Trial Outcomes & Findings for Study of IL-22 IgG2-Fc (F-652) for Subjects With Grade II-IV Lower GI aGVHD (NCT NCT02406651)
NCT ID: NCT02406651
Last Updated: 2021-07-22
Results Overview
The number of participants with lower Gastrointestinal Acute Graft-Versus-Host-Disease treatment response rate on Day 28.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
28 days after first treatment of F-652
Results posted on
2021-07-22
Participant Flow
Participant milestones
| Measure |
F-652 and Systemic Coritcosteroids
Subjects was dosed once a week for four weeks with Recombinant Human Interleukin-22 IgG2-Fc (F-652). Dosing was concurrent with systemic corticosteroids.
Recombinant Human Interleukin-22 IgG2-Fc (F-652): IV infusion of reconstitution lyophilized F-652.
Systemic Corticosteroids: Prednisone (or equivalent) was at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD, as per the standard of care. Prednisone (or equivalent) was given at a dose of 2 mg/kg/day and tapered as needed.
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|---|---|
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Overall Study
STARTED
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30
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Overall Study
COMPLETED
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27
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|
Overall Study
NOT COMPLETED
|
3
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Reasons for withdrawal
| Measure |
F-652 and Systemic Coritcosteroids
Subjects was dosed once a week for four weeks with Recombinant Human Interleukin-22 IgG2-Fc (F-652). Dosing was concurrent with systemic corticosteroids.
Recombinant Human Interleukin-22 IgG2-Fc (F-652): IV infusion of reconstitution lyophilized F-652.
Systemic Corticosteroids: Prednisone (or equivalent) was at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD, as per the standard of care. Prednisone (or equivalent) was given at a dose of 2 mg/kg/day and tapered as needed.
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|---|---|
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Overall Study
30 subjects dosed based on initial screening. 3 subjects were removed because they screened fail.
|
3
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Baseline Characteristics
Per CSR, only 29 subjects were analyzed. One subject, site inadvertently did not collect the height.
Baseline characteristics by cohort
| Measure |
F-652 and Systemic Coritcosteroids
n=30 Participants
Subjects will be dosed once a week for four weeks with Recombinant Human Interleukin-22 IgG2-Fc (F-652). Dosing will be concurrent with systemic corticosteroids.
Recombinant Human Interleukin-22 IgG2-Fc (F-652): IV infusion of reconstitution lyophilized F-652.
Systemic Corticosteroids: Prednisone (or equivalent) was at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD, as per the standard of care. Prednisone (or equivalent) will be given at a dose of 2 mg/kg/day and tapered as needed.
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|---|---|
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Age, Continuous
|
51.1 years
STANDARD_DEVIATION 15.88 • n=30 Participants
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|
Sex: Female, Male
Female
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14 Participants
n=30 Participants
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Sex: Female, Male
Male
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16 Participants
n=30 Participants
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|
Race/Ethnicity, Customized
White
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24 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Black or African American
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3 Participants
n=30 Participants
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|
Race/Ethnicity, Customized
Asian
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2 Participants
n=30 Participants
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|
Race/Ethnicity, Customized
Other
|
1 Participants
n=30 Participants
|
|
Region of Enrollment
United States
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30 participants
n=30 Participants
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|
Weight
|
74.47 kg
STANDARD_DEVIATION 20.457 • n=30 Participants
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Height
|
167.73 cm
STANDARD_DEVIATION 10.753 • n=29 Participants • Per CSR, only 29 subjects were analyzed. One subject, site inadvertently did not collect the height.
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PRIMARY outcome
Timeframe: 28 days after first treatment of F-652Population: 30 participants were dosed based on initial screening. Then 3 of the 30 participants were removed after receiving one dose because they failed inclusion/exclusion criteria leaving 27 participants to continue in the study. All participants were exposed to study drug.
The number of participants with lower Gastrointestinal Acute Graft-Versus-Host-Disease treatment response rate on Day 28.
Outcome measures
| Measure |
F-652 and Systemic Coritcosteroids
n=27 Participants
Subjects were dosed once a week for four weeks with Recombinant Human Interleukin-22 IgG2-Fc (F-652). Dosing were concurrent with systemic corticosteroids.
Recombinant Human Interleukin-22 IgG2-Fc (F-652): IV infusion of reconstitution lyophilized F-652.
Systemic Corticosteroids: Prednisone (or equivalent) was at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD, as per the standard of care. Prednisone (or equivalent) were given at a dose of 2 mg/kg/day and tapered as needed.
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|---|---|
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The Number of Participants With Lower Gastrointestinal Acute Graft-Versus-Host-Disease Treatment Response Rate on Day 28
Treatment Response
|
19 Participants
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|
The Number of Participants With Lower Gastrointestinal Acute Graft-Versus-Host-Disease Treatment Response Rate on Day 28
No Treatment Response
|
8 Participants
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SECONDARY outcome
Timeframe: Measured at day 14 and 56 after initial dosing of F-652Population: 30 participants were dosed based on initial screening. Then 3 of the 30 participants were removed after receiving one dose because they failed inclusion/exclusion criteria leaving 27 participants to continue in the study. All were exposed to the study drug, so they were included in the safety population.
The number of participants with Lower GI aGVHD treatment response at days 14 and 56 categorized by complete response (CR), very good partial response (VGPR), partial response (PR), no response (NR)/stable, and progression
Outcome measures
| Measure |
F-652 and Systemic Coritcosteroids
n=27 Participants
Subjects were dosed once a week for four weeks with Recombinant Human Interleukin-22 IgG2-Fc (F-652). Dosing were concurrent with systemic corticosteroids.
Recombinant Human Interleukin-22 IgG2-Fc (F-652): IV infusion of reconstitution lyophilized F-652.
Systemic Corticosteroids: Prednisone (or equivalent) was at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD, as per the standard of care. Prednisone (or equivalent) were given at a dose of 2 mg/kg/day and tapered as needed.
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|---|---|
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The Number of Participants With Lower GI aGVHD Treatment Response at Days 14 and 56.
Day 14 CR Treatment Response
|
14 Participants
|
|
The Number of Participants With Lower GI aGVHD Treatment Response at Days 14 and 56.
Day 14 VGPR Treatment Response
|
1 Participants
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|
The Number of Participants With Lower GI aGVHD Treatment Response at Days 14 and 56.
Day 14 PR Treatment Response
|
4 Participants
|
|
The Number of Participants With Lower GI aGVHD Treatment Response at Days 14 and 56.
Day 14 No Treatment Response/Stable
|
2 Participants
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|
The Number of Participants With Lower GI aGVHD Treatment Response at Days 14 and 56.
Day 14 No Treatment Response/Progression
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0 Participants
|
|
The Number of Participants With Lower GI aGVHD Treatment Response at Days 14 and 56.
Day 56 CR Treatment Response
|
12 Participants
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|
The Number of Participants With Lower GI aGVHD Treatment Response at Days 14 and 56.
Day 56 VGPR Treatment Response
|
2 Participants
|
|
The Number of Participants With Lower GI aGVHD Treatment Response at Days 14 and 56.
Day 56 PR Treatment Response
|
0 Participants
|
|
The Number of Participants With Lower GI aGVHD Treatment Response at Days 14 and 56.
Day 56 No Treatment Response/Stable
|
1 Participants
|
|
The Number of Participants With Lower GI aGVHD Treatment Response at Days 14 and 56.
Day 56 No Treatment Response/Progression
|
2 Participants
|
SECONDARY outcome
Timeframe: Measured at day 14, 28 and 56 after initial dosing of F-652Population: 30 participants were dosed based on initial screening. Then 3 of the 30 participants were removed after receiving one dose because they failed inclusion/exclusion criteria leaving 27 participants to continue with the study. All participants were exposed to the study drug, so they were included in the safety population.
The number of participants with overall aGVHD treatment response at Days 14, 28, and 56 categorized by complete response (CR), partial response (PR), no response (NR), and progression.
Outcome measures
| Measure |
F-652 and Systemic Coritcosteroids
n=27 Participants
Subjects were dosed once a week for four weeks with Recombinant Human Interleukin-22 IgG2-Fc (F-652). Dosing were concurrent with systemic corticosteroids.
Recombinant Human Interleukin-22 IgG2-Fc (F-652): IV infusion of reconstitution lyophilized F-652.
Systemic Corticosteroids: Prednisone (or equivalent) was at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD, as per the standard of care. Prednisone (or equivalent) were given at a dose of 2 mg/kg/day and tapered as needed.
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|---|---|
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The Number of Participants With Overall aGVHD Treatment Response at Days 14, 28, and 56.
Day 28 PR Treatment Response
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2 Participants
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The Number of Participants With Overall aGVHD Treatment Response at Days 14, 28, and 56.
Day 28 Mixed Treatment Response
|
0 Participants
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|
The Number of Participants With Overall aGVHD Treatment Response at Days 14, 28, and 56.
Day 56 CR Treatment Response
|
12 Participants
|
|
The Number of Participants With Overall aGVHD Treatment Response at Days 14, 28, and 56.
Day 14 CR Treatment Response
|
14 Participants
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The Number of Participants With Overall aGVHD Treatment Response at Days 14, 28, and 56.
Day 14 VGPR Treatment Response
|
1 Participants
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The Number of Participants With Overall aGVHD Treatment Response at Days 14, 28, and 56.
Day 14 PR Treatment Response
|
4 Participants
|
|
The Number of Participants With Overall aGVHD Treatment Response at Days 14, 28, and 56.
Day 14 Mixed Treatment Response
|
1 Participants
|
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The Number of Participants With Overall aGVHD Treatment Response at Days 14, 28, and 56.
Day 14 No Treatment Response/Stable
|
1 Participants
|
|
The Number of Participants With Overall aGVHD Treatment Response at Days 14, 28, and 56.
Day 14 No Treatment Response/Progression
|
0 Participants
|
|
The Number of Participants With Overall aGVHD Treatment Response at Days 14, 28, and 56.
Day 28 CR Treatment Response
|
13 Participants
|
|
The Number of Participants With Overall aGVHD Treatment Response at Days 14, 28, and 56.
Day 28 VGPR Treatment Response
|
4 Participants
|
|
The Number of Participants With Overall aGVHD Treatment Response at Days 14, 28, and 56.
Day 28 No Treatment Response/Stable
|
5 Participants
|
|
The Number of Participants With Overall aGVHD Treatment Response at Days 14, 28, and 56.
Day 28 No Treatment Response/Progression
|
3 Participants
|
|
The Number of Participants With Overall aGVHD Treatment Response at Days 14, 28, and 56.
Day 56 VGPR Treatment Response
|
2 Participants
|
|
The Number of Participants With Overall aGVHD Treatment Response at Days 14, 28, and 56.
Day 56 PR Treatment Response
|
0 Participants
|
|
The Number of Participants With Overall aGVHD Treatment Response at Days 14, 28, and 56.
Day 56 Mixed Response Treatment Response
|
1 Participants
|
|
The Number of Participants With Overall aGVHD Treatment Response at Days 14, 28, and 56.
Day 56 No Treatment Response/Stable
|
1 Participants
|
|
The Number of Participants With Overall aGVHD Treatment Response at Days 14, 28, and 56.
Day 56 No Treatment Response/Progression
|
1 Participants
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SECONDARY outcome
Timeframe: Measured at Day 180 and 1 year after initial dosing of F-652.Population: 30 participants were dosed based on initial screening. Then 3 of the 30 participants were removed after receiving one dose because they failed inclusion/exclusion criteria leaving 27 participants to continue with the study. All were exposed to the study drug, so they were included in the safety population. The number of participants analyzed on Day 180 and 1 year post initial dosing of study drug is 11 and 10 respectively, because these participants were not lost to follow ups.
The number of participants with discontinuation of immunosuppressive medication at day 180 and one year post initial dose.
Outcome measures
| Measure |
F-652 and Systemic Coritcosteroids
n=27 Participants
Subjects were dosed once a week for four weeks with Recombinant Human Interleukin-22 IgG2-Fc (F-652). Dosing were concurrent with systemic corticosteroids.
Recombinant Human Interleukin-22 IgG2-Fc (F-652): IV infusion of reconstitution lyophilized F-652.
Systemic Corticosteroids: Prednisone (or equivalent) was at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD, as per the standard of care. Prednisone (or equivalent) were given at a dose of 2 mg/kg/day and tapered as needed.
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|---|---|
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The Number of Participants With Discontinuation of Immunosuppressive Medication at Day 180 and 1 Year Post Initial Dosing of F-652.
Day 180 discontinuation of immunosuppressive medication
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11 Participants
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The Number of Participants With Discontinuation of Immunosuppressive Medication at Day 180 and 1 Year Post Initial Dosing of F-652.
1 year discontinuation of immunosuppressive medication
|
10 Participants
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SECONDARY outcome
Timeframe: Measured 1 year after first infusion.Population: 30 participants were dosed based on initial screening. Then 3 of the 30 participants were removed after receiving one dose because they failed inclusion/exclusion criteria leaving 27 participants to continue with the study. All were exposed to the study drug, so they were included in the safety population. On the data table below, there were 3 subjects with an event were not analyzed. 24 subjects were censored for analysis.
The number of participants with overall survival at 1 year after first infusion of F-652.
Outcome measures
| Measure |
F-652 and Systemic Coritcosteroids
n=27 Participants
Subjects were dosed once a week for four weeks with Recombinant Human Interleukin-22 IgG2-Fc (F-652). Dosing were concurrent with systemic corticosteroids.
Recombinant Human Interleukin-22 IgG2-Fc (F-652): IV infusion of reconstitution lyophilized F-652.
Systemic Corticosteroids: Prednisone (or equivalent) was at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD, as per the standard of care. Prednisone (or equivalent) were given at a dose of 2 mg/kg/day and tapered as needed.
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|---|---|
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The Number of Participants With Overall Survival at 1 Year After First Infusion of F-652.
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24 Participants
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Adverse Events
F-652 and Systemic Coritcosteroids
Serious events: 10 serious events
Other events: 26 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
F-652 and Systemic Coritcosteroids
n=30 participants at risk
Subjects were dosed once a week for four weeks with Recombinant Human Interleukin-22 IgG2-Fc (F-652). Dosing will be concurrent with systemic corticosteroids.
Recombinant Human Interleukin-22 IgG2-Fc (F-652): IV infusion of reconstitution lyophilized F-652.
Systemic Corticosteroids: Prednisone (or equivalent) was given at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD, as per the standard of care. Prednisone (or equivalent) were given at a dose of 2 mg/kg/day and tapered as needed.
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|---|---|
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Gastrointestinal disorders
enterocolitis
|
3.3%
1/30 • Number of events 1 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
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General disorders
pyrexia
|
3.3%
1/30 • Number of events 1 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
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Infections and infestations
sepsis
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6.7%
2/30 • Number of events 3 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
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|
Injury, poisoning and procedural complications
devise related infection
|
6.7%
2/30 • Number of events 2 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
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|
Infections and infestations
klebsiella infection
|
6.7%
2/30 • Number of events 2 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
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|
Infections and infestations
streptococcal pneumonia
|
3.3%
1/30 • Number of events 1 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
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|
Infections and infestations
sinusitis
|
3.3%
1/30 • Number of events 1 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
muscular weakness
|
3.3%
1/30 • Number of events 1 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
3.3%
1/30 • Number of events 1 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
dypsnea
|
3.3%
1/30 • Number of events 1 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
Other adverse events
| Measure |
F-652 and Systemic Coritcosteroids
n=30 participants at risk
Subjects were dosed once a week for four weeks with Recombinant Human Interleukin-22 IgG2-Fc (F-652). Dosing will be concurrent with systemic corticosteroids.
Recombinant Human Interleukin-22 IgG2-Fc (F-652): IV infusion of reconstitution lyophilized F-652.
Systemic Corticosteroids: Prednisone (or equivalent) was given at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD, as per the standard of care. Prednisone (or equivalent) were given at a dose of 2 mg/kg/day and tapered as needed.
|
|---|---|
|
Blood and lymphatic system disorders
hypokalemia
|
50.0%
15/30 • Number of events 18 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
hyperglycemia
|
36.7%
11/30 • Number of events 11 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
hypomagnesemia
|
33.3%
10/30 • Number of events 11 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
hypophosphatemia
|
33.3%
10/30 • Number of events 11 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
hypoalbuminemia
|
33.3%
10/30 • Number of events 10 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
hyponatremia
|
30.0%
9/30 • Number of events 9 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
hypocalcemia
|
26.7%
8/30 • Number of events 8 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
hyperkalemia
|
20.0%
6/30 • Number of events 7 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
hypoglycemia
|
20.0%
6/30 • Number of events 7 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
hypermagnesemia
|
16.7%
5/30 • Number of events 5 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
hypertriglyceridemia
|
16.7%
5/30 • Number of events 5 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
platelet count decreased
|
43.3%
13/30 • Number of events 13 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
lymphocyte count decreased
|
36.7%
11/30 • Number of events 11 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
blood alkaline phosphatase increased
|
33.3%
10/30 • Number of events 10 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
white blood cell count decreased
|
30.0%
9/30 • Number of events 10 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
alanine aminotransferase increased
|
26.7%
8/30 • Number of events 8 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
blood bilirubin increased
|
26.7%
8/30 • Number of events 8 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
neutrophil count decreased
|
20.0%
6/30 • Number of events 7 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
aspartate aminotransferase increased
|
20.0%
6/30 • Number of events 6 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
international normalized ratio increased
|
16.7%
5/30 • Number of events 5 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
General disorders
fatigue
|
16.7%
5/30 • Number of events 7 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
General disorders
peripheral edema
|
16.7%
5/30 • Number of events 5 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Gastrointestinal disorders
dry mouth
|
20.0%
6/30 • Number of events 6 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Gastrointestinal disorders
vomiting
|
16.7%
5/30 • Number of events 6 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
23.3%
7/30 • Number of events 7 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Skin and subcutaneous tissue disorders
pruritus
|
16.7%
5/30 • Number of events 5 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
16.7%
5/30 • Number of events 5 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Blood and lymphatic system disorders
anemia
|
40.0%
12/30 • Number of events 16 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Psychiatric disorders
insomnia
|
23.3%
7/30 • Number of events 8 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
muscular weakness
|
30.0%
9/30 • Number of events 10 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
|
Vascular disorders
hypertension
|
20.0%
6/30 • Number of events 8 • AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place