Trial Outcomes & Findings for Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102 (NCT NCT03679754)
NCT ID: NCT03679754
Last Updated: 2025-08-28
Results Overview
Evaluation of adverse events as assessed by CTCAE v4.03. Adverse events will be summarized based on the incidence, intensity and type of adverse event.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
From the first dose of study treatment until 30 days after the last dose of veledimex, lasting approximately 5 months.
Results posted on
2025-08-28
Participant Flow
Participant milestones
| Measure |
Ad-RTS-hIL-12 + Veledimex
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Ad-RTS-hIL-12 + Veledimex
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Overall Study
Investigator request
|
1
|
Baseline Characteristics
Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102
Baseline characteristics by cohort
| Measure |
Ad-RTS-hIL-12 + Veledimex
n=36 Participants
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Age, Continuous
|
52.1 Years
n=99 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
|
Height
|
172.70 cm
n=99 Participants
|
|
Weight
|
76.6 kg
n=99 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study treatment until 30 days after the last dose of veledimex, lasting approximately 5 months.Population: The Full Analysis Set (FAS): Overall Safety Population (OSP) includes all subjects who have received at least one dose of veledimex (pretumor resection and) and/or all subjects who received Ad-RTS-hIL-12.
Evaluation of adverse events as assessed by CTCAE v4.03. Adverse events will be summarized based on the incidence, intensity and type of adverse event.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex
n=36 Participants
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Based on Evaluation of Adverse Events Summarized by Incidence, Intensity and Type of Adverse Event.
Any Drug-Related Serious TEAEs
|
4 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Based on Evaluation of Adverse Events Summarized by Incidence, Intensity and Type of Adverse Event.
Any Drug-Related TEAEs with Toxicity Grade ≥ 3
|
8 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Based on Evaluation of Adverse Events Summarized by Incidence, Intensity and Type of Adverse Event.
Any Drug-Related TEAEs Leading to Treatment Dose Modification
|
9 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Based on Evaluation of Adverse Events Summarized by Incidence, Intensity and Type of Adverse Event.
Any Drug-Related TEAEs Leading to Treatment Discontinuations
|
1 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Based on Evaluation of Adverse Events Summarized by Incidence, Intensity and Type of Adverse Event.
Any Drug-Related TEAEs Leading to Death
|
0 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Based on Evaluation of Adverse Events Summarized by Incidence, Intensity and Type of Adverse Event.
Any TEAEs
|
36 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Based on Evaluation of Adverse Events Summarized by Incidence, Intensity and Type of Adverse Event.
Any Serious TEAEs
|
10 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Based on Evaluation of Adverse Events Summarized by Incidence, Intensity and Type of Adverse Event.
Any TEAEs with Toxicity Grade ≥ 3
|
16 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Based on Evaluation of Adverse Events Summarized by Incidence, Intensity and Type of Adverse Event.
Any TEAEs Leading to Treatment Dose Modification
|
11 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Based on Evaluation of Adverse Events Summarized by Incidence, Intensity and Type of Adverse Event.
Any TEAEs Leading to Treatment Discontinuations
|
1 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Based on Evaluation of Adverse Events Summarized by Incidence, Intensity and Type of Adverse Event.
Any TEAEs Leading to Death
|
0 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Based on Evaluation of Adverse Events Summarized by Incidence, Intensity and Type of Adverse Event.
Any Drug-Related TEAEs
|
24 participants
|
PRIMARY outcome
Timeframe: Days 1 through 14 of each 21-day treatment cycle, over a total treatment period of up to 6 cycles (approximately 4 months)Population: The Full Analysis Set (FAS): Overall Safety Population (OSP) includes all subjects who have received at least one dose of veledimex (pretumor resection and) and/or all subjects who received Ad-RTS-hIL-12.
The Day 0 (as applicable), and Day 1 doses of veledimex were administered by study personnel at the study center. Thereafter, subjects could self-administer the remaining once daily dose of veledimex. Subjects were instructed to document veledimex dosing compliance in a subject diary, including the time each dose was taken, the time the subject ate the last meal prior to administration of veledimex, the number of capsules taken, whether the subject missed any veledimex doses, and reason for any missed doses. Investigational product container(s) with any remaining capsules were returned to the study staff on Day 15, and staff assessed dose compliance.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex
n=36 Participants
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Tolerability of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Will be Assessed Based on Expected Dose Compliance
100% Compliance
|
22 Participants
|
|
Tolerability of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Will be Assessed Based on Expected Dose Compliance
Less than 100% Compliance
|
14 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study drug for up to 2 years.Population: The Evaluable Safety Population (ESP) includes subjects who have received Ad-RTS-hIL-12 and at least one dose of veledimex after Ad-RTS-hIL-12 administration. The ESP is used for analysis of overall survival.
OS is defined as the duration of time from the first dose of study drug (Day 0) to the date of death from any cause in days or months. Subjects are censored based on the last date known to be alive. For example: * Subjects who discontinue the study without documentation of additional follow-up will be censored at the date of discontinuation. * Subjects who are lost to follow-up will be censored at last follow-up contact date. * Subjects still alive up to 2 years from the first dose of study drug are classified as censored and as having completed all follow-up scheduling.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex
n=36 Participants
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Determine the Overall Survival (OS) of Ad-RTS-hIL-12 + Veledimex
|
10.68 Months
Interval 7.28 to 20.67
|
SECONDARY outcome
Timeframe: 15 daysPopulation: All Subjects with available plasma-time concentration data post dose on Day 14 and predose on Day 15 are included in the PK Population.
The maximum plasma concentration (Cmax) of veledimex
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex
n=17 Participants
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Veledimex Pharmacokinetic Profile: Maximum Plasma Concentration (Cmax)
|
68.69 ng/mL
Standard Deviation 41.95
|
SECONDARY outcome
Timeframe: 15 daysPopulation: All Subjects with available plasma-time concentration data post dose on Day 14 and predose on Day 15 are included in the PK Population.
Time to maximum plasma concentration (Tmax) of veledimex. Tmax was estimated based on time of maximum concentration (Cmax) from predose (Day 0 or 14) to predose the following day (Day 1 or 15).
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex
n=17 Participants
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Veledimex Pharmacokinetic Profile: Time to Maximum Plasma Concentration (Tmax)
|
4.00 hr
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: 15 daysPopulation: All subjects with available plasma-time concentration data post dose (steady state) on Day 14 and predose on Day 15 are included in the PK Population.
Half-life (t1/2) of veledimex
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex
n=17 Participants
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Veledimex Pharmacokinetic Profile: Half-life (t1/2)
|
16.4 hr
Standard Deviation 19.4
|
SECONDARY outcome
Timeframe: 15 daysPopulation: All subjects with available plasma-time concentration data post dose (steady state) on Day 14 and predose on Day 15 are included in the PK Population.
Area-under-the-concentration versus time curve (AUC) of veledimex from Day 14 predose to Day 15 predose. AUC was estimated using the elimination rate constant k, where k = ln(Cmax/Ctrough)/time difference and AUC is approximately Cmax/k.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex
n=17 Participants
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Veledimex Pharmacokinetic Profile: Area-under-the-concentration Versus Time Curve (AUC)
|
771.4 ng*hr/mL
Standard Deviation 364.5
|
SECONDARY outcome
Timeframe: 15 daysPopulation: The PK blood sample collection was performed either pre-dose or 3-5 hours post-dose, therefore only Cmax and Ctrough will be summarized and plotted. There will be no parameters including time to maximum plasma concentration (Tmax), half-life (t1/2), area under the curve (AUC), volume of distribution (Vd), and clearance (CL).
Volume of distribution (Vd) of veledimex. Vd was calculated using AUC approximated as described in the Outcome Measure Description for Outcome Measure 6.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex
n=17 Participants
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Veledimex Pharmacokinetic Profile: Volume of Distribution (Vd)
|
683 mL
Standard Deviation 613
|
SECONDARY outcome
Timeframe: 15 daysPopulation: All Subjects with available plasma-time concentration data post dose on Day 14 and predose on Day 15 are included in the PK Population.
Clearance (CL) of veledimex. CL was calculated using AUC approximated as described in the Outcome Measure Description for Outcome Measure 6.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex
n=17 Participants
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Veledimex Pharmacokinetic Profile: Clearance (CL)
|
32.6 mL/hr
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: Day 0 (at the time of tumor resection)Population: All Subjects with available serum-time concentration data are included in the PK Population.
Veledimex concentration ratio was calculated based on the Day 0 tumor and plasma PK results.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex
n=36 Participants
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Veledimex Concentration Ratio Between the Brain Tumor and the Blood
|
0.63 ratio
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: The Evaluable Safety Population (ESP) includes subjects who have received Ad-RTS-hIL-12 and at least one dose of veledimex after Ad-RTS-hIL-12 administration. The Evaluable Safety Population (ESP) includes subjects who have received Ad-RTS-hIL-12 and at least one dose of veledimex after Ad-RTS-hIL-12 administration. The ESP is to be used for analysis of dose limiting toxicities, overall survival and progression free survival and finding the maximum tolerated dose.
For the ORR calculation, responders are defined as those experiencing a confirmed complete response or confirmed partial response. Non-responders are those either with stable or progressive disease. Those subjects that cannot be assessed will be treated as non-responders for the purposes of deriving the percentage of responders and confidence intervals. Overall Response was assessed at multiple timepoints (day 56, week 16, week 24, and week 48) by the study investigators. Changes to the original plan for exploration of estimates of efficacy are summarized below. • The best overall response (BOR) endpoint was added to the efficacy assessment and reported here.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex
n=36 Participants
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Tumor Objective Response Rate (ORR)
Complete Response
|
1 Participants
|
|
Tumor Objective Response Rate (ORR)
Partial Response
|
1 Participants
|
|
Tumor Objective Response Rate (ORR)
Stable Disease
|
27 Participants
|
|
Tumor Objective Response Rate (ORR)
Progressive Disease
|
6 Participants
|
|
Tumor Objective Response Rate (ORR)
Not Evaluable
|
0 Participants
|
|
Tumor Objective Response Rate (ORR)
No Response
|
1 Participants
|
|
Tumor Objective Response Rate (ORR)
Missing
|
0 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study drug for up to 2 years.Population: The Evaluable Safety Population (ESP) includes subjects who have received Ad-RTS-hIL-12 and at least one dose of veledimex after Ad-RTS-hIL-12 administration.
PFS (progression free survival) is the time in months from the first treatment (either veledimex or Ad-RTS-hIL-12) to the first assessment on which the overall response is reported as disease progression. Subjects withdrawing from the study will be censored at their last non progressive disease response assessment. If a subject does not have a non-progressive disease response assessment, the subject will be censored on the date of the first treatment as described above.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex
n=36 Participants
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Progression Free Survival (PFS)
|
52.17 Days
Standard Deviation 39.1
|
SECONDARY outcome
Timeframe: From the first dose of study drug for up to 2 years.Population: The Evaluable Safety Population (ESP) includes subjects who have received Ad-RTS-hIL-12 and at least one dose of veledimex after Ad-RTS-hIL-12 administration. The ESP is denoted as the PP population in this uncontrolled setting.
PSP Progression free survival was originally defined for determination of PSP requiring confirmation of progression based on RANO/iRANO criteria guidelines.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex
n=36 Participants
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Rate of Pseudo-progression (PSP)
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Due to the study's early termination and limited enrollment, a decision was made not to perform the planned immunohistochemistry (IHC) analyses on collected tumor biopsies. Therefore, no data are available for this endpoint, and zero subjects were analyzed. These analyses will not be performed in the future, and data for this outcome measure will not be reported.
Evaluation in changes in immune cell population markers, such as CD3 and CD8 in tumor
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Samples were collected at Baseline (Day 1), Day 3, Day 8, and Day 15 of Cycle 1, and at the 30-day follow-up visit.Population: The Evaluable Safety Population (ESP) includes subjects who have received Ad-RTS-hIL-12 and at least one dose of veledimex after Ad-RTS-hIL-12 administration. The ESP is denoted as the Per Protocol population in this uncontrolled setting.
Serum concentrations of IL-12 were measured at multiple timepoints post-dose. For each participant, the peak (maximum) concentration observed from Day 3 through the 30-day follow-up visit was identified. This measure summarizes the mean of those individual peak concentrations.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex
n=36 Participants
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Peak Serum Concentration of Interleukin-12 (IL-12)
|
20.3 pg/mL
Standard Error 5.4
|
SECONDARY outcome
Timeframe: Samples were collected at Baseline (Day 1), Day 3, Day 8, and Day 15 of Cycle 1, and at the 30-day follow-up visitPopulation: The Evaluable Safety Population (ESP) includes subjects who have received Ad-RTS-hIL-12 and at least one dose of veledimex after Ad-RTS-hIL-12 administration. The ESP is denoted as the Per Protocol population in this uncontrolled setting.
Serum concentrations of IFN-γ were measured at multiple timepoints post-dose. For each participant, the peak (maximum) concentration observed from Day 3 through the 30-day follow-up visit was identified. This measure summarizes the mean of those individual peak concentrations.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex
n=36 Participants
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Peak Serum Concentration of Interferon-gamma (IFN-γ)
|
39.3 pg/mL
Standard Error 27.3
|
Adverse Events
Ad-RTS-hIL-12 + Veledimex
Serious events: 10 serious events
Other events: 36 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Ad-RTS-hIL-12 + Veledimex
n=36 participants at risk
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Nervous system disorders
Seizure
|
5.6%
2/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Aphasia
|
5.6%
2/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Brain Oedema
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Cerebrovascular Accident
|
5.6%
2/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Dizziness
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Partial Seizures
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
General disorders
Pyrexia
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
Neutrophil Count Decreased
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Psychiatric disorders
Mental Status Changes
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
Other adverse events
| Measure |
Ad-RTS-hIL-12 + Veledimex
n=36 participants at risk
Intratumoral Ad-RTS-hIL-12 and oral veledimex
Ad-RTS-hIL-12:
\- intratumoral injection of Ad-RTS-hIL-12
veledimex: - 20mg/day
\- 15 oral daily doses of veledimex
|
|---|---|
|
Nervous system disorders
Headache
|
55.6%
20/36 • Number of events 27 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Seizure
|
19.4%
7/36 • Number of events 10 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Aphasia
|
13.9%
5/36 • Number of events 7 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Hemiparesis
|
16.7%
6/36 • Number of events 7 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Encephalopathy
|
8.3%
3/36 • Number of events 4 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Brain oedema
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Ataxia
|
5.6%
2/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Cerebrovascular Accident
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Cognitive Disorder
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Lethargy
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Dysarthria
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Haemorrhage Intracranial
|
5.6%
2/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Speech Disorder
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Tremor
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
2.8%
1/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Facial Paralysis
|
2.8%
1/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Cerebrospinal Fluid Retention
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Facial Paresis
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Hypoaesthesia
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Neuralgia
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Pyramidal Tract Syndrome
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Subdural Hygroma
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Nervous system disorders
Syncope
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Gastrointestinal disorders
Nausea
|
47.2%
17/36 • Number of events 19 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Gastrointestinal disorders
Constipation
|
19.4%
7/36 • Number of events 9 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
3/36 • Number of events 4 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Gastrointestinal disorders
Dry Mouth
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
Lymphocyte Count Decreased
|
52.8%
19/36 • Number of events 38 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
Platelet Count Decreased
|
30.6%
11/36 • Number of events 14 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
White Blood Cell Count Decreased
|
16.7%
6/36 • Number of events 16 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
Aspartate Aminotransferase Increased
|
16.7%
6/36 • Number of events 9 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
Alanine Aminotransferase Increased
|
11.1%
4/36 • Number of events 6 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
Neutrophil Count Decreased
|
11.1%
4/36 • Number of events 8 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
5.6%
2/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
Amylase Increased
|
2.8%
1/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
C-Reactive Protein Increased
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
Blood Albumin Decreased
|
5.6%
2/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
International Normalised Ratio Increased
|
5.6%
2/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
Blood Calcium Decreased
|
2.8%
1/36 • Number of events 8 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
Blood Potassium Decreased
|
2.8%
1/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
Blood Bilirubin Increased
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
Heart Rate Increased
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
Vitamin D Decreased
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Investigations
White Blood Cell Count Increased
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
6/36 • Number of events 9 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
19.4%
7/36 • Number of events 7 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.9%
5/36 • Number of events 8 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.6%
2/36 • Number of events 5 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.6%
2/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.3%
3/36 • Number of events 3 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
5.6%
2/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
General disorders
Pyrexia
|
22.2%
8/36 • Number of events 13 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
General disorders
Fatigue
|
8.3%
3/36 • Number of events 3 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
General disorders
Gait Disturbance
|
5.6%
2/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
General disorders
Pain
|
11.1%
4/36 • Number of events 4 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
General disorders
Influenza Like Illness
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
27.8%
10/36 • Number of events 12 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Infections and infestations
Urinary Tract Infection
|
8.3%
3/36 • Number of events 3 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Infections and infestations
Oral Candidiasis
|
5.6%
2/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Infections and infestations
Wound Infection
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
5.6%
2/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
2.8%
1/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Psychiatric disorders
Confusional State
|
5.6%
2/36 • Number of events 3 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Psychiatric disorders
Insomnia
|
5.6%
2/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Psychiatric disorders
Abulia
|
2.8%
1/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Psychiatric disorders
Agitation
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Psychiatric disorders
Anxiety
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Psychiatric disorders
Depression
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Vascular disorders
Hypertension
|
13.9%
5/36 • Number of events 10 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Vascular disorders
Hypotension
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Vascular disorders
Hot Flush
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
2/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
5.6%
2/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Eye disorders
Periorbital Oedema
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Eye disorders
Vision Blurred
|
5.6%
2/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Eye disorders
Blepharitis
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Eye disorders
Blepharospasm
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Eye disorders
Retinal Exudates
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Eye disorders
Retinal Tear
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Renal and urinary disorders
Urinary Retention
|
5.6%
2/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Ear and labyrinth disorders
Hypoacusis
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Congenital, familial and genetic disorders
Spinal Muscular Atrophy
|
2.8%
1/36 • Number of events 2 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
|
Hepatobiliary disorders
Hepatic Lesion
|
2.8%
1/36 • Number of events 1 • All-cause mortality was assessed from the first dose of study treatment for up to 2 years. All other adverse events were collected from the first dose of study treatment until 30 days after the last dose of veledimex (approximately 5 months).
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs), Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure shall not occur until (i) twenty-four (24) months have elapsed since Sponsor has notified Institution of the completion of the multi-center Study in order for Sponsor to comply with its obligations under 21 CFR 312.53(c)(4), or (ii) after the publication of the multi-center Study data, if the Study is a multi-center Study or Sponsor confirms in writing there will be no multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER