Trial Outcomes & Findings for Study of PAC-1 and Entrectinib for Patients With Metastatic Uveal Melanoma (NCT NCT04589832)
NCT ID: NCT04589832
Last Updated: 2023-11-22
Results Overview
The MTD of PAC-1 in combination with entrectinib is the highest tested dose of PAC-1 combined with entrectinib with DLT rate of less than 33% in first cycle of therapy (i.e., ≤1 out of 6 subjects with DLT)
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
28 days
Results posted on
2023-11-22
Participant Flow
Participant milestones
| Measure |
Study Treatment Arm
Phase 1b will determine the MTD of PAC-1 in combination with entrectinib. Study treatment will include: PAC-1 will be taken orally on Days 1-21 and Entrectinib will be taken orally on Days 1-28 of each 28-day cycle. Treatment will continue until disease progression (based on RECIST 1.1 criteria), unacceptable toxicity, subject withdrawal of informed consent, or subject death either from progression of disease, the therapy itself, or from other causes.
PAC-1: Pharmacokinetic (PK) and pharmacodynamic (PD) assay for PAC-1 will be performed during Days 1 and 21 of Cycle 1. PAC-1 will be given on Day 1 of Cycle 1, withheld on Day 2 and Day 3 of Cycle 1 then reinitiated on Day 4 of Cycle 1 to continue for 21 days of the 28-day cycle. For each successive cycle, PAC-1 therapy will be initiated on Day 1 and continue for 21 days of the 28-day cycle.
Entrectinib: Pharmacokinetic and pharmacodynamic assay for entrectinib will be performed during Days 3 and 21 of Cycle 1. Entrectinib therapy will be withheld on Day 1 and Day 2 of Cycle 1, initiated on Day 3 of Cycle 1 and continue for the remainder of the 28 day cycle. For each successive cycle, entrectinib will be intiated on Day 1 and continue for 28 days of the 28-day cycle.
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|---|---|
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Overall Study
STARTED
|
6
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Overall Study
COMPLETED
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6
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of PAC-1 and Entrectinib for Patients With Metastatic Uveal Melanoma
Baseline characteristics by cohort
| Measure |
Study Treatment Arm
n=6 Participants
Phase 1b will determine the MTD of PAC-1 in combination with entrectinib. Study treatment will include: PAC-1 will be taken orally on Days 1-21 and Entrectinib will be taken orally on Days 1-28 of each 28-day cycle. Treatment will continue until disease progression (based on RECIST 1.1 criteria), unacceptable toxicity, subject withdrawal of informed consent, or subject death either from progression of disease, the therapy itself, or from other causes.
PAC-1: Pharmacokinetic (PK) and pharmacodynamic (PD) assay for PAC-1 will be performed during Days 1 and 21 of Cycle 1. PAC-1 will be given on Day 1 of Cycle 1, withheld on Day 2 and Day 3 of Cycle 1 then reinitiated on Day 4 of Cycle 1 to continue for 21 days of the 28-day cycle. For each successive cycle, PAC-1 therapy will be initiated on Day 1 and continue for 21 days of the 28-day cycle.
Entrectinib: Pharmacokinetic and pharmacodynamic assay for entrectinib will be performed during Days 3 and 21 of Cycle 1. Entrectinib therapy will be withheld on Day 1 and Day 2 of Cycle 1, initiated on Day 3 of Cycle 1 and continue for the remainder of the 28 day cycle. For each successive cycle, entrectinib will be intiated on Day 1 and continue for 28 days of the 28-day cycle.
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|---|---|
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Age, Continuous
|
63.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
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4 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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6 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 28 daysPopulation: Because of episodes of neutropenia in two patients and grade 2 dizziness and ataxia in two patients after the first cycle of therapy, dose interruptions and reductions to a lower dose level (Dose level -1: 625 mg PAC-1 + 400 mg Entrectinib) were required. The new dose level (Dose level -1) was not further explored due to lack of funding. Therefore, the study did not determine an MTD.
The MTD of PAC-1 in combination with entrectinib is the highest tested dose of PAC-1 combined with entrectinib with DLT rate of less than 33% in first cycle of therapy (i.e., ≤1 out of 6 subjects with DLT)
Outcome measures
| Measure |
Study Treatment Arm
n=6 Participants
Phase 1b will determine the MTD of PAC-1 in combination with entrectinib. Study treatment will include: PAC-1 will be taken orally on Days 1-21 and Entrectinib will be taken orally on Days 1-28 of each 28-day cycle. Treatment will continue until disease progression (based on RECIST 1.1 criteria), unacceptable toxicity, subject withdrawal of informed consent, or subject death either from progression of disease, the therapy itself, or from other causes.
PAC-1: Pharmacokinetic (PK) and pharmacodynamic (PD) assay for PAC-1 will be performed during Days 1 and 21 of Cycle 1. PAC-1 will be given on Day 1 of Cycle 1, withheld on Day 2 and Day 3 of Cycle 1 then reinitiated on Day 4 of Cycle 1 to continue for 21 days of the 28-day cycle. For each successive cycle, PAC-1 therapy will be initiated on Day 1 and continue for 21 days of the 28-day cycle.
Entrectinib: Pharmacokinetic and pharmacodynamic assay for entrectinib will be performed during Days 3 and 21 of Cycle 1. Entrectinib therapy will be withheld on Day 1 and Day 2 of Cycle 1, initiated on Day 3 of Cycle 1 and continue for the remainder of the 28 day cycle. For each successive cycle, entrectinib will be intiated on Day 1 and continue for 28 days of the 28-day cycle.
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|---|---|
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Phase 1b: Determine Maximum Tolerated Dose (MTD)
PAC-1(Dose level 1)
|
625 mg
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Phase 1b: Determine Maximum Tolerated Dose (MTD)
Entrectinib(Dose level 1)
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600 mg
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PRIMARY outcome
Timeframe: Time of treatment start until the criteria for disease progression.Population: This study is terminated at phase 1b without reaching MTD due to lack of funding. Therefore, there is no accrual in phase 2.
PFS is defined as proportion of alive subjects with metastatic uveal melanoma at 3 months from treatment initiation with PAC-1 in combination with entrectinib without evidence of radiological disease progression by RECIST 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: AEs will be recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 10 months.Population: This study is terminated at phase 1b due to lack of funding. Therefore, no accrual in phase 2.
The frequency and severity of all treatment related grade 1 and 2 adverse events are reported by CTCAEv5 term and grade.
Outcome measures
| Measure |
Study Treatment Arm
n=6 Participants
Phase 1b will determine the MTD of PAC-1 in combination with entrectinib. Study treatment will include: PAC-1 will be taken orally on Days 1-21 and Entrectinib will be taken orally on Days 1-28 of each 28-day cycle. Treatment will continue until disease progression (based on RECIST 1.1 criteria), unacceptable toxicity, subject withdrawal of informed consent, or subject death either from progression of disease, the therapy itself, or from other causes.
PAC-1: Pharmacokinetic (PK) and pharmacodynamic (PD) assay for PAC-1 will be performed during Days 1 and 21 of Cycle 1. PAC-1 will be given on Day 1 of Cycle 1, withheld on Day 2 and Day 3 of Cycle 1 then reinitiated on Day 4 of Cycle 1 to continue for 21 days of the 28-day cycle. For each successive cycle, PAC-1 therapy will be initiated on Day 1 and continue for 21 days of the 28-day cycle.
Entrectinib: Pharmacokinetic and pharmacodynamic assay for entrectinib will be performed during Days 3 and 21 of Cycle 1. Entrectinib therapy will be withheld on Day 1 and Day 2 of Cycle 1, initiated on Day 3 of Cycle 1 and continue for the remainder of the 28 day cycle. For each successive cycle, entrectinib will be intiated on Day 1 and continue for 28 days of the 28-day cycle.
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|---|---|
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Assess Adverse Events
Dizziness
|
4 Participants
|
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Assess Adverse Events
Dysarthria
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4 Participants
|
|
Assess Adverse Events
Anemia
|
4 Participants
|
|
Assess Adverse Events
Increased creatinine
|
4 Participants
|
|
Assess Adverse Events
Fatigue
|
3 Participants
|
|
Assess Adverse Events
Ataxia
|
2 Participants
|
|
Assess Adverse Events
Dysgeusia
|
2 Participants
|
|
Assess Adverse Events
Neutropenia
|
2 Participants
|
|
Assess Adverse Events
AST elevation
|
2 Participants
|
|
Assess Adverse Events
Face edema
|
2 Participants
|
|
Assess Adverse Events
Constipation
|
2 Participants
|
|
Assess Adverse Events
Skin pain
|
2 Participants
|
|
Assess Adverse Events
ALT elevation
|
1 Participants
|
|
Assess Adverse Events
Flashing lights
|
1 Participants
|
|
Assess Adverse Events
Eye Floaters
|
1 Participants
|
|
Assess Adverse Events
Tinnitus
|
1 Participants
|
|
Assess Adverse Events
Akathisia
|
1 Participants
|
|
Assess Adverse Events
Dyspepsia
|
1 Participants
|
|
Assess Adverse Events
Nausea
|
1 Participants
|
|
Assess Adverse Events
Abdominal pain
|
1 Participants
|
|
Assess Adverse Events
Urinary incontinence
|
1 Participants
|
|
Assess Adverse Events
Urinary hesitancy
|
1 Participants
|
|
Assess Adverse Events
Euphoria
|
1 Participants
|
|
Assess Adverse Events
Memory impairment
|
1 Participants
|
|
Assess Adverse Events
Numbness
|
1 Participants
|
|
Assess Adverse Events
Back pain
|
1 Participants
|
|
Assess Adverse Events
Edema limbs
|
1 Participants
|
|
Assess Adverse Events
Sensory neuropathy
|
1 Participants
|
|
Assess Adverse Events
Macular rash
|
1 Participants
|
|
Assess Adverse Events
Thrombocytopenia
|
1 Participants
|
|
Assess Adverse Events
Presyncope
|
1 Participants
|
|
Assess Adverse Events
Mental fog
|
1 Participants
|
SECONDARY outcome
Timeframe: Start of treatment until disease progression/recurrencePopulation: This study is terminated at phase 1b without reaching MTD due to lack of funding. Therefore, no accrual in phase 2 and no result available for ORR.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. ORR is defined as the proportion of all subjects with confirmed PR or CR according to RECIST 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from complete or partial response (whichever status is recorded first) until the date that recurrent or progressive disease.Population: This study is terminated at phase 1b due to lack of funding. Therefore, no accrual in phase 2 and no result for DoR.
DoR is defined as the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the date that recurrent or progressive disease is objectively documented
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to a maximum of 15 monthsPopulation: This study is terminated at phase 1b due to lack of funding. Therefore, no accrual in phase 2.
OS is defined as the time from treatment initiation with PAC-1 in combination with entrectinib until death as a result of any cause
Outcome measures
| Measure |
Study Treatment Arm
n=6 Participants
Phase 1b will determine the MTD of PAC-1 in combination with entrectinib. Study treatment will include: PAC-1 will be taken orally on Days 1-21 and Entrectinib will be taken orally on Days 1-28 of each 28-day cycle. Treatment will continue until disease progression (based on RECIST 1.1 criteria), unacceptable toxicity, subject withdrawal of informed consent, or subject death either from progression of disease, the therapy itself, or from other causes.
PAC-1: Pharmacokinetic (PK) and pharmacodynamic (PD) assay for PAC-1 will be performed during Days 1 and 21 of Cycle 1. PAC-1 will be given on Day 1 of Cycle 1, withheld on Day 2 and Day 3 of Cycle 1 then reinitiated on Day 4 of Cycle 1 to continue for 21 days of the 28-day cycle. For each successive cycle, PAC-1 therapy will be initiated on Day 1 and continue for 21 days of the 28-day cycle.
Entrectinib: Pharmacokinetic and pharmacodynamic assay for entrectinib will be performed during Days 3 and 21 of Cycle 1. Entrectinib therapy will be withheld on Day 1 and Day 2 of Cycle 1, initiated on Day 3 of Cycle 1 and continue for the remainder of the 28 day cycle. For each successive cycle, entrectinib will be intiated on Day 1 and continue for 28 days of the 28-day cycle.
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|---|---|
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Overall Survival (OS)
Phase 1b: OS
|
11.49 Months
Interval 8.1 to 14.75
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Adverse Events
Study Treatment Arm
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Study Treatment Arm
n=6 participants at risk
Phase 1b will determine the MTD of PAC-1 in combination with entrectinib. Study treatment will include: PAC-1 will be taken orally on Days 1-21 and Entrectinib will be taken orally on Days 1-28 of each 28-day cycle. Treatment will continue until disease progression (based on RECIST 1.1 criteria), unacceptable toxicity, subject withdrawal of informed consent, or subject death either from progression of disease, the therapy itself, or from other causes.
PAC-1: Pharmacokinetic (PK) and pharmacodynamic (PD) assay for PAC-1 will be performed during Days 1 and 21 of Cycle 1. PAC-1 will be given on Day 1 of Cycle 1, withheld on Day 2 and Day 3 of Cycle 1 then reinitiated on Day 4 of Cycle 1 to continue for 21 days of the 28-day cycle. For each successive cycle, PAC-1 therapy will be initiated on Day 1 and continue for 21 days of the 28-day cycle.
Entrectinib: Pharmacokinetic and pharmacodynamic assay for entrectinib will be performed during Days 3 and 21 of Cycle 1. Entrectinib therapy will be withheld on Day 1 and Day 2 of Cycle 1, initiated on Day 3 of Cycle 1 and continue for the remainder of the 28 day cycle. For each successive cycle, entrectinib will be intiated on Day 1 and continue for 28 days of the 28-day cycle.
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|---|---|
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Skin and subcutaneous tissue disorders
URTICARIA
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
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Other adverse events
| Measure |
Study Treatment Arm
n=6 participants at risk
Phase 1b will determine the MTD of PAC-1 in combination with entrectinib. Study treatment will include: PAC-1 will be taken orally on Days 1-21 and Entrectinib will be taken orally on Days 1-28 of each 28-day cycle. Treatment will continue until disease progression (based on RECIST 1.1 criteria), unacceptable toxicity, subject withdrawal of informed consent, or subject death either from progression of disease, the therapy itself, or from other causes.
PAC-1: Pharmacokinetic (PK) and pharmacodynamic (PD) assay for PAC-1 will be performed during Days 1 and 21 of Cycle 1. PAC-1 will be given on Day 1 of Cycle 1, withheld on Day 2 and Day 3 of Cycle 1 then reinitiated on Day 4 of Cycle 1 to continue for 21 days of the 28-day cycle. For each successive cycle, PAC-1 therapy will be initiated on Day 1 and continue for 21 days of the 28-day cycle.
Entrectinib: Pharmacokinetic and pharmacodynamic assay for entrectinib will be performed during Days 3 and 21 of Cycle 1. Entrectinib therapy will be withheld on Day 1 and Day 2 of Cycle 1, initiated on Day 3 of Cycle 1 and continue for the remainder of the 28 day cycle. For each successive cycle, entrectinib will be intiated on Day 1 and continue for 28 days of the 28-day cycle.
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|---|---|
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Gastrointestinal disorders
ABDOMINAL PAIN
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Nervous system disorders
AKATHISIA
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Blood and lymphatic system disorders
ANEMIA
|
66.7%
4/6 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
16.7%
1/6 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
66.7%
4/6 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Nervous system disorders
ATAXIA
|
33.3%
2/6 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Investigations
CHOLESTEROL HIGH
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Gastrointestinal disorders
CONSTIPATION
|
50.0%
3/6 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Investigations
CREATININE INCREASED
|
66.7%
4/6 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Psychiatric disorders
DEPRESSION
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Gastrointestinal disorders
DIARRHEA
|
33.3%
2/6 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Nervous system disorders
DIZZINESS
|
66.7%
4/6 • Number of events 13 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Nervous system disorders
DYSARTHRIA
|
83.3%
5/6 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Nervous system disorders
DYSGEUSIA
|
50.0%
3/6 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
General disorders
EDEMA FACE
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
General disorders
EDEMA LIMBS
|
33.3%
2/6 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Endocrine disorders
ENDOCRINE DISORDERS - OTHER, SPECIFY
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Psychiatric disorders
EUPHORIA
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Eye disorders
EYE DISORDERS - OTHER, SPECIFY
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Injury, poisoning and procedural complications
FALL
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
General disorders
FATIGUE
|
66.7%
4/6 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
General disorders
FEVER
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Eye disorders
FLASHING LIGHTS
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Eye disorders
FLOATERS
|
16.7%
1/6 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
General disorders
GAIT DISTURBANCE
|
16.7%
1/6 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Vascular disorders
HYPERTENSION
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
16.7%
1/6 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Vascular disorders
HYPOTENSION
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Gastrointestinal disorders
NAUSEA
|
33.3%
2/6 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY
|
33.3%
2/6 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
33.3%
2/6 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
33.3%
2/6 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Investigations
PLATELET COUNT DECREASED
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Nervous system disorders
PRESYNCOPE
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Renal and urinary disorders
RENAL AND URINARY DISORDERS - OTHER, SPECIFY
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
|
16.7%
1/6 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNEA
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Ear and labyrinth disorders
TINNITUS
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
16.7%
1/6 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Gastrointestinal disorders
VOMITING
|
16.7%
1/6 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Investigations
WEIGHT GAIN
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
16.7%
1/6 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place