Trial Outcomes & Findings for Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302) (NCT NCT00224874)
NCT ID: NCT00224874
Last Updated: 2021-11-01
Results Overview
Complete response at day 28 after randomization. CR was defined as resolution of all signs and symptoms of Graft-Versus-Host Disease (GVHD) in all evaluable organs in comparison to Day 1 scoring.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
180 participants
Primary outcome timeframe
Measured at Day 28
Results posted on
2021-11-01
Participant Flow
Clinic patients were recruited from August 2005 through March 2008.
Participant milestones
| Measure |
Etanercept
Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
|
Mycophenolate Mofetil
Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
|
Denileukin Diftitox
Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
|
Pentostatin
Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
46
|
45
|
47
|
42
|
|
Overall Study
COMPLETED
|
46
|
45
|
46
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Etanercept
Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
|
Mycophenolate Mofetil
Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
|
Denileukin Diftitox
Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
|
Pentostatin
Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302)
Baseline characteristics by cohort
| Measure |
Etanercept
n=46 Participants
Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
|
Mycophenolate Mofetil
n=45 Participants
Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
|
Denileukin Diftitox
n=47 Participants
Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
|
Pentostatin
n=42 Participants
Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
42 years
n=7 Participants
|
51 years
n=5 Participants
|
53 years
n=4 Participants
|
50 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
|
Primary Disease
Acute Myeloid Leukemia (AML) / MDS
|
24 participants
n=5 Participants
|
21 participants
n=7 Participants
|
24 participants
n=5 Participants
|
20 participants
n=4 Participants
|
89 participants
n=21 Participants
|
|
Primary Disease
Acute Lymphoblastic Leukemia (ALL)
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
4 participants
n=5 Participants
|
7 participants
n=4 Participants
|
26 participants
n=21 Participants
|
|
Primary Disease
Chronic Myeloid Leukemia (CML)
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Primary Disease
Lymphoma
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
6 participants
n=4 Participants
|
25 participants
n=21 Participants
|
|
Primary Disease
Other
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
9 participants
n=4 Participants
|
35 participants
n=21 Participants
|
|
Conditioning Regimen
Myeloablative
|
29 participants
n=5 Participants
|
37 participants
n=7 Participants
|
25 participants
n=5 Participants
|
26 participants
n=4 Participants
|
117 participants
n=21 Participants
|
|
Conditioning Regimen
Non-myeloablative
|
17 participants
n=5 Participants
|
8 participants
n=7 Participants
|
21 participants
n=5 Participants
|
15 participants
n=4 Participants
|
61 participants
n=21 Participants
|
|
Conditioning Regimen
Unknown
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Donor Status
Related
|
21 participants
n=5 Participants
|
24 participants
n=7 Participants
|
21 participants
n=5 Participants
|
17 participants
n=4 Participants
|
83 participants
n=21 Participants
|
|
Donor Status
Unrelated
|
24 participants
n=5 Participants
|
21 participants
n=7 Participants
|
25 participants
n=5 Participants
|
24 participants
n=4 Participants
|
94 participants
n=21 Participants
|
|
Donor Status
Unknown
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Stem Cell Type
Bone Marrow
|
5 participants
n=5 Participants
|
13 participants
n=7 Participants
|
15 participants
n=5 Participants
|
9 participants
n=4 Participants
|
42 participants
n=21 Participants
|
|
Stem Cell Type
Peripheral Blood
|
36 participants
n=5 Participants
|
29 participants
n=7 Participants
|
19 participants
n=5 Participants
|
27 participants
n=4 Participants
|
111 participants
n=21 Participants
|
|
Stem Cell Type
Umbilical Cord Blood
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
12 participants
n=5 Participants
|
5 participants
n=4 Participants
|
25 participants
n=21 Participants
|
|
Stem Cell Type
Unknown
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
MMF Prophylaxis
Yes
|
14 participants
n=5 Participants
|
0 participants
n=7 Participants
|
16 participants
n=5 Participants
|
14 participants
n=4 Participants
|
44 participants
n=21 Participants
|
|
MMF Prophylaxis
No
|
32 participants
n=5 Participants
|
45 participants
n=7 Participants
|
31 participants
n=5 Participants
|
28 participants
n=4 Participants
|
136 participants
n=21 Participants
|
|
Enrollment Acute GVHD
Grade 0
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Enrollment Acute GVHD
Grade I
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
4 participants
n=4 Participants
|
23 participants
n=21 Participants
|
|
Enrollment Acute GVHD
Grade II
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
23 participants
n=5 Participants
|
26 participants
n=4 Participants
|
99 participants
n=21 Participants
|
|
Enrollment Acute GVHD
Grade III
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
15 participants
n=5 Participants
|
11 participants
n=4 Participants
|
54 participants
n=21 Participants
|
|
Enrollment Acute GVHD
Grade IV
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Organ Involvement at Randomization
Skin
|
36 participants
n=5 Participants
|
35 participants
n=7 Participants
|
35 participants
n=5 Participants
|
34 participants
n=4 Participants
|
140 participants
n=21 Participants
|
|
Organ Involvement at Randomization
GI tract, lower
|
12 participants
n=5 Participants
|
18 participants
n=7 Participants
|
14 participants
n=5 Participants
|
17 participants
n=4 Participants
|
61 participants
n=21 Participants
|
|
Organ Involvement at Randomization
GI tract, upper
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
14 participants
n=5 Participants
|
13 participants
n=4 Participants
|
49 participants
n=21 Participants
|
|
Organ Involvement at Randomization
Liver
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
5 participants
n=4 Participants
|
25 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured at Day 28Population: All patients randomized were included in the analysis on an intent-to-treat basis
Complete response at day 28 after randomization. CR was defined as resolution of all signs and symptoms of Graft-Versus-Host Disease (GVHD) in all evaluable organs in comparison to Day 1 scoring.
Outcome measures
| Measure |
Etanercept
n=46 Participants
Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
|
Mycophenolate Mofetil
n=45 Participants
Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
|
Denileukin Diftitox
n=47 Participants
Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
|
Pentostatin
n=42 Participants
Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
|
|---|---|---|---|---|
|
Number of Complete Response (CR) at Day 28 of Therapy
|
12 participants
|
27 participants
|
25 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Measured at Day 28Population: All patients randomized were included in the analysis on an intent-to-treat basis
Partial response, mixed response, and progression at Day 28 after randomization. Partial response was defined as improvement in one or more organs involved with Graft-Versus-Host Disease (GVHD) symptoms without progression in others. Mixed response was defined as improvement in one or more organs with deterioration in another organ manifesting symptoms of GVHD or development of symptoms of GVHD in a new organ. Progression was defined as deterioration in at least one organ without any improvement in others.
Outcome measures
| Measure |
Etanercept
n=46 Participants
Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
|
Mycophenolate Mofetil
n=45 Participants
Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
|
Denileukin Diftitox
n=47 Participants
Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
|
Pentostatin
n=42 Participants
Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
|
|---|---|---|---|---|
|
Number of Partial Response (PR), Mixed Response (MR), and Progression
Partial Response
|
10 participants
|
8 participants
|
3 participants
|
10 participants
|
|
Number of Partial Response (PR), Mixed Response (MR), and Progression
Mixed Response
|
3 participants
|
4 participants
|
0 participants
|
2 participants
|
|
Number of Partial Response (PR), Mixed Response (MR), and Progression
Progression
|
7 participants
|
1 participants
|
3 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Measured at Day 56Outcome measures
| Measure |
Etanercept
n=46 Participants
Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
|
Mycophenolate Mofetil
n=45 Participants
Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
|
Denileukin Diftitox
n=47 Participants
Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
|
Pentostatin
n=42 Participants
Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
|
|---|---|---|---|---|
|
Proportion of Treatment Failure
|
24 percentage of participants
Interval 12.0 to 36.0
|
9 percentage of participants
Interval 6.0 to 17.0
|
26 percentage of participants
Interval 13.0 to 38.0
|
29 percentage of participants
Interval 15.0 to 42.0
|
SECONDARY outcome
Timeframe: Measured at Day 90Population: All patients randomized were included in the analysis on an intent-to-treat basis
Flares were defined as any increase in symptoms of or therapy for acute GVHD after an initial response (i.e., progression from an earlier CR or PR).
Outcome measures
| Measure |
Etanercept
n=46 Participants
Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
|
Mycophenolate Mofetil
n=45 Participants
Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
|
Denileukin Diftitox
n=47 Participants
Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
|
Pentostatin
n=42 Participants
Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
|
|---|---|---|---|---|
|
Number of Patients With Acute Graft-versus-host Disease (GVHD) Flares at Day 90
|
16 participants
Interval 0.21 to 0.49
|
12 participants
Interval 0.14 to 0.4
|
15 participants
Interval 0.21 to 0.49
|
15 participants
Interval 0.21 to 0.5
|
SECONDARY outcome
Timeframe: Measured at Days 90, 180, and 270 post-treatmentPopulation: All patients randomized were included in the analysis on an intent-to-treat basis
Immunosuppression discontinuation was defined as the discontinuation of corticosteroids and all additional immunosuppressives, except cyclosporine or tacrolimus, for treatment of acute GVHD without subsequent flare by Day 90 post-initiation of therapy and later by discontinuation of all immunosuppressive medications, including cyclosporine or tacrolimus.
Outcome measures
| Measure |
Etanercept
n=46 Participants
Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
|
Mycophenolate Mofetil
n=45 Participants
Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
|
Denileukin Diftitox
n=47 Participants
Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
|
Pentostatin
n=42 Participants
Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
|
|---|---|---|---|---|
|
Number of Patients Discontinuing Immune Suppression Without Flare
Day 90
|
7 participants
Interval 0.05 to 0.26
|
4 participants
Interval 0.01 to 0.17
|
5 participants
Interval 0.02 to 0.19
|
2 participants
Interval 0.0 to 0.11
|
|
Number of Patients Discontinuing Immune Suppression Without Flare
Day 180
|
12 participants
Interval 0.13 to 0.39
|
13 participants
Interval 0.16 to 0.42
|
8 participants
Interval 0.06 to 0.28
|
8 participants
Interval 0.07 to 0.31
|
|
Number of Patients Discontinuing Immune Suppression Without Flare
Day 270
|
16 participants
Interval 0.21 to 0.49
|
17 participants
Interval 0.24 to 0.52
|
10 participants
Interval 0.1 to 0.33
|
10 participants
Interval 0.11 to 0.37
|
SECONDARY outcome
Timeframe: Measured at 9 monthsPopulation: All patients randomized were included in the analysis on an intent-to-treat basis
Number of patients with limited and extensive chronic GVHD at 9 months
Outcome measures
| Measure |
Etanercept
n=46 Participants
Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
|
Mycophenolate Mofetil
n=45 Participants
Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
|
Denileukin Diftitox
n=47 Participants
Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
|
Pentostatin
n=42 Participants
Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
|
|---|---|---|---|---|
|
Number of Patients With Chronic Graft-versus-host Disease (GVHD)
|
11 participants
|
19 participants
|
15 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Measured at 6 and 9 monthsPopulation: All patients randomized were included in the analysis on an intent-to-treat basis
Outcome measures
| Measure |
Etanercept
n=46 Participants
Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
|
Mycophenolate Mofetil
n=45 Participants
Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
|
Denileukin Diftitox
n=47 Participants
Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
|
Pentostatin
n=42 Participants
Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
|
|---|---|---|---|---|
|
Number of Patients Surviving at 6 and 9 Months Post Randomization
Month 6
|
26 participants
Interval 0.43 to 0.72
|
32 participants
Interval 0.54 to 0.82
|
28 participants
Interval 0.47 to 0.76
|
24 participants
Interval 0.38 to 0.69
|
|
Number of Patients Surviving at 6 and 9 Months Post Randomization
Month 9
|
22 participants
Interval 0.32 to 0.61
|
29 participants
Interval 0.48 to 0.76
|
24 participants
Interval 0.34 to 0.62
|
21 participants
Interval 0.31 to 0.62
|
SECONDARY outcome
Timeframe: Measured at Day 270Outcome measures
| Measure |
Etanercept
n=46 Participants
Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
|
Mycophenolate Mofetil
n=45 Participants
Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
|
Denileukin Diftitox
n=47 Participants
Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
|
Pentostatin
n=42 Participants
Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
|
|---|---|---|---|---|
|
Cumulative Incidence of Systemic Infections
|
47 percentage of participants
Interval 33.0 to 63.0
|
44 percentage of participants
Interval 30.0 to 59.0
|
62 percentage of participants
Interval 48.0 to 76.0
|
57 percentage of participants
Interval 42.0 to 72.0
|
SECONDARY outcome
Timeframe: Measured at 9 monthsPopulation: No data collected
Outcome measures
Outcome data not reported
Adverse Events
Etanercept
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Mycophenolate Mofetil
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Denileukin Diftitox
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Pentostatin
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etanercept
n=46 participants at risk
Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
|
Mycophenolate Mofetil
n=45 participants at risk
Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
|
Denileukin Diftitox
n=47 participants at risk
Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
|
Pentostatin
n=42 participants at risk
Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/46 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/45 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/47 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
2.4%
1/42 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/46 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/45 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/47 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
2.4%
1/42 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
|
Gastrointestinal disorders
Intestinal perforation
|
2.2%
1/46 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/45 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/47 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/42 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/46 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/45 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
2.1%
1/47 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/42 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
|
General disorders
Adverse drug reaction
|
2.2%
1/46 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/45 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/47 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/42 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
|
General disorders
Pyrexia
|
0.00%
0/46 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/45 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
2.1%
1/47 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/42 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/46 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/45 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
2.1%
1/47 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/42 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/46 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
2.2%
1/45 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/47 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/42 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/46 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/45 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/47 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
2.4%
1/42 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
|
Nervous system disorders
Convulsion
|
0.00%
0/46 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/45 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/47 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
2.4%
1/42 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/46 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
2.2%
1/45 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/47 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/42 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/46 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/45 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/47 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
2.4%
1/42 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/46 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/45 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/47 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
2.4%
1/42 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/46 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
2.2%
1/45 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/47 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/42 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/46 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/45 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/47 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
2.4%
1/42 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.3%
2/46 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/45 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/47 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/42 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/46 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
0.00%
0/45 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
2.1%
1/47 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
2.4%
1/42 • Start of study through 9 months after randomization.
Unexpected Adverse Events Included
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place