Trial Outcomes & Findings for Selinexor in Initial or Refractory and/or Relapsed Richter's Transformation (NCT NCT02138786)
NCT ID: NCT02138786
Last Updated: 2023-01-26
Results Overview
Overall Response Rate (ORR) is defined as the point estimate of the percentage of patients who have complete response (CR) or partial response (PR). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. CR was defined as disappearance of all evidence of disease, and PR was defined as ≥ 50% regression of measurable disease and no new sites.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.
Results posted on
2023-01-26
Participant Flow
This multicenter study was conducted at 30 clinical investigative sites in the United States and Europe. Of the 30 investigative sites, 15 sites enrolled a total of 27 patients in the study. * Date first patient enrolled: 14 November 2014 * Date last patient completed: 31 August 2016
Of the 35 total patients screened, 8 patients were screen-failures. Of the 27 enrolled patients, one patient withdrew from the study prior to receiving treatment. Therefore, a total of 26 patients comprised the Safety population.
Participant milestones
| Measure |
Selinexor 60 mg/m² (8 Doses/Cycle)
60 mg/m² dose twice weekly for weeks 1-4
|
Selinexor 60 mg (6 Doses/Cycle)
60 mg oral dose twice weekly for weeks 1-3
|
Selinexor 60 mg (8 Doses/Cycle)
60 mg oral dose twice weekly for weeks 1-4
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
15
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
15
|
8
|
Reasons for withdrawal
| Measure |
Selinexor 60 mg/m² (8 Doses/Cycle)
60 mg/m² dose twice weekly for weeks 1-4
|
Selinexor 60 mg (6 Doses/Cycle)
60 mg oral dose twice weekly for weeks 1-3
|
Selinexor 60 mg (8 Doses/Cycle)
60 mg oral dose twice weekly for weeks 1-4
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
1
|
|
Overall Study
Death
|
1
|
7
|
2
|
|
Overall Study
Disease Progression
|
1
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
|
Overall Study
Patient's Wish
|
0
|
2
|
0
|
|
Overall Study
Sponsor Terminated Study
|
0
|
1
|
1
|
|
Overall Study
Non-Compliance
|
0
|
0
|
1
|
Baseline Characteristics
Selinexor in Initial or Refractory and/or Relapsed Richter's Transformation
Baseline characteristics by cohort
| Measure |
Selinexor 60 mg/m² (8 Doses/Cycle)
n=3 Participants
60 mg/m² oral dose twice weekly for Weeks 1-4
|
Selinexor 60 mg (6 Doses/Cycle)
n=15 Participants
60 mg oral dose twice weekly for Weeks 1-3
|
Selinexor 60 mg (8 Doses/Cycle)
n=8 Participants
60 mg oral dose twice weekly for Weeks 1-4
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.0 years
n=99 Participants
|
68.0 years
n=107 Participants
|
69.0 years
n=206 Participants
|
68.0 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
ECOG score
Score=0
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
ECOG score
Score=1
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
ECOG score
Score=2
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
ECOG score
Missing
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Weight
|
56.5 kg
n=99 Participants
|
76.5 kg
n=107 Participants
|
73.05 kg
n=206 Participants
|
74.40 kg
n=7 Participants
|
PRIMARY outcome
Timeframe: Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.Population: Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
Overall Response Rate (ORR) is defined as the point estimate of the percentage of patients who have complete response (CR) or partial response (PR). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. CR was defined as disappearance of all evidence of disease, and PR was defined as ≥ 50% regression of measurable disease and no new sites.
Outcome measures
| Measure |
Selinexor
n=25 Participants
All dosing groups
|
|---|---|
|
Percentage of Participants With Overall Response (Overall Response Rate)
|
4 Percentage of participants
Interval 0.1 to 20.4
|
PRIMARY outcome
Timeframe: Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.Population: Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
Number of patients who achieved CR (complete disappearance of all detectable evidence of disease). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.
Outcome measures
| Measure |
Selinexor
n=25 Participants
All dosing groups
|
|---|---|
|
Number of Participants With Complete Response (CR)
|
0 Participants
|
PRIMARY outcome
Timeframe: Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.Population: Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
Number of patients whose best overall response to study treatment was PR (≥ 50% regression of measurable disease and no new sites). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.
Outcome measures
| Measure |
Selinexor
n=25 Participants
All dosing groups
|
|---|---|
|
Number of Participants With Partial Response (PR)
|
1 Participants
|
PRIMARY outcome
Timeframe: Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.Population: Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
Number of patients whose best overall response to study treatment was SD (failure to attain criteria for CR or PR, or to meet criteria for PD). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.
Outcome measures
| Measure |
Selinexor
n=25 Participants
All dosing groups
|
|---|---|
|
Number of Participants With Stable Disease (SD)
|
6 Participants
|
PRIMARY outcome
Timeframe: Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.Population: Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
Number of patients whose best overall response to study treatment was PD (any new lesion or increase by ≥ 50% of previously involved sites from nadir). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.
Outcome measures
| Measure |
Selinexor
n=25 Participants
All dosing groups
|
|---|---|
|
Number of Participants With Progressive Disease (PD)
|
7 Participants
|
PRIMARY outcome
Timeframe: Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.Population: Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
Number of patients who could not be assessed quantitatively for disease response for any reason.
Outcome measures
| Measure |
Selinexor
n=25 Participants
All dosing groups
|
|---|---|
|
Number of Participants With Not Evaluable (NE) Response
|
11 Participants
|
SECONDARY outcome
Timeframe: Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.Population: Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
Disease Control Rate (DCR) is defined as the percentage of patients who achieved CR, PR, or SD lasting for at least 8 weeks. CR was defined as disappearance of all evidence of disease. PR was defined as ≥ 50% regression of measurable disease and no new sites. SD was defined as failure to attain criteria for CR or PR, or to meet criteria for PD. Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.
Outcome measures
| Measure |
Selinexor
n=25 Participants
All dosing groups
|
|---|---|
|
Percentage of Participants With Disease Control (Disease Control Rate)
|
28.0 Percentage of participants
Interval 12.1 to 49.4
|
SECONDARY outcome
Timeframe: Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.Population: Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
Number of days calculated from date of start of study therapy to date of progression based on IWG criteria, or date of death if progression did not occur. Patients who dropped out prior to study end without evidence of disease progression were censored at the day they were last known to be alive. Patients without documented disease progression or recurrence were censored at the date of last disease assessment. Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. .
Outcome measures
| Measure |
Selinexor
n=25 Participants
All dosing groups
|
|---|---|
|
Duration of Progression Free Survival (PFS)
|
38.0 Days
Interval 22.0 to 86.0
|
Adverse Events
Selinexor 60 mg/m² (8 Doses/Cycle)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Selinexor 60 mg (6 Doses/Cycle)
Serious events: 9 serious events
Other events: 15 other events
Deaths: 8 deaths
Selinexor 60 mg (8 Doses/Cycle)
Serious events: 5 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Selinexor 60 mg/m² (8 Doses/Cycle)
n=3 participants at risk
60 mg/m² oral dose twice weekly for Weeks 1-4
|
Selinexor 60 mg (6 Doses/Cycle)
n=15 participants at risk
60 mg oral dose twice weekly for Weeks 1-3
|
Selinexor 60 mg (8 Doses/Cycle)
n=8 participants at risk
60 mg oral dose twice weekly for Weeks 1-4
|
|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
25.0%
2/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
General disorders
Asthenia
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
General disorders
Mucosal Inflammation
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Metabolism and nutrition disorders
Food Intolerance
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Vascular disorders
Embolism Arterial
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Investigations
Clostridium Test Positive
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Haemorrhage
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
Other adverse events
| Measure |
Selinexor 60 mg/m² (8 Doses/Cycle)
n=3 participants at risk
60 mg/m² oral dose twice weekly for Weeks 1-4
|
Selinexor 60 mg (6 Doses/Cycle)
n=15 participants at risk
60 mg oral dose twice weekly for Weeks 1-3
|
Selinexor 60 mg (8 Doses/Cycle)
n=8 participants at risk
60 mg oral dose twice weekly for Weeks 1-4
|
|---|---|---|---|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Gastrointestinal disorders
Tongue Coated
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
40.0%
6/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
25.0%
2/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
26.7%
4/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
25.0%
2/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
General disorders
Asthenia
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
26.7%
4/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
25.0%
2/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
33.3%
5/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
General disorders
General Physical Health Deterioration
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
General disorders
Mucosal Inflammation
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
General disorders
Early Satiety
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
General disorders
Facial Pain
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
General disorders
Oedema
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
General disorders
Pain
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
53.3%
8/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
62.5%
5/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
33.3%
5/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
20.0%
3/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
37.5%
3/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Blood and lymphatic system disorders
Leukopenia
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
13.3%
2/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
25.0%
2/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
13.3%
2/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
66.7%
2/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
33.3%
5/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
25.0%
2/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
26.7%
4/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
25.0%
2/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
37.5%
3/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
25.0%
2/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
13.3%
2/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
13.3%
2/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
13.3%
2/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
25.0%
2/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Infections and infestations
Urinary Tract Infection
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Infections and infestations
Oral Infection
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
13.3%
2/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Infections and infestations
Herpes Ophthalmic
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Infections and infestations
Oral Herpes
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
26.7%
4/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
25.0%
2/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
13.3%
2/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
50.0%
4/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
20.0%
3/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Nervous system disorders
Horner's Syndrome
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Nervous system disorders
Hypokinesia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Nervous system disorders
Migraine With Aura
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Nervous system disorders
Nervous System Disorder
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Nervous system disorders
Visual Field Defect
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Vascular disorders
Hypotension
|
66.7%
2/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
25.0%
2/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Vascular disorders
Haematoma
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Vascular disorders
Hot Flush
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Vascular disorders
Pallor
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Vascular disorders
Post Procedural Contusion
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
13.3%
2/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Investigations
Weight Decreased
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
37.5%
3/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Investigations
C-Reactive Protein Increased
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
13.3%
2/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
13.3%
2/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Investigations
Aspartate Aminotransferase Increased
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Investigations
Blood Creatinine Phophokinase Decreased
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Investigations
Blood Creatinine Phosphokinase Increased
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Investigations
Hypophonesis
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Investigations
Protein Total Decreased
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
37.5%
3/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
13.3%
2/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
13.3%
2/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Eye disorders
Eye Irritation
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Eye disorders
Ocular Toxicity
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Injury, poisoning and procedural complications
Skain Abrasion
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
25.0%
2/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Associated Fever
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Ear and labyrinth disorders
Vertigo
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
13.3%
2/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Cardiac disorders
Tachycardia
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Reproductive system and breast disorders
Oedema Genital
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
46.7%
7/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
12.5%
1/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
13.3%
2/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
25.0%
2/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
13.3%
2/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Gastrointestinal disorders
Anal Incontinence
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
13.3%
2/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
13.3%
2/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
6.7%
1/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
0.00%
0/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
53.3%
8/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
37.5%
3/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
33.3%
5/15 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
37.5%
3/8 • Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place