Trial Outcomes & Findings for Study of SyB L-0501 to Treat Relapsed/Refractory Multiple Myeloma (NCT NCT01849848)

NCT ID: NCT01849848

Last Updated: 2015-02-06

Results Overview

The criteria for sCR, CR, VGPR, and PR based on IMWG are shown below. sCR: Fulfills CR criteria as well as all of the following conditions * Normal free light chain (FLC) ratio(κ/λ) * Disappearance of clonal cells in bone marrow by immunohistochemistry or immunofluorescence CR: Fulfills all of the following criteria * Negative immunofixation of serum and urine M-protein * \<5% plasma cells in bone marrow * Disappearance of any soft tissue plasmacytoma VGPR: Fulfills at least one of the following criteria * Serum and urine M-protein detectable by immunofixation but not electrophoresis * ≥90% reduction in serum M-protein and 24-hour M-protein excretion amount in urine \<0.1 g/24 hour PR: Fulfills the following criteria * ≥50% reduction in serum M-protein, and ≥90% reduction in urine M-protein, urine M-protein excretion amount is reduced to \< 0.2 g/24hours

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: up to around 44 weeks
• Results posted on: 2015-02-06

Participant Flow

Participant milestones

Measure	SyB L-0501 SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
Overall Study STARTED	17
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	SyB L-0501 SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
Overall Study Physician Decision	1
Overall Study Progression of the primary disease	3

Baseline Characteristics

Study of SyB L-0501 to Treat Relapsed/Refractory Multiple Myeloma

Baseline characteristics by cohort

Measure	SyB L-0501 n=17 Participants SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
Age, Continuous	63.5 Years STANDARD_DEVIATION 9.8 • n=93 Participants
Age, Customized 20-29 years	0 participants n=93 Participants
Age, Customized 30-39 years	0 participants n=93 Participants
Age, Customized 40-49 years	2 participants n=93 Participants
Age, Customized 50-59 years	3 participants n=93 Participants
Age, Customized 60-69 years	7 participants n=93 Participants
Age, Customized 70-79 years	5 participants n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	12 Participants n=93 Participants
Subtype of myeloma Immunoglobulin G	10 participants n=93 Participants
Subtype of myeloma Immunoglobulin A	6 participants n=93 Participants
Subtype of myeloma Immunoglobulin D	0 participants n=93 Participants
Subtype of myeloma Bence Jones type	8 participants n=93 Participants
Subtype of myeloma κ	13 participants n=93 Participants
Subtype of myeloma λ	4 participants n=93 Participants
Prior therapy Absent	0 participants n=93 Participants
Prior therapy Present	17 participants n=93 Participants
Prior therapy Proteasome inhibitor	17 participants n=93 Participants
Prior therapy IMIDs	16 participants n=93 Participants
Prior therapy Alkylating agent	17 participants n=93 Participants
Prior therapy Other	11 participants n=93 Participants
Performance status 0	7 participants n=93 Participants
Performance status 1	8 participants n=93 Participants
Performance status 2	2 participants n=93 Participants
Clinical disease stage (International Staging System) I	3 participants n=93 Participants
Clinical disease stage (International Staging System) II	11 participants n=93 Participants
Clinical disease stage (International Staging System) III	3 participants n=93 Participants
Medical history Absent	10 participants n=93 Participants
Medical history Present	7 participants n=93 Participants
Accompanying symptoms of the primary disease Absent	1 participants n=93 Participants
Accompanying symptoms of the primary disease Present	16 participants n=93 Participants
Complication Absent	0 participants n=93 Participants
Complication Present	17 participants n=93 Participants
Serum β2 microglobulin	4.03 mg/L STANDARD_DEVIATION 1.59 • n=93 Participants
Height	159.05 cm STANDARD_DEVIATION 9.95 • n=93 Participants
Body weight	56.86 kg STANDARD_DEVIATION 10.06 • n=93 Participants
Body surface area	1.576 m^2 STANDARD_DEVIATION 0.181 • n=93 Participants

PRIMARY outcome

Timeframe: up to around 44 weeks

The criteria for sCR, CR, VGPR, and PR based on IMWG are shown below.

sCR: Fulfills CR criteria as well as all of the following conditions

• Normal free light chain (FLC) ratio(κ/λ)
• Disappearance of clonal cells in bone marrow by immunohistochemistry or immunofluorescence

CR: Fulfills all of the following criteria

• Negative immunofixation of serum and urine M-protein
• <5% plasma cells in bone marrow
• Disappearance of any soft tissue plasmacytoma

VGPR: Fulfills at least one of the following criteria

• Serum and urine M-protein detectable by immunofixation but not electrophoresis
• ≥90% reduction in serum M-protein and 24-hour M-protein excretion amount in urine <0.1 g/24 hour

PR: Fulfills the following criteria

• ≥50% reduction in serum M-protein, and ≥90% reduction in urine M-protein, urine M-protein excretion amount is reduced to < 0.2 g/24hours

Outcome measures

Measure

SyB L-0501 n=17 Participants SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.

Response Rate [Stringent CR (sCR)+Complete Response (CR)+Very Good PR (VGPR)+Partial Response (PR)]Based on International Myeloma Working Group (IMWG) Criteria

0 percentage of paticipants Interval 0.0 to 19.5

SECONDARY outcome

Timeframe: up to around 44 weeks

Outcome measures

Measure

SyB L-0501 n=17 Participants SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.

Response Rate (sCR+CR) Based on IMWG Criteria

0 percentage of paticipants Interval 0.0 to 19.5

SECONDARY outcome

Timeframe: up to around 44 weeks

The criteria for CR based on the Blade are shown below.

CR requires all of the followings:

1. Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks

2. <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy

3. No increase in size or number of lytic bone lesions

4. Disappearance of soft tissue plasmacytomas

Outcome measures

Measure

SyB L-0501 n=17 Participants SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.

Complete Response (CR) Based on the Blade Criteria

0 percentage of paticipants Interval 0.0 to 19.5

SECONDARY outcome

Timeframe: up to around 44 weeks

The criteria for PR based on the Blade are shown below.

PR requires 1. or all of the others:

1. Some, but not all, of the criteria for CR are fulfilled

2. ≥50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks

3. Reduction in 24 h urinary light chain excretion either by ≥90% or to <200 mg, maintained for a minimum of 6 weeks

4. For patients with non-secretory myeloma only, ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy

5. ≥50% reduction in the size of soft tissue plasmacytomas

6. No increase in size or number of lytic bone lesions

Outcome measures

Measure

SyB L-0501 n=17 Participants SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.

Response Rate (CR+PR) Based on the Blade Criteria

0 percentage of paticipants Interval 0.0 to 19.5

SECONDARY outcome

Timeframe: up to around 44 weeks

Using the registration date as the start date, PFS with relapse/recurrence or progression, and death regardless of the cause as events are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and the 95% confidence interval are to be calculated.

Outcome measures

Measure

SyB L-0501 n=17 Participants SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.

Progression-Free Survival (PFS)

92.0 Days Interval 33.0 to 243.0

SECONDARY outcome

Timeframe: up to around 44 weeks

Using the registration date as the start date, TTF with relapse/recurrence or progression, death regardless of the cause, and early discontinuation of treatment as events are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.

Outcome measures

Measure

SyB L-0501 n=17 Participants SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.

Time to Treatment Failure (TTF)

71.0 Days Interval 33.0 to 243.0

SECONDARY outcome

Timeframe: up to around 44 weeks

From initial response (PR or higher), DOR with relapse/recurrence or progression, and death, regardless of cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.

Outcome measures

Measure

SyB L-0501 n=17 Participants SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.

Duration of Response (DOR)

NA Days Because there was no subject judged as "PR" or higher in this study.

SECONDARY outcome

Timeframe: up to around 44 weeks

Using the registration date as the start date, OS with death, regardless of the cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.

Outcome measures

Measure

SyB L-0501 n=17 Participants SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.

Overall Survival (OS)

243.0 Days Interval 185.0 to The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment.

SECONDARY outcome

Timeframe: up to around 44 weeks

All adverse events occurring during the administration of the investigational product are to be examined for safety by cross tabulation lists and tables of incidence from the viewpoint of relationship with the drug, disease severity and medicine treated group.

Outcome measures

Measure	SyB L-0501 n=17 Participants SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
Adverse Events Any adverse event	17 participants
Adverse Events Adverse drug reaction	17 participants
Adverse Events SAE	4 participants
Adverse Events Death	0 participants
Adverse Events Discontinuation due to adverse events	1 participants

SECONDARY outcome

Timeframe: up to around 44 weeks

Abnormalities 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=17 Participants SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values CD4 lymphocytes decreased	13 participants
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values Electrocardiogram QT corrected interval prolonged	1 participants
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values Investigations - Other, sodium decreased	2 participants
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values Investigations - Other, potassium decreased	1 participants
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values Investigations - Other, calcium increased	1 participants
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values Investigations - Other, Haemoglobin decreased	2 participants
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values Lymphocyte count decreased	16 participants
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values Neutrophil count decreased	11 participants
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values Platelet count decreased	2 participants
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values Weight increased	1 participants
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values White blood cell decreased	12 participants

SECONDARY outcome

Timeframe: up to around 44 weeks

Abnormalities 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=17 Participants SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
Number of Abnormalities (Grade ≥3) in Laboratory Test Values CD4 lymphocytes decreased	14 Events
Number of Abnormalities (Grade ≥3) in Laboratory Test Values Electrocardiogram QT corrected interval prolonged	1 Events
Number of Abnormalities (Grade ≥3) in Laboratory Test Values Investigations - Other, sodium decreased	2 Events
Number of Abnormalities (Grade ≥3) in Laboratory Test Values Investigations - Other, potassium decreased	2 Events
Number of Abnormalities (Grade ≥3) in Laboratory Test Values Investigations - Other, calcium increased	1 Events
Number of Abnormalities (Grade ≥3) in Laboratory Test Values Investigations - Other, Haemoglobin decreased	2 Events
Number of Abnormalities (Grade ≥3) in Laboratory Test Values Lymphocyte count decreased	33 Events
Number of Abnormalities (Grade ≥3) in Laboratory Test Values Neutrophil count decreased	15 Events
Number of Abnormalities (Grade ≥3) in Laboratory Test Values Platelet count decreased	3 Events
Number of Abnormalities (Grade ≥3) in Laboratory Test Values Weight increased	1 Events
Number of Abnormalities (Grade ≥3) in Laboratory Test Values White blood cell decreased	17 Events

Adverse Events

SyB L-0501

Serious events: 4 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	SyB L-0501 n=17 participants at risk SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	5.9% 1/17 • up to around 44 weeks
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 1/17 • up to around 44 weeks
Infections and infestations Pneumonia	5.9% 1/17 • up to around 44 weeks
Gastrointestinal disorders Constipation	5.9% 1/17 • up to around 44 weeks

Other adverse events

Measure	SyB L-0501 n=17 participants at risk SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
Blood and lymphatic system disorders Anaemia	41.2% 7/17 • up to around 44 weeks
Eye disorders Conjunctivitis	5.9% 1/17 • up to around 44 weeks
Eye disorders Dry eye	5.9% 1/17 • up to around 44 weeks
Gastrointestinal disorders Abdominal pain	5.9% 1/17 • up to around 44 weeks
Gastrointestinal disorders Constipation	29.4% 5/17 • up to around 44 weeks
Gastrointestinal disorders Dental caries	5.9% 1/17 • up to around 44 weeks
Gastrointestinal disorders Diarrhoea	17.6% 3/17 • up to around 44 weeks
Gastrointestinal disorders Haemorrhoids	5.9% 1/17 • up to around 44 weeks
Gastrointestinal disorders Nausea	47.1% 8/17 • up to around 44 weeks
Gastrointestinal disorders Proctalgia	5.9% 1/17 • up to around 44 weeks
Gastrointestinal disorders Stomatitis	5.9% 1/17 • up to around 44 weeks
Gastrointestinal disorders Vomiting	11.8% 2/17 • up to around 44 weeks
Gastrointestinal disorders Dyschezia	5.9% 1/17 • up to around 44 weeks
General disorders Asthenia	5.9% 1/17 • up to around 44 weeks
General disorders Chest pain	5.9% 1/17 • up to around 44 weeks
General disorders Gait disturbance	5.9% 1/17 • up to around 44 weeks
General disorders Generalised oedema	11.8% 2/17 • up to around 44 weeks
General disorders Injection site reaction	23.5% 4/17 • up to around 44 weeks
General disorders Malaise	23.5% 4/17 • up to around 44 weeks
General disorders Oedema peripheral	23.5% 4/17 • up to around 44 weeks
General disorders Pyrexia	17.6% 3/17 • up to around 44 weeks
General disorders Injection site vasculitis	5.9% 1/17 • up to around 44 weeks
Hepatobiliary disorders Hepatic function abnormal	5.9% 1/17 • up to around 44 weeks
Infections and infestations Bronchopneumonia	5.9% 1/17 • up to around 44 weeks
Infections and infestations Nasopharyngitis	11.8% 2/17 • up to around 44 weeks
Infections and infestations Periodontitis	5.9% 1/17 • up to around 44 weeks
Infections and infestations Pharyngitis	5.9% 1/17 • up to around 44 weeks
Infections and infestations Pneumonia	5.9% 1/17 • up to around 44 weeks
Injury, poisoning and procedural complications Fall	5.9% 1/17 • up to around 44 weeks
Injury, poisoning and procedural complications Fracture	5.9% 1/17 • up to around 44 weeks
Injury, poisoning and procedural complications Spinal compression fracture	5.9% 1/17 • up to around 44 weeks
Investigations Alanine aminotransferase increased	23.5% 4/17 • up to around 44 weeks
Investigations Aspartate aminotransferase increased	29.4% 5/17 • up to around 44 weeks
Investigations Blood albumin decreased	11.8% 2/17 • up to around 44 weeks
Investigations Blood calcium increased	11.8% 2/17 • up to around 44 weeks
Investigations Blood chloride decreased	11.8% 2/17 • up to around 44 weeks
Investigations Blood creatinine increased	17.6% 3/17 • up to around 44 weeks
Investigations Blood lactate dehydrogenase increased	11.8% 2/17 • up to around 44 weeks
Investigations Blood potassium decreased	11.8% 2/17 • up to around 44 weeks
Investigations Blood pressure decreased	5.9% 1/17 • up to around 44 weeks
Investigations Blood sodium decreased	17.6% 3/17 • up to around 44 weeks
Investigations Blood urea increased	11.8% 2/17 • up to around 44 weeks
Investigations Blood uric acid decreased	11.8% 2/17 • up to around 44 weeks
Investigations Blood uric acid increased	5.9% 1/17 • up to around 44 weeks
Investigations C-reactive protein increased	29.4% 5/17 • up to around 44 weeks
Investigations CD4 lymphocytes decreased	76.5% 13/17 • up to around 44 weeks
Investigations Electrocardiogram QT prolonged	5.9% 1/17 • up to around 44 weeks
Investigations Gamma-glutamyltransferase increased	11.8% 2/17 • up to around 44 weeks
Investigations Blood urine present	23.5% 4/17 • up to around 44 weeks
Investigations Haemoglobin decreased	41.2% 7/17 • up to around 44 weeks
Investigations Lymphocyte count decreased	94.1% 16/17 • up to around 44 weeks
Investigations Neutrophil count decreased	94.1% 16/17 • up to around 44 weeks
Investigations Neutrophil count increased	11.8% 2/17 • up to around 44 weeks
Investigations Platelet count decreased	70.6% 12/17 • up to around 44 weeks
Investigations Protein total decreased	5.9% 1/17 • up to around 44 weeks
Investigations Protein total increased	5.9% 1/17 • up to around 44 weeks
Investigations Red blood cell count decreased	29.4% 5/17 • up to around 44 weeks
Investigations Weight decreased	35.3% 6/17 • up to around 44 weeks
Investigations Weight increased	5.9% 1/17 • up to around 44 weeks
Investigations White blood cell count decreased	100.0% 17/17 • up to around 44 weeks
Investigations White blood cell count increased	11.8% 2/17 • up to around 44 weeks
Investigations Protein urine present	11.8% 2/17 • up to around 44 weeks
Investigations Blood alkaline phosphatase increased	5.9% 1/17 • up to around 44 weeks
Investigations Urine output decreased	5.9% 1/17 • up to around 44 weeks
Metabolism and nutrition disorders Hyperkalaemia	17.6% 3/17 • up to around 44 weeks
Metabolism and nutrition disorders Hyperuricaemia	5.9% 1/17 • up to around 44 weeks
Metabolism and nutrition disorders Hypoalbuminaemia	11.8% 2/17 • up to around 44 weeks
Metabolism and nutrition disorders Hypochloraemia	5.9% 1/17 • up to around 44 weeks
Metabolism and nutrition disorders Hypokalaemia	5.9% 1/17 • up to around 44 weeks
Metabolism and nutrition disorders Hypophosphataemia	5.9% 1/17 • up to around 44 weeks
Metabolism and nutrition disorders Decreased appetite	23.5% 4/17 • up to around 44 weeks
Musculoskeletal and connective tissue disorders Arthralgia	11.8% 2/17 • up to around 44 weeks
Metabolism and nutrition disorders Hyponatraemia	17.6% 3/17 • up to around 44 weeks
Musculoskeletal and connective tissue disorders Back pain	29.4% 5/17 • up to around 44 weeks
Musculoskeletal and connective tissue disorders Bone pain	11.8% 2/17 • up to around 44 weeks
Musculoskeletal and connective tissue disorders Muscle haemorrhage	5.9% 1/17 • up to around 44 weeks
Musculoskeletal and connective tissue disorders Musculoskeletal pain	11.8% 2/17 • up to around 44 weeks
Musculoskeletal and connective tissue disorders Myalgia	5.9% 1/17 • up to around 44 weeks
Musculoskeletal and connective tissue disorders Neck pain	5.9% 1/17 • up to around 44 weeks
Nervous system disorders Dysgeusia	5.9% 1/17 • up to around 44 weeks
Nervous system disorders Headache	11.8% 2/17 • up to around 44 weeks
Nervous system disorders Neuropathy peripheral	5.9% 1/17 • up to around 44 weeks
Nervous system disorders Somnolence	5.9% 1/17 • up to around 44 weeks
Psychiatric disorders Delirium	5.9% 1/17 • up to around 44 weeks
Psychiatric disorders Insomnia	17.6% 3/17 • up to around 44 weeks
Renal and urinary disorders Renal failure	5.9% 1/17 • up to around 44 weeks
Renal and urinary disorders Renal impairment	11.8% 2/17 • up to around 44 weeks
Respiratory, thoracic and mediastinal disorders Hiccups	11.8% 2/17 • up to around 44 weeks
Respiratory, thoracic and mediastinal disorders Hypoxia	5.9% 1/17 • up to around 44 weeks
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	11.8% 2/17 • up to around 44 weeks
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	5.9% 1/17 • up to around 44 weeks
Skin and subcutaneous tissue disorders Alopecia	5.9% 1/17 • up to around 44 weeks
Skin and subcutaneous tissue disorders Decubitus ulcer	5.9% 1/17 • up to around 44 weeks
Skin and subcutaneous tissue disorders Dermatitis contact	5.9% 1/17 • up to around 44 weeks
Skin and subcutaneous tissue disorders Pruritus	23.5% 4/17 • up to around 44 weeks
Skin and subcutaneous tissue disorders Rash	11.8% 2/17 • up to around 44 weeks
Surgical and medical procedures Tooth extraction	5.9% 1/17 • up to around 44 weeks
Vascular disorders Hypertension	11.8% 2/17 • up to around 44 weeks
Renal and urinary disorders Dysuria	5.9% 1/17 • up to around 44 weeks

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