Trial Outcomes & Findings for Efficacy and Safety Study of SyB L-0501 for Patients With Chronic Lymphocytic Leukemia (NCT NCT02042911)
NCT ID: NCT02042911
Last Updated: 2017-02-01
Results Overview
The criteria for CR, CRi, nPR and PR based on IWCLL guideline are shown below. For the criteria for nPR and PR, please refer to the description of NCI-WG response rate (CR+nPR+PR). CR: Assessment should be made at least 8 weeks after completion of administration. 1. Absence of significant lymphadenopathy (lymph nodes greater than 1.5 cm in diameter) 2. No hepatomegaly or splenomegaly 3. Absence of B symptoms 4. Meet the following laboratory test values; * lymphocyte count in peripheral blood: \<4.0×10\^9/L * neutrophil count: \>1.5×10\^9/L * platelet count: 100×10\^9/L * hemoglobin: 11.0 g/dL without transfusions 5. less than 30% of nucleated cells are lymphocytes (confirmed by bone marrow aspiration and no lymphoid nodules). 6. No new lesion emergence CRi: Fulfills all of the following criteria * Delayed anemia, thrombocytopenia, or neutropenia is observed. * Fulfills all CR criteria other than 4). * Delayed symptoms are all judged to be caused by drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Up to 30 months
Results posted on
2017-02-01
Participant Flow
Participant milestones
| Measure |
SyB L-0501
SyB L-0501: SyB L-0501 is administered at 100 mg/m\^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of SyB L-0501 for Patients With Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
SyB L-0501
n=10 Participants
SyB L-0501: SyB L-0501 is administered at 100 mg/m\^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
|
|---|---|
|
Age, Customized
<65 years
|
2 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
8 participants
n=5 Participants
|
|
Gender
Female
|
4 Participants
n=5 Participants
|
|
Gender
Male
|
6 Participants
n=5 Participants
|
|
Prior therapy
Absent
|
8 participants
n=5 Participants
|
|
Prior therapy
Present
|
2 participants
n=5 Participants
|
|
ECOG performance status
0
|
8 participants
n=5 Participants
|
|
ECOG performance status
1
|
2 participants
n=5 Participants
|
|
ECOG performance status
2
|
0 participants
n=5 Participants
|
|
Clinical disease stage (Binet Staging System)
A
|
0 participants
n=5 Participants
|
|
Clinical disease stage (Binet Staging System)
B
|
3 participants
n=5 Participants
|
|
Clinical disease stage (Binet Staging System)
C
|
7 participants
n=5 Participants
|
|
Medical history
Absent
|
4 participants
n=5 Participants
|
|
Medical history
Present
|
6 participants
n=5 Participants
|
|
Complication
Absent
|
1 participants
n=5 Participants
|
|
Complication
Present
|
9 participants
n=5 Participants
|
|
Fluorescence in situ hybridization (FISH) detection of trisomy 12
Absent
|
8 participants
n=5 Participants
|
|
Fluorescence in situ hybridization (FISH) detection of trisomy 12
Present
|
2 participants
n=5 Participants
|
|
FISH detection of del (13q14)
Absent
|
5 participants
n=5 Participants
|
|
FISH detection of del (13q14)
Present
|
5 participants
n=5 Participants
|
|
FISH detection of del (11q22-23)
Absent
|
10 participants
n=5 Participants
|
|
FISH detection of del (11q22-23)
Present
|
0 participants
n=5 Participants
|
|
FISH detection of del (17p13)
Absent
|
10 participants
n=5 Participants
|
|
FISH detection of del (17p13)
Present
|
0 participants
n=5 Participants
|
|
FISH detection of immunoglobulin heavy chain (IgH)/CyclinD1 (CCND1) (BCL1) t (11; 14)
Absent
|
10 participants
n=5 Participants
|
|
FISH detection of immunoglobulin heavy chain (IgH)/CyclinD1 (CCND1) (BCL1) t (11; 14)
Present
|
0 participants
n=5 Participants
|
|
Somatic hypermutation (SHM) analysis of immunoglobulin heavy chain variable (IgVH) genes
Absent
|
1 participants
n=5 Participants
|
|
Somatic hypermutation (SHM) analysis of immunoglobulin heavy chain variable (IgVH) genes
Present
|
9 participants
n=5 Participants
|
|
Diagnosis of chronic lymphocytic leukemia (CLL)
Yes
|
10 participants
n=5 Participants
|
|
Diagnosis of chronic lymphocytic leukemia (CLL)
No
|
0 participants
n=5 Participants
|
|
Lymphadenopathy
Absent
|
2 participants
n=5 Participants
|
|
Lymphadenopathy
Present
|
8 participants
n=5 Participants
|
|
Hepatomegaly
Absent
|
5 participants
n=5 Participants
|
|
Hepatomegaly
Present
|
5 participants
n=5 Participants
|
|
Splenomegaly
Absent
|
1 participants
n=5 Participants
|
|
Splenomegaly
Present
|
9 participants
n=5 Participants
|
|
B symptoms (Weight Loss)
Absent
|
10 participants
n=5 Participants
|
|
B symptoms (Weight Loss)
Present
|
0 participants
n=5 Participants
|
|
B symptoms (Fever)
Absent
|
10 participants
n=5 Participants
|
|
B symptoms (Fever)
Present
|
0 participants
n=5 Participants
|
|
B symptoms (Night Sweats)
Absent
|
8 participants
n=5 Participants
|
|
B symptoms (Night Sweats)
Present
|
2 participants
n=5 Participants
|
|
Presence of cluster of differentiation (CD) 5 antigen
Negative (-)
|
0 participants
n=5 Participants
|
|
Presence of cluster of differentiation (CD) 5 antigen
Positive (+)
|
10 participants
n=5 Participants
|
|
Presence of CD19 antigen
Negative (-)
|
0 participants
n=5 Participants
|
|
Presence of CD19 antigen
Positive (+)
|
10 participants
n=5 Participants
|
|
Presence of CD20 antigen
Negative (-)
|
0 participants
n=5 Participants
|
|
Presence of CD20 antigen
Positive (+)
|
10 participants
n=5 Participants
|
|
Presence of CD23 antigen
Negative (-)
|
2 participants
n=5 Participants
|
|
Presence of CD23 antigen
Positive (+)
|
8 participants
n=5 Participants
|
|
Presence of Igκ
Negative (-)
|
4 participants
n=5 Participants
|
|
Presence of Igκ
Positive (+)
|
6 participants
n=5 Participants
|
|
Presence of Igλ
Negative (-)
|
6 participants
n=5 Participants
|
|
Presence of Igλ
Positive (+)
|
4 participants
n=5 Participants
|
|
Marrow examination for lymphoid nodules
Absent
|
5 participants
n=5 Participants
|
|
Marrow examination for lymphoid nodules
Present
|
5 participants
n=5 Participants
|
|
Marrow examination for infiltration
Absent
|
1 participants
n=5 Participants
|
|
Marrow examination for infiltration
Present
|
9 participants
n=5 Participants
|
|
Height
|
162.03 cm
STANDARD_DEVIATION 5.03 • n=5 Participants
|
|
Body weight
|
56.51 kg
STANDARD_DEVIATION 9.43 • n=5 Participants
|
|
Body surface area
|
1.592 m^2
STANDARD_DEVIATION 0.134 • n=5 Participants
|
|
Age
|
69.8 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 monthsThe criteria for CR, CRi, nPR and PR based on IWCLL guideline are shown below. For the criteria for nPR and PR, please refer to the description of NCI-WG response rate (CR+nPR+PR). CR: Assessment should be made at least 8 weeks after completion of administration. 1. Absence of significant lymphadenopathy (lymph nodes greater than 1.5 cm in diameter) 2. No hepatomegaly or splenomegaly 3. Absence of B symptoms 4. Meet the following laboratory test values; * lymphocyte count in peripheral blood: \<4.0×10\^9/L * neutrophil count: \>1.5×10\^9/L * platelet count: 100×10\^9/L * hemoglobin: 11.0 g/dL without transfusions 5. less than 30% of nucleated cells are lymphocytes (confirmed by bone marrow aspiration and no lymphoid nodules). 6. No new lesion emergence CRi: Fulfills all of the following criteria * Delayed anemia, thrombocytopenia, or neutropenia is observed. * Fulfills all CR criteria other than 4). * Delayed symptoms are all judged to be caused by drug.
Outcome measures
| Measure |
SyB L-0501
n=10 Participants
SyB L-0501: SyB L-0501 is administered at 100 mg/m\^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
|
|---|---|
|
Response Rate [Complete Remission (CR) +Complete Remission / Incomplete (CRi) + Nodular Partial Remission (nPR) + Partial Remission (PR)] Based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guideline
|
60.0 Percentage of participants
Interval 26.2 to 87.8
|
SECONDARY outcome
Timeframe: Up to 30 monthsThe criteria for nPR and PR based on IWCLL guideline are shown below. nPR: Fulfills all CR criteria other than residual lymphoid nodules confirmed by bone marrow examination. PR: Fulfills two or more items from Group A and one or more items from Group B for a minimal duration of 8 weeks. Group A; 1. 50% or greater reduction in lymphocyte count in peripheral blood from baseline 2. 50% or greater reduction (size reduction) in Sum of the products of the greatest diameters (SPD) and no new lesion emergence or no new enlarged lymph node 3. A decrease in the size of the liver and/or spleen by 50% more 4. A decrease in marrow infiltration or lymphoid nodules by 50% more Group B; 1\) Neutrophil count \>1.5×10\^9/L or 50% improvement from baseline 2) Platelet count \>100×10\^9/L or 50% improvement from baseline 3) Hemoglobin 11.0 g/dL or 50% improvement from baseline without transfusions
Outcome measures
| Measure |
SyB L-0501
n=10 Participants
SyB L-0501: SyB L-0501 is administered at 100 mg/m\^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
|
|---|---|
|
National Cancer Institute-sponsored Working Group (NCI-WG) Response Rate (CR+nPR+PR) Based on IWCLL Guideline
|
60.0 Percentage of participants
Interval 26.2 to 87.8
|
SECONDARY outcome
Timeframe: Up to 30 monthsOutcome measures
| Measure |
SyB L-0501
n=10 Participants
SyB L-0501: SyB L-0501 is administered at 100 mg/m\^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
|
|---|---|
|
Complete Remission Rate (CR+CRi) Based on IWCLL Guideline
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
SECONDARY outcome
Timeframe: Up to 30 monthsThe period from the first day of the study drug administration (Day1) to progressive disease (PD), recurrence/relapse, or death.
Outcome measures
| Measure |
SyB L-0501
n=10 Participants
SyB L-0501: SyB L-0501 is administered at 100 mg/m\^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
|
|---|---|
|
Progression-free Survival (PFS)
|
NA months
Because no events were reported at the time of analysis for PFS.
|
SECONDARY outcome
Timeframe: Up to 30 monthsThe period from the day of CR or PR confirmation to recurrence/relapse.
Outcome measures
| Measure |
SyB L-0501
n=10 Participants
SyB L-0501: SyB L-0501 is administered at 100 mg/m\^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
|
|---|---|
|
Duration of Remission
|
NA months
Because no events were reported at the time of analysis for the duration of remission.
|
SECONDARY outcome
Timeframe: Up to 30 monthsThe period from the date of patient registration to the date of death.
Outcome measures
| Measure |
SyB L-0501
n=10 Participants
SyB L-0501: SyB L-0501 is administered at 100 mg/m\^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
|
|---|---|
|
Overall Survival (OS)
|
NA months
Because no events were reported at the time of analysis for OS.
|
SECONDARY outcome
Timeframe: Up to 30 monthsAll undesirable medical events experienced by the subject treated with the investigational product (including abnormal changes in laboratory values) are treated as adverse events and evaluated for safety.
Outcome measures
| Measure |
SyB L-0501
n=10 Participants
SyB L-0501: SyB L-0501 is administered at 100 mg/m\^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
|
|---|---|
|
Adverse Events
Any adverse event
|
10 participants
|
|
Adverse Events
Adverse drug reaction
|
10 participants
|
|
Adverse Events
SAE
|
3 participants
|
|
Adverse Events
Death
|
0 participants
|
|
Adverse Events
Discontinuation due to adverse events
|
1 participants
|
|
Adverse Events
Dose reduction due to adverse events
|
5 participants
|
SECONDARY outcome
Timeframe: Up to 30 monthsAbnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (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 adverse event
Outcome measures
| Measure |
SyB L-0501
n=10 Participants
SyB L-0501: SyB L-0501 is administered at 100 mg/m\^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
|
|---|---|
|
Number of Subjects With Clinically Significant Laboratory Test Values of Grade 3 or More
CD4 lymphocytes decreased
|
8 participants
|
|
Number of Subjects With Clinically Significant Laboratory Test Values of Grade 3 or More
Hyperglycemia
|
1 participants
|
|
Number of Subjects With Clinically Significant Laboratory Test Values of Grade 3 or More
White blood cell decreased
|
7 participants
|
|
Number of Subjects With Clinically Significant Laboratory Test Values of Grade 3 or More
Lymphocyte count decreased
|
9 participants
|
|
Number of Subjects With Clinically Significant Laboratory Test Values of Grade 3 or More
Neutrophil count decreased
|
8 participants
|
|
Number of Subjects With Clinically Significant Laboratory Test Values of Grade 3 or More
Platelet count decreased
|
2 participants
|
SECONDARY outcome
Timeframe: Up to 30 monthsNumber of subjects with abnormal or severe values of vital signs, electrocardiogram, and physical examination including ECOG performance status
Outcome measures
| Measure |
SyB L-0501
n=10 Participants
SyB L-0501: SyB L-0501 is administered at 100 mg/m\^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
|
|---|---|
|
Number of Subjects With Clinically Significant Physical Examination Values
Vital signs
|
0 participants
|
|
Number of Subjects With Clinically Significant Physical Examination Values
Electrocardiogram
|
0 participants
|
|
Number of Subjects With Clinically Significant Physical Examination Values
Physical examination
|
0 participants
|
Adverse Events
SyB L-0501
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SyB L-0501
n=10 participants at risk
SyB L-0501: SyB L-0501 is administered at 100 mg/m\^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
|
|---|---|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Bacterial infection
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Cytomegaloviral infection
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Adenocarcinoma gastric
|
10.0%
1/10 • Number of events 1
|
Other adverse events
| Measure |
SyB L-0501
n=10 participants at risk
SyB L-0501: SyB L-0501 is administered at 100 mg/m\^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
1/10 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
80.0%
8/10 • Number of events 8
|
|
Gastrointestinal disorders
Xerostomia
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
80.0%
8/10 • Number of events 8
|
|
Gastrointestinal disorders
Stomatitis
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Allergic colitis
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Fatigue
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Malaise
|
50.0%
5/10 • Number of events 5
|
|
General disorders
Oedema peripheral
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Pain
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Pyrexia
|
20.0%
2/10 • Number of events 2
|
|
Immune system disorders
Hypogammaglobulinemia
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Conjunctivitis
|
20.0%
2/10 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Oral candidosis
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Limb injury
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pain caused by treatment
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
2/10 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
4/10 • Number of events 4
|
|
Investigations
Blood albumin decreased
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Blood glucose increased
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Blood immunogloblin A decreased
|
30.0%
3/10 • Number of events 3
|
|
Investigations
Blood immunogloblin G decreased
|
30.0%
3/10 • Number of events 3
|
|
Investigations
Blood immunogloblin M decreased
|
30.0%
3/10 • Number of events 3
|
|
Investigations
Blood lactate dehydrogenase increased
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Blood urea increased
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Blood uric acid decreased
|
20.0%
2/10 • Number of events 2
|
|
Investigations
CD4 lymphocytes decreased
|
100.0%
10/10 • Number of events 10
|
|
Investigations
Electrocardiogram QT prolonged
|
20.0%
2/10 • Number of events 2
|
|
Investigations
Gamma-glutamyltransferase increased
|
20.0%
2/10 • Number of events 2
|
|
Investigations
Hematocrit decreased
|
20.0%
2/10 • Number of events 2
|
|
Investigations
Haemoglobin decreased
|
20.0%
2/10 • Number of events 2
|
|
Investigations
Lymphocyte count decreased
|
90.0%
9/10 • Number of events 9
|
|
Investigations
Neutrophil count decreased
|
100.0%
10/10 • Number of events 10
|
|
Investigations
Neutrophil count increased
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Platelet count decreased
|
90.0%
9/10 • Number of events 9
|
|
Investigations
Red blood cell count decreased
|
20.0%
2/10 • Number of events 2
|
|
Investigations
Reticulocyte decreased
|
20.0%
2/10 • Number of events 2
|
|
Investigations
Weight decreased
|
10.0%
1/10 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
90.0%
9/10 • Number of events 9
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
5/10 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
2/10 • Number of events 2
|
|
Nervous system disorders
Positional vertigo
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
20.0%
2/10 • Number of events 2
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
2/10 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Acneform dermatitis
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.0%
3/10 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
2/10 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
30.0%
3/10 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
20.0%
2/10 • Number of events 2
|
|
Vascular disorders
Hypertension
|
20.0%
2/10 • Number of events 2
|
|
Vascular disorders
Phlebitis
|
20.0%
2/10 • Number of events 2
|
|
Vascular disorders
Angialgia
|
20.0%
2/10 • Number of events 2
|
|
Vascular disorders
Angiitis
|
10.0%
1/10 • Number of events 1
|
Additional Information
Toshihiko Nagase
SymBio Pharmaceuticals
Phone: +81-3-5472-1127
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place