Trial Outcomes & Findings for A Study of Vadastuximab Talirine Given Prior to or After Allogeneic Hematopoietic Stem Cell Transplant in AML Patients (NCT NCT02614560)
NCT ID: NCT02614560
Last Updated: 2019-01-09
Results Overview
AE: Adverse events; TEAE: Treatment-emergent adverse event. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event. An AE is considered serious if it was fatal, life threatening, required hospitalization, was disabling/incapacitating, resulted in a birth defect or congenital anomally, or was otherwise considered to be medically significant.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Approximately 1 year
Results posted on
2019-01-09
Participant Flow
Participant milestones
| Measure |
Pre-allo (Before Stem Cell Transplant)
Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)
Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)
Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant
vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
|
Post-allo (After Stem Cell Transplant)
Post-allo vadastuximab talirine
vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
|
Overall Study
COMPLETED
|
0
|
6
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Pre-allo (Before Stem Cell Transplant)
Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)
Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)
Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant
vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
|
Post-allo (After Stem Cell Transplant)
Post-allo vadastuximab talirine
vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle
|
|---|---|---|
|
Overall Study
Death
|
6
|
2
|
Baseline Characteristics
A Study of Vadastuximab Talirine Given Prior to or After Allogeneic Hematopoietic Stem Cell Transplant in AML Patients
Baseline characteristics by cohort
| Measure |
Pre-allo (Before Stem Cell Transplant)
n=6 Participants
Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)
Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)
Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant
vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
|
Post-allo (After Stem Cell Transplant)
n=8 Participants
Post-allo vadastuximab talirine
vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.0 years
n=5 Participants
|
58.0 years
n=7 Participants
|
58.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0: Normal activity
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 1: Symptoms but ambulatory
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 1 yearAE: Adverse events; TEAE: Treatment-emergent adverse event. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event. An AE is considered serious if it was fatal, life threatening, required hospitalization, was disabling/incapacitating, resulted in a birth defect or congenital anomally, or was otherwise considered to be medically significant.
Outcome measures
| Measure |
Pre-allo (Before Stem Cell Transplant)
n=6 Participants
Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)
Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)
Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant
vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
|
Post-allo (After Stem Cell Transplant)
n=8 Participants
Post-allo vadastuximab talirine
vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle
|
|---|---|---|
|
Incidence of Adverse Events
AEs Leading to Treatment Discontinuation
|
0 Participants
|
1 Participants
|
|
Incidence of Adverse Events
Grade 3 or Higher TEAEs
|
6 Participants
|
6 Participants
|
|
Incidence of Adverse Events
TEAEs
|
6 Participants
|
8 Participants
|
|
Incidence of Adverse Events
AEs Related to Vadatuximab Talirine
|
6 Participants
|
7 Participants
|
|
Incidence of Adverse Events
Serious AEs
|
5 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Approximately 1 yearNumber (count) of participants that experienced a Grade 3 or higher laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.
Outcome measures
| Measure |
Pre-allo (Before Stem Cell Transplant)
n=6 Participants
Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)
Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)
Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant
vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
|
Post-allo (After Stem Cell Transplant)
n=8 Participants
Post-allo vadastuximab talirine
vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle
|
|---|---|---|
|
Incidence of Laboratory Abnormalities
Aspartate aminotransferase (iu/l)
|
1 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities
Sodium (meq/l)
|
0 Participants
|
1 Participants
|
|
Incidence of Laboratory Abnormalities
Any chemistry test
|
4 Participants
|
3 Participants
|
|
Incidence of Laboratory Abnormalities
Amylase (iu/l)
|
3 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities
Alanine aminotransferase (iu/l)
|
1 Participants
|
1 Participants
|
|
Incidence of Laboratory Abnormalities
Total bilirubin (mg/dl)
|
3 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities
Uric acid (mg/dl)
|
1 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities
Lipase (iu/l)
|
0 Participants
|
1 Participants
|
|
Incidence of Laboratory Abnormalities
Any hematology test
|
6 Participants
|
5 Participants
|
|
Incidence of Laboratory Abnormalities
Hemoglobin (g/dl)
|
3 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities
Lymphocytes (x10^3/ul)
|
6 Participants
|
1 Participants
|
|
Incidence of Laboratory Abnormalities
Neutrophils (x10^3/ul)
|
6 Participants
|
4 Participants
|
|
Incidence of Laboratory Abnormalities
Platlets (x10^3/ul)
|
6 Participants
|
4 Participants
|
|
Incidence of Laboratory Abnormalities
White blood cell count (x10^3/ul)
|
6 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All treated patients set
1-year survival rate estimated using Kaplan-Meier methods The start date for overall survival is the day of alloSCT.
Outcome measures
| Measure |
Pre-allo (Before Stem Cell Transplant)
n=6 Participants
Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)
Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)
Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant
vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
|
Post-allo (After Stem Cell Transplant)
n=8 Participants
Post-allo vadastuximab talirine
vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle
|
|---|---|---|
|
1-year Survival Rate
|
0 percentage of participants
Insufficient participants with events to calculate confidence interval.
|
75 percentage of participants
Interval 31.0 to 93.0
|
PRIMARY outcome
Timeframe: 30 daysPopulation: All treated patients set, pre-allo cohort
Rate of MRD (minimal residual disease) negativity at Day -1 (1 day prior to transplant) and Day 30 post-transplant (Part A only)
Outcome measures
| Measure |
Pre-allo (Before Stem Cell Transplant)
n=6 Participants
Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)
Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)
Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant
vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
|
Post-allo (After Stem Cell Transplant)
Post-allo vadastuximab talirine
vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle
|
|---|---|---|
|
Rate of MRD Negativity
Day -1 Rate of MRD Negativity
|
NA Percentage of participants
Insufficient number of participants with events to estimate rate
|
—
|
|
Rate of MRD Negativity
Day 30 Rate of MRD Negativity
|
75 Percentage of participants
Interval 19.4 to 99.4
|
—
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: Part A (pre-alloSCT) only
Percentage of patients who achieved a best response of CRi (complete remission with incomplete blood count recovery) or CR (complete remission)
Outcome measures
| Measure |
Pre-allo (Before Stem Cell Transplant)
n=6 Participants
Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)
Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)
Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant
vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
|
Post-allo (After Stem Cell Transplant)
Post-allo vadastuximab talirine
vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle
|
|---|---|---|
|
Best Response of CR or CRi
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: Part A (pre-alloSCT) only
Defined as the time from the start of the first documented complete response (CR) or complete remission with incomplete blood count recovery (CRi) to the documentation of relapse or death due to any cause.
Outcome measures
| Measure |
Pre-allo (Before Stem Cell Transplant)
n=6 Participants
Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)
Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)
Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant
vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
|
Post-allo (After Stem Cell Transplant)
Post-allo vadastuximab talirine
vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle
|
|---|---|---|
|
Duration of Response
|
6.57 weeks
Interval 3.0 to 9.0
|
—
|
SECONDARY outcome
Timeframe: Approximately 96 weeksDefined as the time from the day of alloSCT to the date of death due to any cause.
Outcome measures
| Measure |
Pre-allo (Before Stem Cell Transplant)
n=6 Participants
Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)
Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)
Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant
vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
|
Post-allo (After Stem Cell Transplant)
n=8 Participants
Post-allo vadastuximab talirine
vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle
|
|---|---|---|
|
Overall Survival
|
11.07 weeks
Interval 7.43 to 15.71
|
NA weeks
Interval 31.14 to
\<50% of participants experienced an event
|
Adverse Events
Pre-allo (Before Stem Cell Transplant)
Serious events: 5 serious events
Other events: 6 other events
Deaths: 6 deaths
Post-allo (After Stem Cell Transplant)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Pre-allo (Before Stem Cell Transplant)
n=6 participants at risk
Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)
Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)
Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant
vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
|
Post-allo (After Stem Cell Transplant)
n=8 participants at risk
Post-allo vadastuximab talirine
vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Immune system disorders
Graft versus host disease in lung
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Device related infection
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Parotitis
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Sepsis
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
2/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Vascular disorders
Venoocclusive disease
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
Other adverse events
| Measure |
Pre-allo (Before Stem Cell Transplant)
n=6 participants at risk
Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)
Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)
Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant
vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
|
Post-allo (After Stem Cell Transplant)
n=8 participants at risk
Post-allo vadastuximab talirine
vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle
|
|---|---|---|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
83.3%
5/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
25.0%
2/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
50.0%
3/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
4/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
25.0%
2/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Chills
|
33.3%
2/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Face oedema
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
50.0%
4/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Malaise
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
50.0%
3/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Oedema peripheral
|
83.3%
5/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Immune system disorders
Graft versus host disease in eye
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Candida infection
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Device related infection
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Enterococcal infection
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Pneumonia fungal
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Systemic candida
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Respirovirus test positive
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Staphylococcus test positive
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Weight increased
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
3/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
50.0%
3/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
25.0%
2/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
25.0%
2/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
2/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
25.0%
2/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
37.5%
3/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
62.5%
5/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
2/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
62.5%
5/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Cardiac disorders
Cardiomegaly
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Eye disorders
Conjunctival haemorrhage
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Eye disorders
Eye discharge
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Eye disorders
Eye pruritus
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
25.0%
2/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
3/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Enterocolitis
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
37.5%
3/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Nervous system disorders
Seizure
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Nervous system disorders
Tremor
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Psychiatric disorders
Agitation
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Psychiatric disorders
Hallucination
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
83.3%
5/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Renal and urinary disorders
Bladder hypertrophy
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Renal and urinary disorders
Urinary tract pain
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Reproductive system and breast disorders
Menorrhagia
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
66.7%
4/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
50.0%
3/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery wall hypertrophy
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pain
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
25.0%
2/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
2/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Vascular disorders
Embolism
|
0.00%
0/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
12.5%
1/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/8 • Up to approximately 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60