 • Number of events 30 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	33.6% 40/119 • Number of events 40 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Musculoskeletal and connective tissue disorders Back pain	15.8% 19/120 • Number of events 19 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	23.5% 28/119 • Number of events 28 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Musculoskeletal and connective tissue disorders Myalgia	4.2% 5/120 • Number of events 5 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	6.7% 8/119 • Number of events 8 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
General disorders Asthenia	35.0% 42/120 • Number of events 42 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	29.4% 35/119 • Number of events 35 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
General disorders Chest discomfort	6.7% 8/120 • Number of events 8 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	5.9% 7/119 • Number of events 7 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Metabolism and nutrition disorders Decreased appetite	24.2% 29/120 • Number of events 29 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	25.2% 30/119 • Number of events 30 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Nervous system disorders Dizziness	6.7% 8/120 • Number of events 8 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	11.8% 14/119 • Number of events 14 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Nervous system disorders Headache	5.8% 7/120 • Number of events 7 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	12.6% 15/119 • Number of events 15 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Nervous system disorders Somnolence	7.5% 9/120 • Number of events 9 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	3.4% 4/119 • Number of events 4 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Nervous system disorders Poor quality sleep	0.83% 1/120 • Number of events 1 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	5.9% 7/119 • Number of events 7 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Ear and labyrinth disorders Vertigo	22.5% 27/120 • Number of events 27 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	17.6% 21/119 • Number of events 21 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Infections and infestations Upper respiratory tract infection	11.7% 14/120 • Number of events 14 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	13.4% 16/119 • Number of events 16 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Psychiatric disorders Insomnia	11.7% 14/120 • Number of events 14 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	13.4% 16/119 • Number of events 16 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Respiratory, thoracic and mediastinal disorders Cough	8.3% 10/120 • Number of events 10 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	5.9% 7/119 • Number of events 7 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
Cardiac disorders Palpitations	5.8% 7/120 • Number of events 7 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.	0.84% 1/119 • Number of events 1 • Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.

Additional Information

Catrina Wang

Evivebiotech

Phone: 021-61760866

Email: catrina.wang@evivebiotech.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place