Trial Outcomes & Findings for Efficacy and Safety Study of SyB L-0501 in Combination With Rituximab in Patients With Untreated, Low-grade B Cell Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma (NCT NCT01718691)
NCT ID: NCT01718691
Last Updated: 2016-04-27
Results Overview
The criteria for CR and CRu based on IWRC are shown below. CR: Fulfills all of the following * Disappearance of all detectable disease * LN\* \> 1.5 cm must decrease to ≤ 1.5 cm CRu: Fulfills all of the following * LN \>1.5 cm; SPD\*\* decrease \>75% * indeterminate bone marrow * LN: lymph nodes or nodal masses \*\* SPD: sum of the products of the greatest diameters
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Up to 30 weeks
Results posted on
2016-04-27
Participant Flow
Participant milestones
| Measure |
Low-grade B-cell Non-Hodgkin's Lymphoma
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma.
|
Mantle Cell Lymphoma
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
10
|
|
Overall Study
COMPLETED
|
42
|
9
|
|
Overall Study
NOT COMPLETED
|
18
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of SyB L-0501 in Combination With Rituximab in Patients With Untreated, Low-grade B Cell Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Low-grade B-cell Non-Hodgkin's Lymphoma
n=59 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
|
Mantle Cell Lymphoma
n=10 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
˂65 years
|
36 participants
n=5 Participants
|
0 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Age, Customized
≥65 years
|
23 participants
n=5 Participants
|
10 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Performance status (ECOG scale)
0
|
42 participants
n=5 Participants
|
7 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Performance status (ECOG scale)
1
|
16 participants
n=5 Participants
|
3 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Performance status (ECOG scale)
2
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Diagnosis (WHO classification)
Small lymphocytic lymphoma
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Diagnosis (WHO classification)
Lymphoplasmacytic lymphoma
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Diagnosis (WHO classification)
Splenic marginal zone lymphoma
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Diagnosis (WHO classification)
B-EMZL(MALT lymphoma)
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Diagnosis (WHO classification)
Nodal marginal zone B-cell lymphoma
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Diagnosis (WHO classification)
Follicular lymphoma
|
51 participants
n=5 Participants
|
0 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Diagnosis (WHO classification)
Mantle cell lymphoma
|
0 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Clinical stage (Ann Arbor staging classification)
I - II
|
15 participants
n=5 Participants
|
0 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Clinical stage (Ann Arbor staging classification)
III
|
9 participants
n=5 Participants
|
0 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Clinical stage (Ann Arbor staging classification)
IV
|
35 participants
n=5 Participants
|
10 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Number of lymph node regions
0 region
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Number of lymph node regions
1 region
|
12 participants
n=5 Participants
|
1 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Number of lymph node regions
2 regions
|
6 participants
n=5 Participants
|
1 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Number of lymph node regions
3 regions
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Number of lymph node regions
4 regions or more
|
37 participants
n=5 Participants
|
6 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Number of extranodal lesions
0 - 1 lesion
|
50 participants
n=5 Participants
|
4 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Number of extranodal lesions
2 or more lesions
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Tumor diameter (1)
≥5 cm
|
38 participants
n=5 Participants
|
4 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Tumor diameter (1)
˂5 cm
|
21 participants
n=5 Participants
|
6 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Tumor diameter (2)
≥7 cm
|
28 participants
n=5 Participants
|
1 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Tumor diameter (2)
˂7 cm
|
31 participants
n=5 Participants
|
9 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Lactate dehydrogenase (LDH)
≤ upper limit of normal range
|
45 participants
n=5 Participants
|
7 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Lactate dehydrogenase (LDH)
High
|
14 participants
n=5 Participants
|
3 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Beta 2 microglobulin
≤ upper limit of normal range
|
15 participants
n=5 Participants
|
3 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Beta 2 microglobulin
High
|
44 participants
n=5 Participants
|
7 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
C-reactive protein (CRP)
≤ upper limit of normal range
|
39 participants
n=5 Participants
|
8 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
C-reactive protein (CRP)
High
|
20 participants
n=5 Participants
|
2 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Hepatomegaly
Yes
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Hepatomegaly
No
|
56 participants
n=5 Participants
|
9 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Splenomegaly
Yes
|
19 participants
n=5 Participants
|
0 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Splenomegaly
No
|
40 participants
n=5 Participants
|
10 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Enlarged kidney
Yes
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Enlarged kidney
No
|
58 participants
n=5 Participants
|
10 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
B symptoms (fever)
Yes
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
B symptoms (fever)
No
|
59 participants
n=5 Participants
|
10 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
B symptoms (night sweats)
Yes
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
B symptoms (night sweats)
No
|
56 participants
n=5 Participants
|
10 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
B symptoms (weight loss)
Yes
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
B symptoms (weight loss)
No
|
57 participants
n=5 Participants
|
10 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Symptomatic splenomegaly
Yes
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Symptomatic splenomegaly
No
|
54 participants
n=5 Participants
|
10 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Pressure symptoms
Yes
|
14 participants
n=5 Participants
|
0 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Pressure symptoms
No
|
45 participants
n=5 Participants
|
10 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Pleural effusion/ascites retention
Yes
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Pleural effusion/ascites retention
No
|
54 participants
n=5 Participants
|
10 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Bone marrow invasion
Positive
|
34 participants
n=5 Participants
|
8 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Bone marrow invasion
Negative
|
24 participants
n=5 Participants
|
2 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Bone marrow invasion
Undetermined
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Chromosome abnormality
Yes
|
13 participants
n=5 Participants
|
4 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Chromosome abnormality
No
|
43 participants
n=5 Participants
|
5 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Chromosome abnormality
Unknown
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Previous medical history
Yes
|
31 participants
n=5 Participants
|
7 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Previous medical history
No
|
28 participants
n=5 Participants
|
3 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Concomitant disease
Yes
|
53 participants
n=5 Participants
|
10 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Concomitant disease
No
|
6 participants
n=5 Participants
|
0 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
FLIPI risk category
Low
|
17 participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
|
FLIPI risk category
Intermediate
|
24 participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
|
FLIPI risk category
High
|
18 participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
|
IPI risk category
Low
|
27 participants
n=5 Participants
|
0 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
IPI risk category
Intermediate (Low)
|
21 participants
n=5 Participants
|
2 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
IPI risk category
Intermediate (High)
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
IPI risk category
High
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 weeksThe criteria for CR and CRu based on IWRC are shown below. CR: Fulfills all of the following * Disappearance of all detectable disease * LN\* \> 1.5 cm must decrease to ≤ 1.5 cm CRu: Fulfills all of the following * LN \>1.5 cm; SPD\*\* decrease \>75% * indeterminate bone marrow * LN: lymph nodes or nodal masses \*\* SPD: sum of the products of the greatest diameters
Outcome measures
| Measure |
Low-grade B-cell Non-Hodgkin's Lymphoma
n=59 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
|
Mantle Cell Lymphoma
n=10 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
|
Total
n=69 Participants
All subjects in the SyB L-0501＋ rituximab arm
|
|---|---|---|---|
|
Complete Response Rate (CR + CRu) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)
|
67.8 percentage of participants
|
70.0 percentage of participants
|
68.1 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 30 weeksThe criteria for PR based on IWRC are shown below. PR: SPD regressed \> 50%
Outcome measures
| Measure |
Low-grade B-cell Non-Hodgkin's Lymphoma
n=59 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
|
Mantle Cell Lymphoma
n=10 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
|
Total
n=69 Participants
All subjects in the SyB L-0501＋ rituximab arm
|
|---|---|---|---|
|
Overall Response Rate (Antitumor Effect: PR or Better) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)
|
96.6 percentage of participants
|
90.0 percentage of participants
|
95.7 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 30 weeksThe criteria for CR based on the Revised RC are shown below. Definition: Disappearance of all evidence of disease Nodal Masses: 1. \[18F\]fluorodeoxyglucose (FDG)-avid or PET positive prior to therapy; mass of any size permitted if PET negative. 2. Variably FDG-avid or PET negative; regression to normal size on CT. Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative.
Outcome measures
| Measure |
Low-grade B-cell Non-Hodgkin's Lymphoma
n=59 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
|
Mantle Cell Lymphoma
n=10 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
|
Total
n=69 Participants
All subjects in the SyB L-0501＋ rituximab arm
|
|---|---|---|---|
|
Complete Response Rate (CR) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)
|
64.4 percentage of participants
|
80.0 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 30 weeksThe criteria for PR based on the Revised RC are shown below. Definition: Regression of measurable disease and no new sites Nodal Masses: 50% or more decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes 1. FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site 2. Variably FDG-avid or PET negative; regression on CT Spleen, Liver: 50% or more decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified.
Outcome measures
| Measure |
Low-grade B-cell Non-Hodgkin's Lymphoma
n=59 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
|
Mantle Cell Lymphoma
n=10 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
|
Total
n=69 Participants
All subjects in the SyB L-0501＋ rituximab arm
|
|---|---|---|---|
|
Overall Response Rate (PR or Better) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)
|
96.6 percentage of participants
|
90.0 percentage of participants
|
95.7 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 30 weeksThe criteria for Complete response based on WHO Handbook for Reporting Results of Cancer Treatment (1979) are shown below. Measurable disease: The disappearance of all known disease, determined by 2 observations not less than 4 weeks apart. Unmeasurable disease: Complete disappearance of all known disease for at least 4 weeks. Bone metastases: Complete disappearance of all lesions on X-ray or scan for at least 4 weeks.
Outcome measures
| Measure |
Low-grade B-cell Non-Hodgkin's Lymphoma
n=59 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
|
Mantle Cell Lymphoma
n=10 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
|
Total
n=69 Participants
All subjects in the SyB L-0501＋ rituximab arm
|
|---|---|---|---|
|
Complete Response Rate Based on WHO Handbook for Reporting Results of Cancer Treatment (1979)
|
22.0 percentage of participants
|
40.0 percentage of participants
|
24.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 30 weeksThe criteria for Overall response rate (PR or better) based on "WHO Handbook for Reporting Results of Cancer Treatment (1979)" are shown below. Definition of PR: Measurable disease: 50% or more decrease in total tumor size of the lesions which have been measured to determine the effect of therapy by 2 observations not less than 4 weeks apart. In addition there can be no appearance of new lesions or progression of any lesion. Unmeasurable disease: Estimated decrease in tumor size of 50% or more for at least 4 weeks. Bone metastases: Partial decrease in size of lytic lesions, recalcification of lytic lesions, or decreased density of blastic lesions for at least 4 weeks.
Outcome measures
| Measure |
Low-grade B-cell Non-Hodgkin's Lymphoma
n=59 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
|
Mantle Cell Lymphoma
n=10 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
|
Total
n=69 Participants
All subjects in the SyB L-0501＋ rituximab arm
|
|---|---|---|---|
|
Overall Response Rate (PR or Better) Based on "WHO Handbook for Reporting Results of Cancer Treatment (1979)"
|
86.4 percentage of participants
|
90.0 percentage of participants
|
87.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 30 weeksPFS is the period from registration date to the earliest onset date of any progression event calculated using the Kaplan-Meier estimator. The median and the 95% confidence interval (CI) were calculated using Greenwood's formula. Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause. The date of progression was determined based on overall response assessed using IWRC, Revised RC, and WHO, and assessment by the primary physicians (excluding overall response).
Outcome measures
| Measure |
Low-grade B-cell Non-Hodgkin's Lymphoma
n=59 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
|
Mantle Cell Lymphoma
n=10 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
|
Total
n=69 Participants
All subjects in the SyB L-0501＋ rituximab arm
|
|---|---|---|---|
|
Progression-Free Survival (PFS)
|
NA days
Interval 654.0 to
The PFS rate during this observation period was 57.7%, which was higher than 50% and therefore, 50% PFS could not be calculated.
|
NA days
The PFS rate during this observation period was 57.7%, which was higher than 50% and therefore, 50% PFS could not be calculated.
|
NA days
Interval 654.0 to
The PFS rate during this observation period was 57.7%, which was higher than 50% and therefore, 50% PFS could not be calculated.
|
SECONDARY outcome
Timeframe: Up to 30 weeksDOR is the period from the date of achieving CR, CRu or PR in the responders to the earliest onset date of any progression events calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood's formula. The date of achieving CR, CRu or PR was determined based on the overall response assessed using IWRC. The date of progression was determined based on overall response assessed using IWRC, Revised RC and WHO, and assessment by the primary physicians (excluding overall response). Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause.
Outcome measures
| Measure |
Low-grade B-cell Non-Hodgkin's Lymphoma
n=59 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
|
Mantle Cell Lymphoma
n=10 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
|
Total
n=69 Participants
All subjects in the SyB L-0501＋ rituximab arm
|
|---|---|---|---|
|
Duration of Response (DOR)
|
NA days
Interval 541.0 to
Because response was maintained in most subjects (of 66 subjects assessed as PR or better in the overall response assessment, eleven experienced a progression event).
|
NA days
Because response was maintained in most subjects (of 66 subjects assessed as PR or better in the overall response assessment, eleven experienced a progression event).
|
NA days
Interval 541.0 to
Because response was maintained in most subjects (of 66 subjects assessed as PR or better in the overall response assessment, eleven experienced a progression event).
|
SECONDARY outcome
Timeframe: Up to 30 weeksDeath due to any given cause was defined as an event. OS was calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood's formula.
Outcome measures
| Measure |
Low-grade B-cell Non-Hodgkin's Lymphoma
n=59 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
|
Mantle Cell Lymphoma
n=10 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
|
Total
n=69 Participants
All subjects in the SyB L-0501＋ rituximab arm
|
|---|---|---|---|
|
Overall Survival (OS)
|
NA days
Because no event of death occurred.
|
NA days
Because no event of death occurred.
|
NA days
Because no event of death occurred.
|
SECONDARY outcome
Timeframe: up to 30 weeksAdverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA) Ver.16.1.
Outcome measures
| Measure |
Low-grade B-cell Non-Hodgkin's Lymphoma
n=69 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
|
Mantle Cell Lymphoma
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
|
Total
All subjects in the SyB L-0501＋ rituximab arm
|
|---|---|---|---|
|
Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Discontinuation Due to Adverse Event
Any adverse event
|
69 participants
|
—
|
—
|
|
Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Discontinuation Due to Adverse Event
Adverse drug reaction
|
69 participants
|
—
|
—
|
|
Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Discontinuation Due to Adverse Event
SAE
|
9 participants
|
—
|
—
|
|
Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Discontinuation Due to Adverse Event
Death
|
0 participants
|
—
|
—
|
|
Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Discontinuation Due to Adverse Event
Discontinuation due to adverse events
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 30 weeksAbnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE
Outcome measures
| Measure |
Low-grade B-cell Non-Hodgkin's Lymphoma
n=69 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
|
Mantle Cell Lymphoma
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
|
Total
All subjects in the SyB L-0501＋ rituximab arm
|
|---|---|---|---|
|
Laboratory Test Abnormalities (Biochemical Tests)
Grade 3 : AST(GOT)
|
3 participants
|
—
|
—
|
|
Laboratory Test Abnormalities (Biochemical Tests)
Grade 3 : ALT(GPT)
|
3 participants
|
—
|
—
|
|
Laboratory Test Abnormalities (Biochemical Tests)
Grade 3 : γ-GTP
|
1 participants
|
—
|
—
|
|
Laboratory Test Abnormalities (Biochemical Tests)
Grade 4 : Uric acid
|
1 participants
|
—
|
—
|
|
Laboratory Test Abnormalities (Biochemical Tests)
Grade 3 : Na decrease
|
1 participants
|
—
|
—
|
|
Laboratory Test Abnormalities (Biochemical Tests)
Grade 3 : K decrease
|
2 participants
|
—
|
—
|
|
Laboratory Test Abnormalities (Biochemical Tests)
Grade 3 : K increase
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 30 weeksAbnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE
Outcome measures
| Measure |
Low-grade B-cell Non-Hodgkin's Lymphoma
n=69 Participants
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
|
Mantle Cell Lymphoma
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
|
Total
All subjects in the SyB L-0501＋ rituximab arm
|
|---|---|---|---|
|
Laboratory Test Abnormalities (Hematology Tests)
Grade 3 : White blood cell count decreased
|
45 participants
|
—
|
—
|
|
Laboratory Test Abnormalities (Hematology Tests)
Grade 4 : White blood cell count decreased
|
12 participants
|
—
|
—
|
|
Laboratory Test Abnormalities (Hematology Tests)
Grade 3 : Neutrophil count decreased
|
25 participants
|
—
|
—
|
|
Laboratory Test Abnormalities (Hematology Tests)
Grade 4 : Neutrophil count decreased
|
34 participants
|
—
|
—
|
|
Laboratory Test Abnormalities (Hematology Tests)
Grade 3 : Lymphocyte count decreased
|
6 participants
|
—
|
—
|
|
Laboratory Test Abnormalities (Hematology Tests)
Grade 4 : Lymphocyte count decreased
|
63 participants
|
—
|
—
|
|
Laboratory Test Abnormalities (Hematology Tests)
Grade 3 : Haemoglobin decreased
|
5 participants
|
—
|
—
|
|
Laboratory Test Abnormalities (Hematology Tests)
Grade 3 : Platelet count decreased
|
3 participants
|
—
|
—
|
|
Laboratory Test Abnormalities (Hematology Tests)
Grade 4 : Platelet count decreased
|
2 participants
|
—
|
—
|
Adverse Events
SyB L-0501＋Rituximab
Serious events: 9 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SyB L-0501＋Rituximab
n=69 participants at risk
Drug: SyB L-0501
A dose of 90 mg/m\^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times.
Drug: rituximab
A dose of 375 mg/m\^2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
3/69
|
|
Metabolism and nutrition disorders
tumour lysis syndrome
|
1.4%
1/69
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.4%
1/69
|
|
Infections and infestations
pneumonia cytomegaloviral
|
1.4%
1/69
|
|
Skin and subcutaneous tissue disorders
dermatitis allergic
|
1.4%
1/69
|
|
Congenital, familial and genetic disorders
cytogenetic abnormality
|
1.4%
1/69
|
|
Cardiac disorders
atrial tachycardia
|
1.4%
1/69
|
|
General disorders
pyrexia
|
1.4%
1/69
|
Other adverse events
| Measure |
SyB L-0501＋Rituximab
n=69 participants at risk
Drug: SyB L-0501
A dose of 90 mg/m\^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times.
Drug: rituximab
A dose of 375 mg/m\^2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0.
|
|---|---|
|
Infections and infestations
Bronchitis
|
1.4%
1/69
|
|
Infections and infestations
Cellulitis
|
1.4%
1/69
|
|
Infections and infestations
Chronic sinusitis
|
1.4%
1/69
|
|
Blood and lymphatic system disorders
Anaemia
|
34.8%
24/69
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/69
|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.3%
3/69
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
1.4%
1/69
|
|
Cardiac disorders
Cardiac failure
|
1.4%
1/69
|
|
Cardiac disorders
Sinus bradycardia
|
4.3%
3/69
|
|
Cardiac disorders
Ventricular arrhythmia
|
2.9%
2/69
|
|
Ear and labyrinth disorders
Tinnitus
|
1.4%
1/69
|
|
Ear and labyrinth disorders
Vertigo
|
1.4%
1/69
|
|
Ear and labyrinth disorders
External ear inflammation
|
1.4%
1/69
|
|
Endocrine disorders
Steroid withdrawal syndrome
|
1.4%
1/69
|
|
Eye disorders
Asthenopia
|
1.4%
1/69
|
|
Eye disorders
Conjunctivitis
|
2.9%
2/69
|
|
Eye disorders
Dry eye
|
1.4%
1/69
|
|
Eye disorders
Erythema of eyelid
|
1.4%
1/69
|
|
Eye disorders
Scintillating scotoma
|
1.4%
1/69
|
|
Eye disorders
Trichiasis
|
1.4%
1/69
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.4%
1/69
|
|
Gastrointestinal disorders
Abdominal distension
|
1.4%
1/69
|
|
Gastrointestinal disorders
Anal fissure
|
1.4%
1/69
|
|
Gastrointestinal disorders
Cheilitis
|
5.8%
4/69
|
|
Gastrointestinal disorders
Colitis ischaemic
|
1.4%
1/69
|
|
Gastrointestinal disorders
Constipation
|
65.2%
45/69
|
|
Gastrointestinal disorders
Dental caries
|
1.4%
1/69
|
|
Gastrointestinal disorders
Diarrhoea
|
15.9%
11/69
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
2/69
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
1/69
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.4%
1/69
|
|
Gastrointestinal disorders
Nausea
|
66.7%
46/69
|
|
Gastrointestinal disorders
Oesophageal pain
|
1.4%
1/69
|
|
Gastrointestinal disorders
Proctalgia
|
1.4%
1/69
|
|
Gastrointestinal disorders
Stomatitis
|
21.7%
15/69
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
13/69
|
|
General disorders
Chest discomfort
|
1.4%
1/69
|
|
General disorders
Chest pain
|
8.7%
6/69
|
|
General disorders
Chills
|
1.4%
1/69
|
|
General disorders
Fatigue
|
8.7%
6/69
|
|
General disorders
Injection site bruising
|
1.4%
1/69
|
|
General disorders
Injection site induration
|
1.4%
1/69
|
|
General disorders
Injection site pain
|
11.6%
8/69
|
|
General disorders
Injection site phlebitis
|
1.4%
1/69
|
|
General disorders
Injection site reaction
|
11.6%
8/69
|
|
General disorders
Local swelling
|
1.4%
1/69
|
|
General disorders
Malaise
|
53.6%
37/69
|
|
General disorders
Oedema
|
4.3%
3/69
|
|
General disorders
Oedema peripheral
|
4.3%
3/69
|
|
General disorders
Pain
|
2.9%
2/69
|
|
General disorders
Pyrexia
|
24.6%
17/69
|
|
General disorders
Thirst
|
1.4%
1/69
|
|
General disorders
Injection site swelling
|
1.4%
1/69
|
|
General disorders
Non-cardiac chest pain
|
1.4%
1/69
|
|
General disorders
Infusion site extravasation
|
1.4%
1/69
|
|
General disorders
Injection site vasculitis
|
1.4%
1/69
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.9%
2/69
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
7.2%
5/69
|
|
Hepatobiliary disorders
Liver disorder
|
1.4%
1/69
|
|
Hepatobiliary disorders
Gallbladder polyp
|
1.4%
1/69
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
2.9%
2/69
|
|
Immune system disorders
Drug hypersensitivity
|
1.4%
1/69
|
|
Immune system disorders
Hypersensitivity
|
4.3%
3/69
|
|
Immune system disorders
Hypogammaglobulinaemia
|
1.4%
1/69
|
|
Immune system disorders
Sarcoidosis
|
1.4%
1/69
|
|
Infections and infestations
Cystitis
|
2.9%
2/69
|
|
Infections and infestations
Cytomegalovirus infection
|
1.4%
1/69
|
|
Infections and infestations
Folliculitis
|
1.4%
1/69
|
|
Infections and infestations
Gastroenteritis
|
2.9%
2/69
|
|
Infections and infestations
Hepatitis viral
|
1.4%
1/69
|
|
Infections and infestations
Herpes simplex
|
1.4%
1/69
|
|
Infections and infestations
Herpes zoster
|
1.4%
1/69
|
|
Infections and infestations
Infection
|
1.4%
1/69
|
|
Infections and infestations
Laryngitis
|
1.4%
1/69
|
|
Infections and infestations
Nasopharyngitis
|
20.3%
14/69
|
|
Infections and infestations
Oral candidiasis
|
2.9%
2/69
|
|
Infections and infestations
Paronychia
|
1.4%
1/69
|
|
Infections and infestations
Pneumonia
|
1.4%
1/69
|
|
Infections and infestations
Rhinitis
|
1.4%
1/69
|
|
Infections and infestations
Sinusitis
|
1.4%
1/69
|
|
Infections and infestations
Skin infection
|
1.4%
1/69
|
|
Infections and infestations
Upper respiratory tract infection
|
7.2%
5/69
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/69
|
|
Infections and infestations
Viral infection
|
2.9%
2/69
|
|
Infections and infestations
Cytomegalovirus viraemia
|
1.4%
1/69
|
|
Infections and infestations
Bacterial infection
|
1.4%
1/69
|
|
Infections and infestations
Acarodermatitis
|
1.4%
1/69
|
|
Infections and infestations
Aspergillus infection
|
1.4%
1/69
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
2.9%
2/69
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
40.6%
28/69
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.4%
1/69
|
|
Investigations
Alanine aminotransferase increased
|
26.1%
18/69
|
|
Investigations
Amylase increased
|
1.4%
1/69
|
|
Investigations
Aspartate aminotransferase increased
|
31.9%
22/69
|
|
Investigations
Beta 2 microglobulin increased
|
4.3%
3/69
|
|
Investigations
Blood albumin decreased
|
7.2%
5/69
|
|
Investigations
Blood bilirubin increased
|
4.3%
3/69
|
|
Investigations
Blood creatinine increased
|
7.2%
5/69
|
|
Investigations
Blood immunoglobulin A decreased
|
30.4%
21/69
|
|
Investigations
Blood immunoglobulin G decreased
|
30.4%
21/69
|
|
Investigations
Blood immunoglobulin M decreased
|
46.4%
32/69
|
|
Investigations
Blood lactate dehydrogenase increased
|
31.9%
22/69
|
|
Investigations
Blood potassium decreased
|
1.4%
1/69
|
|
Investigations
Blood urea increased
|
1.4%
1/69
|
|
Investigations
Blood uric acid increased
|
4.3%
3/69
|
|
Investigations
C-reactive protein increased
|
26.1%
18/69
|
|
Investigations
CD4 lymphocytes decreased
|
92.8%
64/69
|
|
Investigations
Electrocardiogram QT prolonged
|
2.9%
2/69
|
|
Investigations
Eosinophil count increased
|
15.9%
11/69
|
|
Investigations
Gamma-glutamyltransferase increased
|
21.7%
15/69
|
|
Investigations
Blood urine present
|
1.4%
1/69
|
|
Investigations
Haemoglobin decreased
|
10.1%
7/69
|
|
Investigations
Low density lipoprotein increased
|
1.4%
1/69
|
|
Investigations
Lymphocyte count decreased
|
97.1%
67/69
|
|
Investigations
Lymphocyte count increased
|
1.4%
1/69
|
|
Investigations
Monocyte count decreased
|
1.4%
1/69
|
|
Investigations
Neutrophil count decreased
|
94.2%
65/69
|
|
Investigations
Neutrophil count increased
|
13.0%
9/69
|
|
Investigations
Platelet count decreased
|
55.1%
38/69
|
|
Investigations
Protein total decreased
|
11.6%
8/69
|
|
Investigations
Protein urine
|
1.4%
1/69
|
|
Investigations
Red blood cell count decreased
|
13.0%
9/69
|
|
Investigations
Weight decreased
|
13.0%
9/69
|
|
Investigations
Weight increased
|
7.2%
5/69
|
|
Investigations
White blood cell count decreased
|
100.0%
69/69
|
|
Investigations
White blood cell count increased
|
8.7%
6/69
|
|
Investigations
Blood bilirubin decreased
|
1.4%
1/69
|
|
Investigations
Neutrophil percentage decreased
|
1.4%
1/69
|
|
Investigations
Neutrophil percentage increased
|
1.4%
1/69
|
|
Investigations
Electrocardiogram ST-T segment abnormal
|
1.4%
1/69
|
|
Investigations
Blood alkaline phosphatase increased
|
18.8%
13/69
|
|
Investigations
Occult blood
|
1.4%
1/69
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/69
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.4%
1/69
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.4%
1/69
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.8%
4/69
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.4%
1/69
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
4.3%
3/69
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.4%
1/69
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.4%
1/69
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.4%
1/69
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.9%
2/69
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.4%
1/69
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
2.9%
2/69
|
|
Metabolism and nutrition disorders
Decreased appetite
|
43.5%
30/69
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.2%
5/69
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.2%
5/69
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.4%
1/69
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.9%
2/69
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.4%
1/69
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/69
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
1.4%
1/69
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
1.4%
1/69
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
4.3%
3/69
|
|
Nervous system disorders
Dizziness
|
4.3%
3/69
|
|
Nervous system disorders
Dizziness postural
|
1.4%
1/69
|
|
Nervous system disorders
Dysgeusia
|
18.8%
13/69
|
|
Nervous system disorders
Headache
|
17.4%
12/69
|
|
Nervous system disorders
Neuropathy peripheral
|
2.9%
2/69
|
|
Nervous system disorders
Paraesthesia
|
1.4%
1/69
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.4%
1/69
|
|
Nervous system disorders
Sensory disturbance
|
1.4%
1/69
|
|
Nervous system disorders
Tremor
|
1.4%
1/69
|
|
Nervous system disorders
Lacunar infarction
|
1.4%
1/69
|
|
Psychiatric disorders
Insomnia
|
27.5%
19/69
|
|
Renal and urinary disorders
Haematuria
|
2.9%
2/69
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.4%
1/69
|
|
Renal and urinary disorders
Pollakiuria
|
4.3%
3/69
|
|
Renal and urinary disorders
Urinary retention
|
1.4%
1/69
|
|
Reproductive system and breast disorders
Breast swelling
|
1.4%
1/69
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
3/69
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
1/69
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.4%
1/69
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.8%
4/69
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/69
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.4%
1/69
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.4%
1/69
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
8.7%
6/69
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
5.8%
4/69
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.3%
3/69
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.9%
2/69
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.4%
1/69
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.4%
1/69
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
2.9%
2/69
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
2.9%
2/69
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.9%
2/69
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.4%
1/69
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
1.4%
1/69
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.4%
1/69
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.4%
1/69
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
1.4%
1/69
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
1.4%
1/69
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.4%
1/69
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
1.4%
1/69
|
|
Skin and subcutaneous tissue disorders
Papule
|
1.4%
1/69
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.8%
13/69
|
|
Skin and subcutaneous tissue disorders
Rash
|
42.0%
29/69
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.1%
7/69
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.9%
2/69
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
1.4%
1/69
|
|
Surgical and medical procedures
Tooth extraction
|
1.4%
1/69
|
|
Vascular disorders
Flushing
|
5.8%
4/69
|
|
Vascular disorders
Hypertension
|
1.4%
1/69
|
|
Vascular disorders
Hypotension
|
2.9%
2/69
|
|
Vascular disorders
Orthostatic hypotension
|
1.4%
1/69
|
|
Vascular disorders
Phlebitis
|
5.8%
4/69
|
|
Vascular disorders
Vascular pain
|
15.9%
11/69
|
|
Vascular disorders
Vasculitis
|
29.0%
20/69
|
|
Vascular disorders
Hot flush
|
1.4%
1/69
|
Additional Information
Toshihiko Nagase
SymBio Pharmaceuticals
Phone: +81-3-5472-1125
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place