Trial Outcomes & Findings for Everolimus With and Without Temozolomide in Adult Low Grade Glioma (NCT NCT02023905)
NCT ID: NCT02023905
Last Updated: 2022-12-29
Results Overview
Participants will be analyzed based on intention to treat using the Response Assessment in Neuro-Oncology (RANO) criteria for progression. Based on RANO criteria, a responder is defined using both radiographic and clinical criteria. Complete response (CR) or Partial Response (PR) will be first assessed by radiographic changes as determined by an improvement of the bi-dimensional evaluation of the tumor size. In addition, changes in neurologic function and steroid use will be considered. Analyses will be performed after all enrolled participants in arm 1 or arm 2 have completed 33 months on study, or whenever the progression status of all participants has been established, whichever comes first. Kaplan-Meier estimates and the associated 95% confidence intervals (CI) will be calculated for the 33-month PFS separately for the two arms.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Up to 33 Months
Results posted on
2022-12-29
Participant Flow
Participant milestones
| Measure |
Arm 1: Everolimus
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the phosphatidylinositol 3-kinase (PI3K)
/Mechanistic target of rapamycin (mTOR) pathway. If activation is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
Arm 2: Everolimus and Temozolomide
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If activation is not present, patients will be treated with combined everolimus and temozolomide (TMZ). Everolimus will be given at 10 mg daily continuously for up to 24 cycles, and Temozolomide will be dosed initially at 150 mg/m\^2 per day for 5 days out of a 28-day cycle for up to 12 cycles.
|
Arm 3: Everolimus (1p/19q Co-deletion Present)
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If 1p/19q co-deletion is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
2
|
9
|
|
Overall Study
COMPLETED
|
16
|
2
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Everolimus With and Without Temozolomide in Adult Low Grade Glioma
Baseline characteristics by cohort
| Measure |
Arm 1: Everolimus
n=16 Participants
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If activation is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
Arm 2: Everolimus and Temozolomide
n=2 Participants
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If activation is not present, patients will be treated with combined everolimus and temozolomide (TMZ). Everolimus will be given at 10 mg daily continuously for up to 24 cycles, and Temozolomide will be dosed initially at 150 mg/m\^2 per day for 5 days out of a 28-day cycle for up to 12 cycles.
|
Arm 3: Everolimus (1p/19q Co-deletion Present)
n=9 Participants
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If 1p/19q co-deletion is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
20-29 years old
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Customized
30-39 years old
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Customized
40-49 years old
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Customized
50-59 years old
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Customized
60-69 years old
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
27 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 33 MonthsPopulation: One participant in Arm 2 went off treatment after only a few days of beginning therapy but was included in the analysis as part of the ITT population
Participants will be analyzed based on intention to treat using the Response Assessment in Neuro-Oncology (RANO) criteria for progression. Based on RANO criteria, a responder is defined using both radiographic and clinical criteria. Complete response (CR) or Partial Response (PR) will be first assessed by radiographic changes as determined by an improvement of the bi-dimensional evaluation of the tumor size. In addition, changes in neurologic function and steroid use will be considered. Analyses will be performed after all enrolled participants in arm 1 or arm 2 have completed 33 months on study, or whenever the progression status of all participants has been established, whichever comes first. Kaplan-Meier estimates and the associated 95% confidence intervals (CI) will be calculated for the 33-month PFS separately for the two arms.
Outcome measures
| Measure |
Arm 1: Everolimus
n=16 Participants
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If activation is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
Arm 2: Everolimus and Temozolomide
n=2 Participants
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If activation is not present, patients will be treated with combined everolimus and temozolomide (TMZ). Everolimus will be given at 10 mg daily continuously for up to 24 cycles, and Temozolomide will be dosed initially at 150 mg/m\^2 per day for 5 days out of a 28-day cycle for up to 12 cycles.
|
Arm 3: Everolimus (1p/19q Co-deletion Present)
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If 1p/19q co-deletion is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
|---|---|---|---|
|
Progression-Free Survival Rate (PFS) (Arms 1 and 2)
|
31 percentage of participants
Interval 15.1 to 64.6
|
NA percentage of participants
There were insufficient number of events so an estimate and confidence interval could not be calculated.
|
—
|
PRIMARY outcome
Timeframe: Up to 38 MonthsParticipants will be analyzed based on intention to treat using the Response Assessment in Neuro-Oncology (RANO) criteria for progression. Based on RANO criteria, a responder is defined using both radiographic and clinical criteria. Complete response (CR) or Partial Response (PR) will be first assessed by radiographic changes as determined by an improvement of the bi-dimensional evaluation of the tumor size. In addition, changes in neurologic function and steroid use will be considered. Analyses will be performed after all participants enrolled in arm 3 have completed 38 months on study, or whenever the progression status of all participants has been established, whichever comes first. Kaplan-Meier estimates and the associated 95% CIs will be calculated for the 38-month PFS.
Outcome measures
| Measure |
Arm 1: Everolimus
n=9 Participants
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If activation is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
Arm 2: Everolimus and Temozolomide
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If activation is not present, patients will be treated with combined everolimus and temozolomide (TMZ). Everolimus will be given at 10 mg daily continuously for up to 24 cycles, and Temozolomide will be dosed initially at 150 mg/m\^2 per day for 5 days out of a 28-day cycle for up to 12 cycles.
|
Arm 3: Everolimus (1p/19q Co-deletion Present)
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If 1p/19q co-deletion is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
|---|---|---|---|
|
Progression-Free Survival Rate (PFS) (Arm 3)
|
55.5 percentage of participants
Interval 31.0 to 99.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 84 MonthsPopulation: One participant in Arm 2 went off treatment after only a few days of beginning therapy but was included in the analysis as part of the ITT population
Participants will be analyzed based on an intention to treat model. PFS is defined as the time from first objective response to the time of disease progression or death using the Response Assessment in Neuro-Oncology (RANO) criteria to determine progression. If the participant does not have an event of disease progression or recurrence nor has the patient died, the participant's data will be censored at the date of last contact with the patient. Kaplan-Meier estimates and the associated 95% CIs will be calculated.
Outcome measures
| Measure |
Arm 1: Everolimus
n=16 Participants
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If activation is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
Arm 2: Everolimus and Temozolomide
n=2 Participants
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If activation is not present, patients will be treated with combined everolimus and temozolomide (TMZ). Everolimus will be given at 10 mg daily continuously for up to 24 cycles, and Temozolomide will be dosed initially at 150 mg/m\^2 per day for 5 days out of a 28-day cycle for up to 12 cycles.
|
Arm 3: Everolimus (1p/19q Co-deletion Present)
n=9 Participants
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If 1p/19q co-deletion is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
|---|---|---|---|
|
Median Progression Free Survival (PFS)
|
25.8 months
Interval 19.2 to
The upper range of the confidence interval was calculated to be infinity.
|
NA months
There were insufficient number of events so an estimate and confidence interval could not be calculated.
|
43.6 months
Interval 19.4 to
The upper range of the confidence interval was calculated to be infinity.
|
SECONDARY outcome
Timeframe: Up to 84 MonthsPopulation: One participant in Arm 2 went off treatment after only a few days of beginning therapy but was included in the analysis as part of the ITT population
Participants will be analyzed based on an intention to treat model. Overall survival is defined as the first day of treatment until death or study completion, whichever comes first. Kaplan-Meier estimates and the associated 95% CIs will be calculated by treatment arm.
Outcome measures
| Measure |
Arm 1: Everolimus
n=16 Participants
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If activation is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
Arm 2: Everolimus and Temozolomide
n=2 Participants
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If activation is not present, patients will be treated with combined everolimus and temozolomide (TMZ). Everolimus will be given at 10 mg daily continuously for up to 24 cycles, and Temozolomide will be dosed initially at 150 mg/m\^2 per day for 5 days out of a 28-day cycle for up to 12 cycles.
|
Arm 3: Everolimus (1p/19q Co-deletion Present)
n=9 Participants
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If 1p/19q co-deletion is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
|---|---|---|---|
|
Overall Survival Rate (OS)
|
NA percentage of participants
Interval 86.8 to
There were insufficient number of events (2) so an estimate could not be calculated and the upper range of the confidence interval was calculated to be infinity.
|
NA percentage of participants
There were insufficient number of events so an estimate and confidence interval could not be calculated.
|
NA percentage of participants
There were insufficient number of events (0) so an estimate and confidence interval could not be calculated.
|
SECONDARY outcome
Timeframe: Up to 36 MonthsPopulation: One participant in Arm 2 went off treatment after only a few days of beginning therapy but was included in the analysis as part of the ITT population
Overall response rate (ORR) is the percentage of patients who achieved a best response of complete response (CR) or partial response (PR) out of all assigned patients. Based on the best objective status as assessed by the Response Assessment in Neuro-Oncology (RANO) criteria. Using RANO criteria, a responder is defined by radiographic and clinical criteria. Complete response or PR will be first assessed by radiographic changes as determined by an improvement of the bi-dimensional evaluation of the tumor size. In addition, changes in neurologic function and steroid use will be considered. The point estimate and the associated 2-sided 95% CI for the response rate separately for the three arms.
Outcome measures
| Measure |
Arm 1: Everolimus
n=16 Participants
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If activation is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
Arm 2: Everolimus and Temozolomide
n=2 Participants
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If activation is not present, patients will be treated with combined everolimus and temozolomide (TMZ). Everolimus will be given at 10 mg daily continuously for up to 24 cycles, and Temozolomide will be dosed initially at 150 mg/m\^2 per day for 5 days out of a 28-day cycle for up to 12 cycles.
|
Arm 3: Everolimus (1p/19q Co-deletion Present)
n=9 Participants
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If 1p/19q co-deletion is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
|---|---|---|---|
|
Objective Response Rate (ORR)
|
0 percentage of participants
Interval 0.0 to 19.4
|
NA percentage of participants
There were insufficient numbers of participants with events so the ORR and confidence interval could not be calculated
|
11 percentage of participants
Interval 5.7 to 43.5
|
SECONDARY outcome
Timeframe: Up to 36 MonthsPopulation: One participant in Arm 2 went off treatment after only a few days of beginning therapy, so monthly seizure data could not be collected.
To assess the reduction in seizure rate the investigator will compare the seizure rate on study to that experienced one month prior to enrolling in the study. The RANO low grade gliomas (LGG) guideline will be used to assess reduction of seizures, which calls a 50% or more reduction number of monthly seizures an 'improvement'; a 50% or more increase a worsening'; and anything less than 50% in either direction a 'stable seizure rate'.
Outcome measures
| Measure |
Arm 1: Everolimus
n=16 Participants
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If activation is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
Arm 2: Everolimus and Temozolomide
n=1 Participants
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If activation is not present, patients will be treated with combined everolimus and temozolomide (TMZ). Everolimus will be given at 10 mg daily continuously for up to 24 cycles, and Temozolomide will be dosed initially at 150 mg/m\^2 per day for 5 days out of a 28-day cycle for up to 12 cycles.
|
Arm 3: Everolimus (1p/19q Co-deletion Present)
n=9 Participants
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If 1p/19q co-deletion is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
|---|---|---|---|
|
Rate of Reduction in Seizures
|
25 percentage of participants
Interval 8.9 to 53.2
|
NA percentage of participants
Rate and confidence interval could not be calculated for single participant
|
50 percentage of participants
Interval 21.5 to 78.5
|
Adverse Events
Arm 1: Everolimus
Serious events: 1 serious events
Other events: 12 other events
Deaths: 2 deaths
Arm 2: Everolimus and Temozolomide
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 3: Everolimus (1p/19q Co-deletion Present)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Everolimus
n=16 participants at risk
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If activation is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
Arm 2: Everolimus and Temozolomide
n=2 participants at risk
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If activation is not present, patients will be treated with combined everolimus and temozolomide (TMZ). Everolimus will be given at 10 mg daily continuously for up to 24 cycles, and Temozolomide will be dosed initially at 150 mg/m\^2 per day for 5 days out of a 28-day cycle for up to 12 cycles.
|
Arm 3: Everolimus (1p/19q Co-deletion Present)
n=9 participants at risk
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If 1p/19q co-deletion is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Reproductive system and breast disorders
Uterine Pain
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/16 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/16 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
0.00%
0/16 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
Other adverse events
| Measure |
Arm 1: Everolimus
n=16 participants at risk
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If activation is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
Arm 2: Everolimus and Temozolomide
n=2 participants at risk
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If activation is not present, patients will be treated with combined everolimus and temozolomide (TMZ). Everolimus will be given at 10 mg daily continuously for up to 24 cycles, and Temozolomide will be dosed initially at 150 mg/m\^2 per day for 5 days out of a 28-day cycle for up to 12 cycles.
|
Arm 3: Everolimus (1p/19q Co-deletion Present)
n=9 participants at risk
If the tumor is 1p/19q intact, then patients will be further selected by whether or not their tumor demonstrates activation of the PI3K/mTOR pathway. If 1p/19q co-deletion is present, patients will be treated with single-agent everolimus at 10 mg daily continuously for up to 24 cycles.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
37.5%
6/16 • Number of events 19 • Up to 84 months
|
50.0%
1/2 • Number of events 5 • Up to 84 months
|
66.7%
6/9 • Number of events 24 • Up to 84 months
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
4/16 • Number of events 6 • Up to 84 months
|
50.0%
1/2 • Number of events 1 • Up to 84 months
|
33.3%
3/9 • Number of events 5 • Up to 84 months
|
|
Gastrointestinal disorders
Mucositis oral
|
31.2%
5/16 • Number of events 5 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
22.2%
2/9 • Number of events 4 • Up to 84 months
|
|
Gastrointestinal disorders
Nausea
|
25.0%
4/16 • Number of events 6 • Up to 84 months
|
50.0%
1/2 • Number of events 2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
4/16 • Number of events 4 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 2 • Up to 84 months
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
2/16 • Number of events 2 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
22.2%
2/9 • Number of events 2 • Up to 84 months
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
3/16 • Number of events 3 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/16 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/16 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
31.2%
5/16 • Number of events 8 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
55.6%
5/9 • Number of events 6 • Up to 84 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
12.5%
2/16 • Number of events 3 • Up to 84 months
|
50.0%
1/2 • Number of events 1 • Up to 84 months
|
22.2%
2/9 • Number of events 2 • Up to 84 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
2/16 • Number of events 2 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
General disorders
Fatigue
|
43.8%
7/16 • Number of events 7 • Up to 84 months
|
50.0%
1/2 • Number of events 1 • Up to 84 months
|
33.3%
3/9 • Number of events 3 • Up to 84 months
|
|
General disorders
General disorders and administration site conditions - Other
|
12.5%
2/16 • Number of events 2 • Up to 84 months
|
50.0%
1/2 • Number of events 1 • Up to 84 months
|
22.2%
2/9 • Number of events 3 • Up to 84 months
|
|
General disorders
Edema limbs
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
General disorders
Fever
|
6.2%
1/16 • Number of events 2 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
General disorders
Gait disturbance
|
0.00%
0/16 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
General disorders
Irritability
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
General disorders
Pain
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Nervous system disorders
Nervous system disorders - Other
|
18.8%
3/16 • Number of events 4 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
22.2%
2/9 • Number of events 8 • Up to 84 months
|
|
Nervous system disorders
Headache
|
18.8%
3/16 • Number of events 4 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
22.2%
2/9 • Number of events 8 • Up to 84 months
|
|
Nervous system disorders
Tremor
|
12.5%
2/16 • Number of events 2 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Nervous system disorders
Dysphasia
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 2 • Up to 84 months
|
|
Nervous system disorders
Memory Impairment
|
12.5%
2/16 • Number of events 2 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
25.0%
4/16 • Number of events 8 • Up to 84 months
|
50.0%
1/2 • Number of events 5 • Up to 84 months
|
44.4%
4/9 • Number of events 17 • Up to 84 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
18.8%
3/16 • Number of events 3 • Up to 84 months
|
50.0%
1/2 • Number of events 1 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
2/16 • Number of events 2 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Metabolism and nutrition disorders
Anorexia
|
18.8%
3/16 • Number of events 3 • Up to 84 months
|
50.0%
1/2 • Number of events 1 • Up to 84 months
|
22.2%
2/9 • Number of events 2 • Up to 84 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
12.5%
2/16 • Number of events 6 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
22.2%
2/9 • Number of events 3 • Up to 84 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
0.00%
0/16 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Investigations
Weight loss
|
12.5%
2/16 • Number of events 2 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
55.6%
5/9 • Number of events 5 • Up to 84 months
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Investigations
Cholesterol high
|
6.2%
1/16 • Number of events 4 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Investigations
Lipase increased
|
0.00%
0/16 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/16 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 2 • Up to 84 months
|
|
Investigations
Neutrophil count decreased
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
18.8%
3/16 • Number of events 5 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
22.2%
2/9 • Number of events 3 • Up to 84 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.8%
3/16 • Number of events 3 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Investigations
Neck pain
|
12.5%
2/16 • Number of events 2 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Infections and infestations
Infections and infestations - Other
|
18.8%
3/16 • Number of events 4 • Up to 84 months
|
50.0%
1/2 • Number of events 1 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Infections and infestations
Upper respiratory infection
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Infections and infestations
Bronchial infection
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • Up to 84 months
|
50.0%
1/2 • Number of events 1 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
0.00%
0/16 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
33.3%
3/9 • Number of events 3 • Up to 84 months
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Psychiatric disorders
Insomnia
|
12.5%
2/16 • Number of events 2 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Eye disorders
Blurred vision
|
12.5%
2/16 • Number of events 2 • Up to 84 months
|
50.0%
1/2 • Number of events 1 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Eye disorders
Eye disorders - Other
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
6.2%
1/16 • Number of events 2 • Up to 84 months
|
50.0%
1/2 • Number of events 1 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Renal and urinary disorders
Urinary urgency
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
12.5%
2/16 • Number of events 2 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Ear and labyrinth disorders
Tinnitus
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Vascular disorders
Vascular disorders - Other
|
0.00%
0/16 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
22.2%
2/9 • Number of events 2 • Up to 84 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Cardiac disorders
Cardiac disorders - Other
|
0.00%
0/16 • Up to 84 months
|
50.0%
1/2 • Number of events 1 • Up to 84 months
|
11.1%
1/9 • Number of events 1 • Up to 84 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
50.0%
1/2 • Number of events 1 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
1/16 • Number of events 1 • Up to 84 months
|
0.00%
0/2 • Up to 84 months
|
0.00%
0/9 • Up to 84 months
|
Additional Information
Dr. Jennifer Clarke, MD MPH
University of California, San Francisco
Phone: (415) 353-2167
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place