Trial Outcomes & Findings for Imetelstat Sodium in Treating Younger Patients With Recurrent or Refractory Brain Tumors (NCT NCT01836549)
NCT ID: NCT01836549
Last Updated: 2018-07-20
Results Overview
This outcome measure is for the Molecular biology study only. The assessment was done to identify cases with at least 50% reduction in telomerase activity.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Up to 30 days
Results posted on
2018-07-20
Participant Flow
Participant milestones
| Measure |
Molecular Biology Stratum-A
This is the Molecular Biology arm for Medulloblastoma/PNET Patients
|
Molecular Biology Stratum-B
This is the Molecular Biology arm for High-Grade Glioma Patients
|
Molecular Biology Stratum-C
This is the Molecular Biology arm for Ependymoma Patients
|
Stratum-A
This is the Phase-II stratum for Recurrent or Refractory Medulloblastoma/PNET Patients
|
Stratum-B
This is the Phase-II stratum for Recurrent or refractory high-grade glioma patients
|
Stratum-C
This is the Phase-II stratum for Recurrent or refractory ependymoma patients
|
Stratum-D
This is the Phase-II stratum for Recurrent or refractory diffuse intrinsic pontine gliomas (DIPG) patients
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
9
|
18
|
4
|
9
|
|
Overall Study
COMPLETED
|
1
|
1
|
0
|
8
|
18
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Molecular Biology Stratum-A
This is the Molecular Biology arm for Medulloblastoma/PNET Patients
|
Molecular Biology Stratum-B
This is the Molecular Biology arm for High-Grade Glioma Patients
|
Molecular Biology Stratum-C
This is the Molecular Biology arm for Ependymoma Patients
|
Stratum-A
This is the Phase-II stratum for Recurrent or Refractory Medulloblastoma/PNET Patients
|
Stratum-B
This is the Phase-II stratum for Recurrent or refractory high-grade glioma patients
|
Stratum-C
This is the Phase-II stratum for Recurrent or refractory ependymoma patients
|
Stratum-D
This is the Phase-II stratum for Recurrent or refractory diffuse intrinsic pontine gliomas (DIPG) patients
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Did not receive study drug
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Patient declared ineligible
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Patient inevaluable to start therapy
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Imetelstat Sodium in Treating Younger Patients With Recurrent or Refractory Brain Tumors
Baseline characteristics by cohort
| Measure |
Molecular Biology Stratum-A
n=1 Participants
This is the Molecular Biology arm for Medulloblastoma/PNET Patients
|
Molecular Biology Stratum-B
n=1 Participants
This is the Molecular Biology arm for High-Grade Glioma Patients
|
Stratum-A
n=8 Participants
This is the Phase-II stratum for Recurrent or Refractory Medulloblastoma/PNET Patients
|
Stratum-B
n=18 Participants
This is the Phase-II stratum for Recurrent or refractory high-grade glioma patients
|
Stratum-C
n=4 Participants
This is the Phase-II stratum for Recurrent or refractory ependymoma patients
|
Stratum-D
n=8 Participants
This is the Phase-II stratum for Recurrent or refractory diffuse intrinsic pontine gliomas (DIPG) patients
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
10.41 Years
STANDARD_DEVIATION NA • n=39 Participants
|
11.33 Years
STANDARD_DEVIATION NA • n=41 Participants
|
7.94 Years
STANDARD_DEVIATION 4.31 • n=35 Participants
|
11.66 Years
STANDARD_DEVIATION 5.24 • n=31 Participants
|
11.51 Years
STANDARD_DEVIATION 3.84 • n=146 Participants
|
10.45 Years
STANDARD_DEVIATION 2.14 • n=19 Participants
|
10.62 Years
STANDARD_DEVIATION 4.40 • n=147 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
4 Participants
n=19 Participants
|
15 Participants
n=147 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
11 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
4 Participants
n=19 Participants
|
25 Participants
n=147 Participants
|
PRIMARY outcome
Timeframe: Up to 30 daysPopulation: This outcome measure is only for the molecular biology study. Telomerase inhibition was assessed and the inhibition level was compared with the baseline level to identify increased inhibition.
This outcome measure is for the Molecular biology study only. The assessment was done to identify cases with at least 50% reduction in telomerase activity.
Outcome measures
| Measure |
Molecular Biology Study
n=2 Participants
Molecular Biology Phase: Patients will receive one infusion of imetelstat prior to surgery. Surgery will take place 12-24 hours after the infusion of imetelstat. Patients will continue to receive therapy on the same schedule as the Phase II patients starting 14-21 days after surgery.
Phase II: Patients receive imetelstat sodium IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
imetelstat sodium: Given IV
|
Stratum-B
This is the Phase-II stratum for Recurrent or refractory high-grade glioma patients
|
Stratum-C
This is the Phase-II stratum for Recurrent or refractory ependymoma patients
|
Stratum-D
This is the Phase-II stratum for Recurrent or refractory diffuse intrinsic pontine glioma patients
|
|---|---|---|---|---|
|
Numver of Patients With Telomerase-positive Archival Tumors Who Demonstrate at Least 50% Reduction
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: This is the Phase-II study cohort, excluding the molecular study patients.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=50% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR sustained for at least 6 weeks. For each stratum separately exact confidence interval estimates will be provided for the true, unknown rates of objective response. Estimated by cumulative incidence functions.
Outcome measures
| Measure |
Molecular Biology Study
n=8 Participants
Molecular Biology Phase: Patients will receive one infusion of imetelstat prior to surgery. Surgery will take place 12-24 hours after the infusion of imetelstat. Patients will continue to receive therapy on the same schedule as the Phase II patients starting 14-21 days after surgery.
Phase II: Patients receive imetelstat sodium IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
imetelstat sodium: Given IV
|
Stratum-B
n=18 Participants
This is the Phase-II stratum for Recurrent or refractory high-grade glioma patients
|
Stratum-C
n=4 Participants
This is the Phase-II stratum for Recurrent or refractory ependymoma patients
|
Stratum-D
n=8 Participants
This is the Phase-II stratum for Recurrent or refractory diffuse intrinsic pontine glioma patients
|
|---|---|---|---|---|
|
Phase II: Stratum-specific Objective Response (CR+PR) Rate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 30 daysPopulation: Samples from six patients were consequently considered evaluable and were analyzed.
This outcome measure is applicable only for the Molecular biology study arm. Telomerase inhibition was assessed in PBMCs and summarised as 'yes-inhibited' vs. 'no inhibition'
Outcome measures
| Measure |
Molecular Biology Study
n=6 Participants
Molecular Biology Phase: Patients will receive one infusion of imetelstat prior to surgery. Surgery will take place 12-24 hours after the infusion of imetelstat. Patients will continue to receive therapy on the same schedule as the Phase II patients starting 14-21 days after surgery.
Phase II: Patients receive imetelstat sodium IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
imetelstat sodium: Given IV
|
Stratum-B
This is the Phase-II stratum for Recurrent or refractory high-grade glioma patients
|
Stratum-C
This is the Phase-II stratum for Recurrent or refractory ependymoma patients
|
Stratum-D
This is the Phase-II stratum for Recurrent or refractory diffuse intrinsic pontine glioma patients
|
|---|---|---|---|---|
|
Number of Participants With Telomerase Inhibition
|
5 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 years, from the date of initial treatment to the earliest date of disease progression, second malignancy or death for subjects who fail; and to the date of last contact for subjects who remain at risk for failure, assessed up to 3 yearsPopulation: Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Kaplan-Meier estimates of distributions of survival and PFS for all eligible subjects who received at least one dose of imetelstat will be provided separately.
Outcome measures
| Measure |
Molecular Biology Study
n=8 Participants
Molecular Biology Phase: Patients will receive one infusion of imetelstat prior to surgery. Surgery will take place 12-24 hours after the infusion of imetelstat. Patients will continue to receive therapy on the same schedule as the Phase II patients starting 14-21 days after surgery.
Phase II: Patients receive imetelstat sodium IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
imetelstat sodium: Given IV
|
Stratum-B
n=18 Participants
This is the Phase-II stratum for Recurrent or refractory high-grade glioma patients
|
Stratum-C
n=4 Participants
This is the Phase-II stratum for Recurrent or refractory ependymoma patients
|
Stratum-D
n=8 Participants
This is the Phase-II stratum for Recurrent or refractory diffuse intrinsic pontine glioma patients
|
|---|---|---|---|---|
|
Stratum-specific Progression-free Survival (PFS) (Phase II)
|
30 days
Standard Error 3.06
|
54.2 days
Standard Error 9.97
|
50.3 days
Standard Error 16.25
|
52.6 days
Standard Error 14.50
|
SECONDARY outcome
Timeframe: Up to 30 days. Due to small number of patients evaluable for this objective, we can only provide number of patients with the targetted markers as no analysis with PFS is possible.Population: This objective is for STRATUM-C patients only, having only 4 patients with TRAP, TERT and TERC levels measured. Due to small sample and having no objective response, association studies of these markers with Objective Reponse and PFS were not possible. Therefore, we only report the the percentage of cases with at least weak TRAP activity.
This secondary objective is for Stratum-B and C only, which enroll HGG and ependymoma patients. We will describe the evidence of telomerase expression by detection of hTERT mRNA and TERC RNA levels by qRT-PCR and telomerase activity by TRAP in archival tumor tissue; Association of telomerase positivity with objective response and PFS will not be able to be conducted as the study was terminated early and there was no objective response.
Outcome measures
| Measure |
Molecular Biology Study
n=4 Participants
Molecular Biology Phase: Patients will receive one infusion of imetelstat prior to surgery. Surgery will take place 12-24 hours after the infusion of imetelstat. Patients will continue to receive therapy on the same schedule as the Phase II patients starting 14-21 days after surgery.
Phase II: Patients receive imetelstat sodium IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
imetelstat sodium: Given IV
|
Stratum-B
This is the Phase-II stratum for Recurrent or refractory high-grade glioma patients
|
Stratum-C
This is the Phase-II stratum for Recurrent or refractory ependymoma patients
|
Stratum-D
This is the Phase-II stratum for Recurrent or refractory diffuse intrinsic pontine glioma patients
|
|---|---|---|---|---|
|
Number of Patients With Telomerase Expression Data by Detection of hTERT mRNA and TERC RNA Levels by qRT-PCR and Telomerase Activity by TRAP in Archival Tumor Tissue and to Explore Association of Telomerase Positivity With Objective Response and PFS
TRAP
|
3 Participants
|
—
|
—
|
—
|
|
Number of Patients With Telomerase Expression Data by Detection of hTERT mRNA and TERC RNA Levels by qRT-PCR and Telomerase Activity by TRAP in Archival Tumor Tissue and to Explore Association of Telomerase Positivity With Objective Response and PFS
TERT
|
3 Participants
|
—
|
—
|
—
|
|
Number of Patients With Telomerase Expression Data by Detection of hTERT mRNA and TERC RNA Levels by qRT-PCR and Telomerase Activity by TRAP in Archival Tumor Tissue and to Explore Association of Telomerase Positivity With Objective Response and PFS
TERC
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 30 daysPopulation: This study has been terminated early and the study team decided not to pursue this aim as the results would be inconclusive due to small sample size. Neither the neuroimaging, nor the biology data are available for these patients.
This outcome measure was for both Molecular biology and Phase II studies. We will not be able to present the results of this objective as the study was terminated early.
Outcome measures
Outcome data not reported
Adverse Events
Molecular Study-A
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Molecular Study-B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Stratum-A
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Stratum-B
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Stratum-C
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Stratum-D
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Molecular Study-A
n=1 participants at risk
Molecular Study arm for Recurrent or Refractory Medulloblastoma/PNET Patients
|
Molecular Study-B
n=1 participants at risk
Molecular Study arm for Recurrent or refractory high-grade glioma patients
|
Stratum-A
n=8 participants at risk
This is the Phase-II stratum for Recurrent or Refractory Medulloblastoma/PNET Patients
|
Stratum-B
n=18 participants at risk
This is the Phase-II stratum for Recurrent or refractory high-grade glioma patients
|
Stratum-C
n=4 participants at risk
This is the Phase-II stratum for Recurrent or refractory ependymoma patients
|
Stratum-D
n=8 participants at risk
This is the Phase-II stratum for Recurrent or refractory diffuse intrinsic pontine gliomas (DIPG) patients
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
1/4 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify[Death due to pr
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
2/8 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify[Progressive dis
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
1/4 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Hypoglossal nerve disorder
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
1/4 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial hemorrhage
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
16.7%
3/18 • Number of events 3 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Nervous system disorders - Other, specify[Cervical hemorrhage]
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Seizure
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify[increased secretions requiring freq
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
General disorders
Death, NOS
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
1/4 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
Other adverse events
| Measure |
Molecular Study-A
n=1 participants at risk
Molecular Study arm for Recurrent or Refractory Medulloblastoma/PNET Patients
|
Molecular Study-B
n=1 participants at risk
Molecular Study arm for Recurrent or refractory high-grade glioma patients
|
Stratum-A
n=8 participants at risk
This is the Phase-II stratum for Recurrent or Refractory Medulloblastoma/PNET Patients
|
Stratum-B
n=18 participants at risk
This is the Phase-II stratum for Recurrent or refractory high-grade glioma patients
|
Stratum-C
n=4 participants at risk
This is the Phase-II stratum for Recurrent or refractory ependymoma patients
|
Stratum-D
n=8 participants at risk
This is the Phase-II stratum for Recurrent or refractory diffuse intrinsic pontine gliomas (DIPG) patients
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
50.0%
4/8 • Number of events 4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
38.9%
7/18 • Number of events 7 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
50.0%
2/4 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Eye disorders
Eye disorders - Other, specify[Diplopia]
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Eye disorders
Scleral disorder
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
1/4 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
37.5%
3/8 • Number of events 3 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
11.1%
2/18 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
1/4 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
2/8 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
2/8 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
27.8%
5/18 • Number of events 5 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
1/4 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
2/8 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
50.0%
4/8 • Number of events 4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
22.2%
4/18 • Number of events 4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
1/4 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
37.5%
3/8 • Number of events 3 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
General disorders
Fever
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
1/4 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
General disorders
Infusion related reaction
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
37.5%
3/8 • Number of events 3 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
General disorders
Localized edema
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
General disorders
Pain
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
16.7%
3/18 • Number of events 3 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
50.0%
4/8 • Number of events 4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
44.4%
8/18 • Number of events 8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
75.0%
6/8 • Number of events 6 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
50.0%
4/8 • Number of events 4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
38.9%
7/18 • Number of events 7 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
37.5%
3/8 • Number of events 3 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Investigations
Hemoglobin increased
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Investigations
Investigations - Other, specify[increased PT]
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
62.5%
5/8 • Number of events 5 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
44.4%
8/18 • Number of events 8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
75.0%
6/8 • Number of events 6 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Investigations
Neutrophil count decreased
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
50.0%
4/8 • Number of events 4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
50.0%
9/18 • Number of events 9 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
50.0%
2/4 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
100.0%
8/8 • Number of events 8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
61.1%
11/18 • Number of events 11 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
1/4 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
62.5%
5/8 • Number of events 5 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Investigations
Weight loss
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Investigations
White blood cell decreased
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
37.5%
3/8 • Number of events 3 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
44.4%
8/18 • Number of events 8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
1/4 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
2/8 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
16.7%
3/18 • Number of events 3 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
1/4 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
11.1%
2/18 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
11.1%
2/18 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
37.5%
3/8 • Number of events 3 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
37.5%
3/8 • Number of events 3 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
2/8 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
2/8 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
2/8 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
11.1%
2/18 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify[Foot pain]
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
1/4 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Abducens nerve disorder
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
11.1%
2/18 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
2/8 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
2/8 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
2/8 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
1/4 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
100.0%
1/1 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
37.5%
3/8 • Number of events 3 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
22.2%
4/18 • Number of events 4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
2/8 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Hypoglossal nerve disorder
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
11.1%
2/18 • Number of events 2 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Nervous system disorders - Other, specify[Inability to tolerate own secretions]
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Seizure
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify[Urinary Hesitancy]
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
25.0%
1/4 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Vascular disorders
Flushing
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
5.6%
1/18 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
12.5%
1/8 • Number of events 1 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/18 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/4 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
0.00%
0/8 • Up to 2 years, which is the total possible therapy duration.
The AEs we report were experienced while the participants were on study.
|
Additional Information
Dr. Mehmet Kocak
University of Tennessee Health Science Center
Phone: 9014482937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place