Trial Outcomes & Findings for A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma (NCT NCT03947255)
NCT ID: NCT03947255
Last Updated: 2023-10-13
Results Overview
Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on BICR
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Up to 18.3 months
Results posted on
2023-10-13
Participant Flow
Participant milestones
| Measure |
Classic Hodgkin Lymphoma
Participants with classic Hodgkin lymphoma
|
PTCL
Participants with peripheral T cell lymphoma
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Classic Hodgkin Lymphoma
Participants with classic Hodgkin lymphoma
|
PTCL
Participants with peripheral T cell lymphoma
|
|---|---|---|
|
Overall Study
Study Closure by Sponsor
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Death
|
0
|
2
|
Baseline Characteristics
A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Classic Hodgkin Lymphoma
n=5 Participants
Participants with classic Hodgkin lymphoma
|
PTCL
n=6 Participants
Participants with peripheral T cell lymphoma
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
31 Years
n=5 Participants
|
63 Years
n=7 Participants
|
50 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 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
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 1
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 18.3 monthsPopulation: The full analysis set includes participants who received at least one dose of study treatment.
Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on BICR
Outcome measures
| Measure |
Classic Hodgkin Lymphoma
n=5 Participants
Participants with classic Hodgkin lymphoma
|
PTCL
n=6 Participants
Participants with peripheral T cell lymphoma
|
|---|---|---|
|
Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: The full analysis set includes participants who received at least one dose of study treatment.
An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment.
Outcome measures
| Measure |
Classic Hodgkin Lymphoma
n=5 Participants
Participants with classic Hodgkin lymphoma
|
PTCL
n=6 Participants
Participants with peripheral T cell lymphoma
|
|---|---|---|
|
Number of Participants With Adverse Events
Any TEAE
|
5 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events
Treatment-related TEAE
|
4 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events
Any Treatment-Emergent SAE
|
0 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events
Discontinuation of treatment due to TEAE
|
1 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events
Discontinuation of treatment due to treatment-related TEAE
|
1 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events
TEAE leading to death
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 36 monthsLaboratory data was summarized by the worst post-baseline grade, by NCI CTCAE v5.0 or higher for each parameter.
Outcome measures
| Measure |
Classic Hodgkin Lymphoma
n=5 Participants
Participants with classic Hodgkin lymphoma
|
PTCL
n=6 Participants
Participants with peripheral T cell lymphoma
|
|---|---|---|
|
Number of Participants With Laboratory Abnormalities
Hemoglobin Low, Grade 1-2
|
3 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities
Hemoglobin Low, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Hemoglobin Low, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Leukocytes Low, Grade 1-2
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities
Leukocytes Low, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Leukocytes Low, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Lymphocytes Low, Grade 1-2
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Lymphocytes Low, Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Lymphocytes Low, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Neutrophils Low, Grade 1-2
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities
Neutrophils Low, Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Neutrophils Low, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Platelets Low, Grade 1-2
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities
Platelets Low, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Platelets Low, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Alanine Aminotransferase High, Grade 1-2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Alanine Aminotransferase High, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Alanine Aminotransferase High, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Albumin Low, Grade 1-2
|
0 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities
Albumin Low, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Albumin Low, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Alkaline Phosphatase High, Grade 1-2
|
1 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities
Alkaline Phosphatase High, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Alkaline Phosphatase High, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Aspartate Aminotransferase High, Grade 1-2
|
3 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities
Aspartate Aminotransferase High, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Aspartate Aminotransferase High, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Bilirubin High, Grade 1-2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Bilirubin High, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Bilirubin High, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Calcium Corrected for Albumin Low, Grade 1-2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Calcium Corrected for Albumin Low, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Calcium Corrected for Albumin Low, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Creatinine High, Grade 1-2
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Creatinine High, Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Creatinine High, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Lactate Dehydrogenase High, Grade 1-2
|
3 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Abnormalities
Lactate Dehydrogenase High, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Lactate Dehydrogenase High, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Potassium Low, Grade 1-2
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities
Potassium Low, Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Potassium Low, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Sodium High, Grade 1-2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Sodium High, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Sodium High, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Sodium Low, Grade 1-2
|
3 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Sodium Low, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Sodium Low, Grade 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 17.1 monthsPopulation: The full analysis set includes participants who received at least one dose of study treatment. This is a subset analysis of participants with complete response or partial response.
Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first.
Outcome measures
| Measure |
Classic Hodgkin Lymphoma
n=2 Participants
Participants with classic Hodgkin lymphoma
|
PTCL
n=5 Participants
Participants with peripheral T cell lymphoma
|
|---|---|---|
|
Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria
|
NA months
Not enough events to calculate Median or Lower and Upper Limits.
|
NA months
Interval 2.9 to
Not enough events to calculate Median or Upper Limit.
|
SECONDARY outcome
Timeframe: up to 18.3 monthsPopulation: The full analysis set includes participants who received at least one dose of study treatment.
PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first.
Outcome measures
| Measure |
Classic Hodgkin Lymphoma
n=5 Participants
Participants with classic Hodgkin lymphoma
|
PTCL
n=6 Participants
Participants with peripheral T cell lymphoma
|
|---|---|---|
|
Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria
|
NA Months
Interval 1.3 to
Not enough events to calculate Median or Upper Limit.
|
NA Months
Interval 1.1 to
Not enough events to calculate Median or Upper Limit.
|
SECONDARY outcome
Timeframe: Up to 35.8 monthsPopulation: The full analysis set includes participants who received at least one dose of study treatment.
OS is defined as the time from date of enrollment to date of death due to any cause.
Outcome measures
| Measure |
Classic Hodgkin Lymphoma
n=5 Participants
Participants with classic Hodgkin lymphoma
|
PTCL
n=6 Participants
Participants with peripheral T cell lymphoma
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Not enough events to calculate Median or Lower and Upper Limits.
|
NA Months
Interval 1.1 to
Not enough events to calculate Median or Upper Limit.
|
SECONDARY outcome
Timeframe: Up to 18.3 monthsPopulation: The full analysis set includes participants who received at least one dose of study treatment.
CR rate is defined as the percentage of participants with CR according to the modified Lugano Criteria for Response Assessment (Cheson 2014)
Outcome measures
| Measure |
Classic Hodgkin Lymphoma
n=5 Participants
Participants with classic Hodgkin lymphoma
|
PTCL
n=6 Participants
Participants with peripheral T cell lymphoma
|
|---|---|---|
|
Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria
|
20.0 Percentage of Participants
Interval 0.5 to 71.6
|
66.7 Percentage of Participants
Interval 22.3 to 95.7
|
SECONDARY outcome
Timeframe: Up to 18.3 monthsPopulation: The full analysis set includes participants who received at least one dose of study treatment.
Objective Response Rate (ORR) is defined as the percentage of participants with CR or PR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on investigator assessment
Outcome measures
| Measure |
Classic Hodgkin Lymphoma
n=5 Participants
Participants with classic Hodgkin lymphoma
|
PTCL
n=6 Participants
Participants with peripheral T cell lymphoma
|
|---|---|---|
|
ORR Per Investigator Assessment According to Modified Lugano Response Criteria
|
60.0 Percentage of Participants
Interval 14.7 to 94.7
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
SECONDARY outcome
Timeframe: Up to 17.1 monthsPopulation: The full analysis set includes participants who received at least one dose of study treatment. This is a subset analysis of participants with complete response or partial response.
Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first.
Outcome measures
| Measure |
Classic Hodgkin Lymphoma
n=3 Participants
Participants with classic Hodgkin lymphoma
|
PTCL
n=5 Participants
Participants with peripheral T cell lymphoma
|
|---|---|---|
|
DOR Per Investigator Assessment According to Modified Lugano Response Criteria
|
NA Months
Interval 5.1 to
Not enough events to calculate Median or Upper Limit.
|
NA Months
Interval 7.2 to
Not enough events to calculate Median or Upper Limit.
|
SECONDARY outcome
Timeframe: Up to 18.3 monthsPopulation: The full analysis set includes participants who received at least one dose of study treatment.
PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first.
Outcome measures
| Measure |
Classic Hodgkin Lymphoma
n=5 Participants
Participants with classic Hodgkin lymphoma
|
PTCL
n=6 Participants
Participants with peripheral T cell lymphoma
|
|---|---|---|
|
Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria
|
6.5 Months
Interval 3.2 to
Not enough events to calculate Upper Limit.
|
NA Months
Interval 1.1 to
Not enough events to calculate Median or Upper Limit.
|
SECONDARY outcome
Timeframe: Up to 18.3 monthsPopulation: The full analysis set includes participants who received at least one dose of study treatment.
CR rate is defined as the percentage of participants with CR according to the Modified Lugano Criteria for Response Assessment (Cheson 2014).
Outcome measures
| Measure |
Classic Hodgkin Lymphoma
n=5 Participants
Participants with classic Hodgkin lymphoma
|
PTCL
n=6 Participants
Participants with peripheral T cell lymphoma
|
|---|---|---|
|
Rate of Complete Response Per Investigator Assessment According to Modified Lugano Response Criteria
|
40.0 Percentage of Participants
Interval 5.3 to 85.3
|
66.7 Percentage of Participants
Interval 22.3 to 95.7
|
SECONDARY outcome
Timeframe: Up to 18.3 monthsPopulation: The full analysis set includes participants who received at least one dose of study treatment.
ORR is defined as the percentage of participants with CR or PR, assessed according to Lugano Criteria for Response Assessment (Cheson 2014)
Outcome measures
| Measure |
Classic Hodgkin Lymphoma
n=5 Participants
Participants with classic Hodgkin lymphoma
|
PTCL
n=6 Participants
Participants with peripheral T cell lymphoma
|
|---|---|---|
|
ORR Per BICR According to Lugano Response Criteria
|
60.0 Percentage of Participants
Interval 14.7 to 94.7
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
Adverse Events
Classic Hodgkin Lymphoma
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PTCL
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Classic Hodgkin Lymphoma
n=5 participants at risk
Participants with classic Hodgkin lymphoma
|
PTCL
n=6 participants at risk
Participants with peripheral T cell lymphoma
|
|---|---|---|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
Other adverse events
| Measure |
Classic Hodgkin Lymphoma
n=5 participants at risk
Participants with classic Hodgkin lymphoma
|
PTCL
n=6 participants at risk
Participants with peripheral T cell lymphoma
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
33.3%
2/6 • Number of events 6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
General disorders
Chills
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
General disorders
Fatigue
|
20.0%
1/5 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
33.3%
2/6 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
General disorders
Gait disturbance
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
General disorders
Malaise
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Infections and infestations
Localised infection
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Infections and infestations
Oral infection
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Investigations
Amylase increased
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Investigations
Blood creatinine increased
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Investigations
Weight decreased
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.0%
1/5 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
0.00%
0/6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
0.00%
0/6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Nervous system disorders
Neuropathy peripheral
|
20.0%
1/5 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
0.00%
0/6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Nervous system disorders
Paraesthesia
|
20.0%
1/5 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
0.00%
0/6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
1/5 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
66.7%
4/6 • Number of events 6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
1/5 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
0.00%
0/6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
16.7%
1/6 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place