Trial Outcomes & Findings for Safety and Pharmacokinetics Study of SyB L-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS) (NCT NCT01700335)
NCT ID: NCT01700335
Last Updated: 2022-11-21
Results Overview
A DLT was defined as adverse events for which a causal relationship with the investigational drug could not be ruled out and which met the following criteria that occurred by the final observation in Cycle 2. DLTs were also to be assessed in the Efficacy and Safety Assessment Committee. Criteria: 1. Grade 3 or higher non-hematologic toxicity. However, nausea, vomiting, diarrhea, pyrexia, stomatitis, and esophagitis/dysphagia are excluded (Grade 3 nausea, vomiting, diarrhea, and pyrexia that cannot be controlled with antiemetic, antidiarrheal, or antifebrile agents are regarded as DLTs) 2. Grade 3 or higher stomatitis, esophagitis, and dysphagia that persist for \>= 4 days
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
Up to 60 weeks
Results posted on
2022-11-21
Participant Flow
Participant milestones
| Measure |
SyB L-1101 1200 mg/Day Group
Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles.
|
SyB L-1101 1800 mg/Day Group
Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Pharmacokinetics Study of SyB L-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS)
Baseline characteristics by cohort
| Measure |
All Participants
n=9 Participants
All participants who received at least 1 dose of SyB L-1101 either at 1200 mg/day or 1800 mg/day intravenously.
|
|---|---|
|
Age, Customized
60-69 years
|
4 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
4 participants
n=5 Participants
|
|
Age, Customized
80- years
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 60 weeksA DLT was defined as adverse events for which a causal relationship with the investigational drug could not be ruled out and which met the following criteria that occurred by the final observation in Cycle 2. DLTs were also to be assessed in the Efficacy and Safety Assessment Committee. Criteria: 1. Grade 3 or higher non-hematologic toxicity. However, nausea, vomiting, diarrhea, pyrexia, stomatitis, and esophagitis/dysphagia are excluded (Grade 3 nausea, vomiting, diarrhea, and pyrexia that cannot be controlled with antiemetic, antidiarrheal, or antifebrile agents are regarded as DLTs) 2. Grade 3 or higher stomatitis, esophagitis, and dysphagia that persist for \>= 4 days
Outcome measures
| Measure |
SyB L-1101 1200 mg/Day Group
n=3 Participants
Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles.
|
SyB L-1101 1800 mg/Day Group
n=6 Participants
Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles.
|
|---|---|---|
|
Number of Participants Who Experienced Dose-limiting Toxicities (DLTs)
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Up to 60 weeksDefinition Complete remission (CR) Bone marrow: \<= 5% myeloblasts; normal maturation of all cell lines Peripheral blood: Hemoglobin (Hgb) \>= 11 g/dL, Platelets \>= 100×10\^9/L, Neutrophils \>= 1.0×10\^9/L, Blasts 0% Partial remission (PR) Same as CR criteria except bone marrow blasts decreased by \>= 50% over pretreatment but still \> 5% Marrow CR Bone marrow: \<= 5% myeloblasts and decrease by \>= 50% over pretreatment Peripheral blood: will be noted in addition to marrow CR Stable disease Failure to achieve at least PR, but no evidence of progression for \> 8 wks Disease progression Patients with: Less than 5% blasts: \>= 50% increase in blasts to \> 5% blasts 5%-10% blasts: \>= 50% increase to \> 10% blasts 10%-20% blasts: \>= 50% increase to \> 20% blasts 20%-30% blasts: \>= 50% increase to \> 30% blasts Any of the following: At least 50% decrement from maximum remission/response in granulocytes or platelets Reduction in Hgb by \>= 2 g/dL Transfusion dependence
Outcome measures
| Measure |
SyB L-1101 1200 mg/Day Group
n=3 Participants
Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles.
|
SyB L-1101 1800 mg/Day Group
n=6 Participants
Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles.
|
|---|---|---|
|
Hematologic Remission Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 4 Weeks)
Marrow CR
|
0 participants
|
0 participants
|
|
Hematologic Remission Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 4 Weeks)
Stable disease (SD)
|
0 participants
|
2 participants
|
|
Hematologic Remission Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 4 Weeks)
Treatment failure
|
0 participants
|
0 participants
|
|
Hematologic Remission Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 4 Weeks)
Remission rate
|
0 participants
|
0 participants
|
|
Hematologic Remission Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 4 Weeks)
CR
|
0 participants
|
0 participants
|
|
Hematologic Remission Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 4 Weeks)
PR
|
0 participants
|
0 participants
|
|
Hematologic Remission Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 4 Weeks)
Disease progression
|
3 participants
|
2 participants
|
|
Hematologic Remission Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 4 Weeks)
Not assessable
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Up to 60 weeksDefinition Hematologic Improvement Erythrocyte (HI-E): Hgb increase by \>= 1.5 g/dL Relevant reduction of units of red blood cell (RBC) transfusions by an absolute number of at least 4 RBC transfusions/8 week compared with the pretreatment transfusion number in the previous 8 week. Only RBC transfusions given for a Hgb of \<= 9.0 g/dL pretreatment will count in the RBC transfusion response evaluation Hematologic Improvement Platelet (HI-P): Absolute increase of \>= 30×10\^9/L for patients starting with \> 20×10\^9/L platelets Increase from \< 20×10\^9/L to \> 20×10\^9/L and by at least 100% Hematologic Improvement Neutrophil (HI-N): At least 100% increase and an absolute increase \> 0.5×10\^9/L Progressive disease / Relapse: At least 1 of the following: At least 50% decrement from maximum response levels in granulocytes or platelets Reduction in Hgb by \>= 1.5 g/dL Transfusion dependence
Outcome measures
| Measure |
SyB L-1101 1200 mg/Day Group
n=3 Participants
Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles.
|
SyB L-1101 1800 mg/Day Group
n=6 Participants
Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles.
|
|---|---|---|
|
Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 8 Weeks)
Hematologic improvement rate
|
0 participants
|
0 participants
|
|
Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 8 Weeks)
HI-E
|
0 participants
|
0 participants
|
|
Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 8 Weeks)
HI-P
|
0 participants
|
0 participants
|
|
Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 8 Weeks)
HI-N
|
0 participants
|
0 participants
|
|
Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 8 Weeks)
Progressive disease
|
1 participants
|
2 participants
|
|
Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 8 Weeks)
Relapse
|
0 participants
|
0 participants
|
|
Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 8 Weeks)
Not assessable
|
2 participants
|
4 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 16 weeksMTD was investigated with an index of DLT
Outcome measures
| Measure |
SyB L-1101 1200 mg/Day Group
n=9 Participants
Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles.
|
SyB L-1101 1800 mg/Day Group
Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles.
|
|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
NA participants
MTD was not reached
|
—
|
Adverse Events
SyB L-1101 1200 mg/Day Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SyB L-1101 1800 mg/Day Group
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SyB L-1101 1200 mg/Day Group
n=3 participants at risk
Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles.
|
SyB L-1101 1800 mg/Day Group
n=6 participants at risk
Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles.
|
|---|---|---|
|
Infections and infestations
Meningitis
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
Other adverse events
| Measure |
SyB L-1101 1200 mg/Day Group
n=3 participants at risk
Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles.
|
SyB L-1101 1800 mg/Day Group
n=6 participants at risk
Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles.
|
|---|---|---|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
0.00%
0/6 • Up to 16 weeks
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Number of events 4 • Up to 16 weeks
|
0.00%
0/6 • Up to 16 weeks
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Gastrointestinal disorders
Chronic gastritis
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
0.00%
0/6 • Up to 16 weeks
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
0.00%
0/6 • Up to 16 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 3 • Up to 16 weeks
|
|
Gastrointestinal disorders
Gastritis
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
0.00%
0/6 • Up to 16 weeks
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Gastrointestinal disorders
Tongue haematoma
|
33.3%
1/3 • Number of events 4 • Up to 16 weeks
|
0.00%
0/6 • Up to 16 weeks
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
0.00%
0/6 • Up to 16 weeks
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 2 • Up to 16 weeks
|
|
General disorders
Malaise
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 3 • Up to 16 weeks
|
|
General disorders
Oedema
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
33.3%
2/6 • Number of events 4 • Up to 16 weeks
|
|
General disorders
Thirst
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
General disorders
Catheter site pain
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
General disorders
Catheter site pruritus
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
General disorders
Catheter site haematoma
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
General disorders
Infusion site extravasation
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
0.00%
0/6 • Up to 16 weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 2 • Up to 16 weeks
|
|
Infections and infestations
Muscle abscess
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
16.7%
1/6 • Number of events 2 • Up to 16 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
16.7%
1/6 • Number of events 2 • Up to 16 weeks
|
|
Investigations
Blood albumin decreased
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
0.00%
0/6 • Up to 16 weeks
|
|
Investigations
Blood chloride decreased
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Investigations
Blood calcium decreased
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Investigations
Blood uric acid decreased
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Investigations
C-reactive protein increased
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
16.7%
1/6 • Number of events 3 • Up to 16 weeks
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/3 • Up to 16 weeks
|
33.3%
2/6 • Number of events 2 • Up to 16 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Investigations
Haemoglobin decreased
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
16.7%
1/6 • Number of events 2 • Up to 16 weeks
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • Number of events 6 • Up to 16 weeks
|
33.3%
2/6 • Number of events 2 • Up to 16 weeks
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Number of events 6 • Up to 16 weeks
|
33.3%
2/6 • Number of events 3 • Up to 16 weeks
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Number of events 3 • Up to 16 weeks
|
66.7%
4/6 • Number of events 6 • Up to 16 weeks
|
|
Investigations
Protein total decreased
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
16.7%
1/6 • Number of events 2 • Up to 16 weeks
|
|
Investigations
Red blood cell count decreased
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
16.7%
1/6 • Number of events 3 • Up to 16 weeks
|
|
Investigations
White blood cell count decreased
|
66.7%
2/3 • Number of events 3 • Up to 16 weeks
|
50.0%
3/6 • Number of events 9 • Up to 16 weeks
|
|
Investigations
Neutrophil percentage decreased
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Investigations
Lymphocyte percentage increased
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Investigations
Protein urine present
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 2 • Up to 16 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 2 • Up to 16 weeks
|
|
Investigations
Hepatitis B DNA assay positive
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 2 • Up to 16 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 2 • Up to 16 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to 16 weeks
|
33.3%
2/6 • Number of events 3 • Up to 16 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Up to 16 weeks
|
33.3%
2/6 • Number of events 2 • Up to 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
0.00%
0/6 • Up to 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
0.00%
0/6 • Up to 16 weeks
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Up to 16 weeks
|
50.0%
3/6 • Number of events 6 • Up to 16 weeks
|
|
Psychiatric disorders
Insomnia
|
66.7%
2/3 • Number of events 2 • Up to 16 weeks
|
0.00%
0/6 • Up to 16 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 3 • Up to 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
0.00%
0/6 • Up to 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
0.00%
0/6 • Up to 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Up to 16 weeks
|
33.3%
2/6 • Number of events 4 • Up to 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
0.00%
0/6 • Up to 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
66.7%
2/3 • Number of events 2 • Up to 16 weeks
|
0.00%
0/6 • Up to 16 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
|
Skin and subcutaneous tissue disorders
Purpura
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks
|
0.00%
0/6 • Up to 16 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Up to 16 weeks
|
16.7%
1/6 • Number of events 1 • Up to 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place