Trial Outcomes & Findings for Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma (NCT NCT03072134)
NCT ID: NCT03072134
Last Updated: 2023-01-20
Results Overview
Using a 3+3 dose escalation design, three to six patients were to be enrolled per dose in each of the 3 cohorts. If no patients in the cohort experienced a dose-limiting toxicity (DLT), then the next cohort enrolled a minimum of 3 patients. If one of three patients experienced a DLT, then 3 more patients were evaluated at that dose level. If none of these three additional patients experienced a DLT, then dose escalation occurs, unless this is the highest dose, in which case dose escalation is stopped and the highest dose is declared the MTD. If 1 or more of these additional 3 patients had a DLT, then three additional patients may be entered, after discussion with the sponsor, at the next lowest does level if only three patients were treated previously at that dose. If two or more patients experienced a DLT Dose escalation will be stopped; 3 more patients could be added with sponsor approval at the next lower dose level.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Two years
Results posted on
2023-01-20
Participant Flow
April 24, 2017 thru Nov 13, 2019 at Northwestern University and City of Hope.
Arm A, for subjects with unresectable disease, was not opened due to limited product availability
Participant milestones
| Measure |
Resectable Disease
Patients with resectable tumors will undergo a resection followed by injection of neural stem cells loaded with the virus and then receive standard chemoradiotherapy. The unresectable cohort was not able to be opened due to limited product availability.
Neural stem cells loaded with an oncolytic adenovirus: The primary objectives are to evaluate the safety of the combined therapy and determine the maximum tolerated dose (MTD) for a future Phase II study.
|
|---|---|
|
Cohort 1: 0.5x10^8/NSCs/6.25x10^10 vp
STARTED
|
3
|
|
Cohort 1: 0.5x10^8/NSCs/6.25x10^10 vp
COMPLETED
|
3
|
|
Cohort 1: 0.5x10^8/NSCs/6.25x10^10 vp
NOT COMPLETED
|
0
|
|
Cohort 2: 1.0x10^8 NSCs/1.25x10^10 vp
STARTED
|
3
|
|
Cohort 2: 1.0x10^8 NSCs/1.25x10^10 vp
COMPLETED
|
3
|
|
Cohort 2: 1.0x10^8 NSCs/1.25x10^10 vp
NOT COMPLETED
|
0
|
|
Cohort 3: 1.5x10^8 NSCs/1.875x10^10 vp
STARTED
|
6
|
|
Cohort 3: 1.5x10^8 NSCs/1.875x10^10 vp
COMPLETED
|
6
|
|
Cohort 3: 1.5x10^8 NSCs/1.875x10^10 vp
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma
Baseline characteristics by cohort
| Measure |
Arm B: Resectable Disease Cohort 1
n=3 Participants
Patients with resectable tumors will undergo a resection followed by injection of neural stem cells loaded with the virus at dose level 0.5x10\^8 NSCs loading 6.25x10\^10 vp and then receive standard chemoradiotherapy.
Neural stem cells loaded with an oncolytic adenovirus: The primary objectives are to evaluate the safety of the combined therapy and determine the maximum tolerated dose (MTD) for a future Phase II study.
|
Arm B: Resectable Disease Cohort 2
n=3 Participants
Patients with resectable tumors will undergo a resection followed by injection of neural stem cells loaded with the virus at dose level 1.0x10\^8 NSCs loading 1.25x10\^11 vp and then receive standard chemoradiotherapy.
Neural stem cells loaded with an oncolytic adenovirus: The primary objectives are to evaluate the safety of the combined therapy and determine the maximum tolerated dose (MTD) for a future Phase II study.
|
Arm B: Resectable Disease Cohort 3
n=6 Participants
Patients with resectable tumors will undergo a resection followed by injection of neural stem cells loaded with the virus at dose level 1.5x10\^8 NSCs loading 1.875x10\^11 vp and then receive standard chemoradiotherapy.
Neural stem cells loaded with an oncolytic adenovirus: The primary objectives are to evaluate the safety of the combined therapy and determine the maximum tolerated dose (MTD) for a future Phase II study.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
12 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Two yearsPopulation: No screen failures were encountered and all 12 patients were evaluable.
Using a 3+3 dose escalation design, three to six patients were to be enrolled per dose in each of the 3 cohorts. If no patients in the cohort experienced a dose-limiting toxicity (DLT), then the next cohort enrolled a minimum of 3 patients. If one of three patients experienced a DLT, then 3 more patients were evaluated at that dose level. If none of these three additional patients experienced a DLT, then dose escalation occurs, unless this is the highest dose, in which case dose escalation is stopped and the highest dose is declared the MTD. If 1 or more of these additional 3 patients had a DLT, then three additional patients may be entered, after discussion with the sponsor, at the next lowest does level if only three patients were treated previously at that dose. If two or more patients experienced a DLT Dose escalation will be stopped; 3 more patients could be added with sponsor approval at the next lower dose level.
Outcome measures
| Measure |
Arm B/Cohort 1
n=3 Participants
Patients with resectable tumors will undergo a resection followed by injection of neural stem cells loaded with the virus (dose: 0.5x10\^8/NSCs/6.25x10\^10 vp) and then receive standard chemoradiotherapy. No dose limiting toxicities were experienced in this cohort.
|
Arm B/Cohort 2
n=3 Participants
Patients with resectable tumors will undergo a resection followed by injection of neural stem cells loaded with the virus (dose: 1.0x10\^8 NSCs/1.25x10\^10 vp) and then receive standard chemoradiotherapy. No dose limiting toxicities were experienced in this cohort.
|
ArmB/Cohort 3
n=6 Participants
.5x10\^8 NSCs/1.875x10\^10 vp
Patients with resectable tumors will undergo a resection followed by injection of neural stem cells loaded with the virus (dose: 1.5x10\^8 NSCs/1.875x10\^10 vp) and then receive standard chemoradiotherapy. One dose limiting toxicity event was experienced in this cohort, prompting 3 additional patients being added to the cohort; no dose limiting toxicities were experienced in this addition to the cohort, and this dose was determined to be the MTD.
|
|---|---|---|---|
|
Percentage of Dose-limiting Toxicities
|
0 Percentage of dose-limiting toxicities
|
0 Percentage of dose-limiting toxicities
|
17 Percentage of dose-limiting toxicities
|
SECONDARY outcome
Timeframe: Two yearsPopulation: Nine of 12 patients had measureable disease post-surgery and were followed with serial MRIs.
Per Response Assessment in Neuro-Oncology Criteria (RANO, 2017) for target lesions as assessed by MRI: Complete Response (CR): The enhancing tumor is no longer seen by neuroimaging; Partial Response (PR): Decrease of ≥ 50% in the product of two diameters with the patient on a stable or decreasing dose of steroids; Minor Response (MR): Decrease in diameter products of \< 50% with the patient on a stable or decreasing dose of steroids; Stable Disease (SD): The scan shows no change. Patients should be receiving stable or decreasing doses of steroids; Progression (P): Increase of \> 25% in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. A concomitant decrease in steroid dose will rule out a progression designation during the first two months after completion of radiation; Pseudoprogression (PP): Radiological changes without concomitant neurological changes.
Outcome measures
| Measure |
Arm B/Cohort 1
n=12 Participants
Patients with resectable tumors will undergo a resection followed by injection of neural stem cells loaded with the virus (dose: 0.5x10\^8/NSCs/6.25x10\^10 vp) and then receive standard chemoradiotherapy. No dose limiting toxicities were experienced in this cohort.
|
Arm B/Cohort 2
Patients with resectable tumors will undergo a resection followed by injection of neural stem cells loaded with the virus (dose: 1.0x10\^8 NSCs/1.25x10\^10 vp) and then receive standard chemoradiotherapy. No dose limiting toxicities were experienced in this cohort.
|
ArmB/Cohort 3
.5x10\^8 NSCs/1.875x10\^10 vp
Patients with resectable tumors will undergo a resection followed by injection of neural stem cells loaded with the virus (dose: 1.5x10\^8 NSCs/1.875x10\^10 vp) and then receive standard chemoradiotherapy. One dose limiting toxicity event was experienced in this cohort, prompting 3 additional patients being added to the cohort; no dose limiting toxicities were experienced in this addition to the cohort, and this dose was determined to be the MTD.
|
|---|---|---|---|
|
Assessment of Tumor Response.
Percentage of participants with tumor response: Partial
|
8 Percentage of participants
|
—
|
—
|
|
Assessment of Tumor Response.
Percentage of participants with tumor response: Pseudoprogression
|
8 Percentage of participants
|
—
|
—
|
|
Assessment of Tumor Response.
Percentage of participants with tumor response: Stable disease
|
84 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: two yearsMedian progression-free survival
Outcome measures
| Measure |
Arm B/Cohort 1
n=12 Participants
Patients with resectable tumors will undergo a resection followed by injection of neural stem cells loaded with the virus (dose: 0.5x10\^8/NSCs/6.25x10\^10 vp) and then receive standard chemoradiotherapy. No dose limiting toxicities were experienced in this cohort.
|
Arm B/Cohort 2
Patients with resectable tumors will undergo a resection followed by injection of neural stem cells loaded with the virus (dose: 1.0x10\^8 NSCs/1.25x10\^10 vp) and then receive standard chemoradiotherapy. No dose limiting toxicities were experienced in this cohort.
|
ArmB/Cohort 3
.5x10\^8 NSCs/1.875x10\^10 vp
Patients with resectable tumors will undergo a resection followed by injection of neural stem cells loaded with the virus (dose: 1.5x10\^8 NSCs/1.875x10\^10 vp) and then receive standard chemoradiotherapy. One dose limiting toxicity event was experienced in this cohort, prompting 3 additional patients being added to the cohort; no dose limiting toxicities were experienced in this addition to the cohort, and this dose was determined to be the MTD.
|
|---|---|---|---|
|
Progression-free Survival
|
9.1 Months
Interval 8.5 to 36.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Two yearsMedian overall survival
Outcome measures
| Measure |
Arm B/Cohort 1
n=12 Participants
Patients with resectable tumors will undergo a resection followed by injection of neural stem cells loaded with the virus (dose: 0.5x10\^8/NSCs/6.25x10\^10 vp) and then receive standard chemoradiotherapy. No dose limiting toxicities were experienced in this cohort.
|
Arm B/Cohort 2
Patients with resectable tumors will undergo a resection followed by injection of neural stem cells loaded with the virus (dose: 1.0x10\^8 NSCs/1.25x10\^10 vp) and then receive standard chemoradiotherapy. No dose limiting toxicities were experienced in this cohort.
|
ArmB/Cohort 3
.5x10\^8 NSCs/1.875x10\^10 vp
Patients with resectable tumors will undergo a resection followed by injection of neural stem cells loaded with the virus (dose: 1.5x10\^8 NSCs/1.875x10\^10 vp) and then receive standard chemoradiotherapy. One dose limiting toxicity event was experienced in this cohort, prompting 3 additional patients being added to the cohort; no dose limiting toxicities were experienced in this addition to the cohort, and this dose was determined to be the MTD.
|
|---|---|---|---|
|
Overall Survival
|
18.4 Months
Interval 6.5 to 36.0
|
—
|
—
|
Adverse Events
Resectable Disease Cohort 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Resectable Disease Cohort 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Resectable Disease Cohort 3
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Resectable Disease Cohort 1
n=3 participants at risk
Patients with resectable tumors underwent surgical resection followed by injection of neural stem cells loaded with the virus (0.5x10\^8 NSCs loading 6.25x10\^10 vp) and then received standard chemoradiotherapy.
|
Resectable Disease Cohort 2
n=3 participants at risk
Patients with resectable tumors underwent surgical resection followed by injection of neural stem cells loaded with the virus (.0x10\^8 NSCs loading 1.25x10\^11 vp) and then received standard chemoradiotherapy.
|
Resectable Disease Cohort 3
n=6 participants at risk
Patients with resectable tumors underwent surgical resection followed by injection of neural stem cells loaded with the virus (1.5x10\^8 NSCs loading 1.875x10\^11 vp) and then received standard chemoradiotherapy.
|
|---|---|---|---|
|
Nervous system disorders
Meningitis
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Vascular disorders
Thromboembolic Event
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Nervous system disorders
Edema, cerebral
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
Other adverse events
| Measure |
Resectable Disease Cohort 1
n=3 participants at risk
Patients with resectable tumors underwent surgical resection followed by injection of neural stem cells loaded with the virus (0.5x10\^8 NSCs loading 6.25x10\^10 vp) and then received standard chemoradiotherapy.
|
Resectable Disease Cohort 2
n=3 participants at risk
Patients with resectable tumors underwent surgical resection followed by injection of neural stem cells loaded with the virus (.0x10\^8 NSCs loading 1.25x10\^11 vp) and then received standard chemoradiotherapy.
|
Resectable Disease Cohort 3
n=6 participants at risk
Patients with resectable tumors underwent surgical resection followed by injection of neural stem cells loaded with the virus (1.5x10\^8 NSCs loading 1.875x10\^11 vp) and then received standard chemoradiotherapy.
|
|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
66.7%
2/3 • Number of events 2 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • Number of events 3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
100.0%
3/3 • Number of events 3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
50.0%
3/6 • Number of events 7 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Cardiac disorders
Sinus bradycardia
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
66.7%
2/3 • Number of events 3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
50.0%
3/6 • Number of events 3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
66.7%
2/3 • Number of events 2 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
50.0%
3/6 • Number of events 4 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Number of events 2 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 2 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 4 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 2 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
2/6 • Number of events 4 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Gastrointestinal disorders
Malaise
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 2 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
2/6 • Number of events 2 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 2 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
2/6 • Number of events 3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Investigations
Lymphocyte count decreased
|
100.0%
3/3 • Number of events 7 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
100.0%
3/3 • Number of events 8 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
83.3%
5/6 • Number of events 8 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Number of events 3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 2 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
100.0%
3/3 • Number of events 5 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
100.0%
6/6 • Number of events 7 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
3/3 • Number of events 5 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
66.7%
2/3 • Number of events 2 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
100.0%
6/6 • Number of events 6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
66.7%
2/3 • Number of events 3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
2/6 • Number of events 6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
66.7%
2/3 • Number of events 2 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 2 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Nervous system disorders
Facial muscle weakness
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
100.0%
3/3 • Number of events 5 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
100.0%
6/6 • Number of events 10 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
100.0%
3/3 • Number of events 3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
50.0%
3/6 • Number of events 3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Skin and subcutaneous tissue disorders
Rash, maculopapular
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 2 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
100.0%
3/3 • Number of events 6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
83.3%
5/6 • Number of events 11 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Vascular disorders
Thromboembolic event
|
66.7%
2/3 • Number of events 4 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Nervous system disorders
Stroke
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
General disorders
Fever
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 2 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 2 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Injury, poisoning and procedural complications
Dermatitis, radiation
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 2 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
2/6 • Number of events 3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 2 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/6 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
33.3%
1/3 • Number of events 2 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
General disorders
Pain
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Investigations
INR increased
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Nervous system disorders
Nervous system disorders, other
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
0.00%
0/3 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
16.7%
1/6 • Number of events 1 • Two years and 7 months
Number of patients in each cohort affected by serious adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place