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NCT03330197 · OUTCOME

Subjects With Ad-RTS-hIL-12 and Veledimex Related Adverse Events Will be Assessed for Safety by CTCAE v5.0

A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG · Source last updated 2025-08-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
2 Years

What was measured

Subjects with Ad-RTS-hIL-12 and veledimex related adverse events will be assessed for safety by CTCAE v5.0

Analysis population: The Full Analysis Set (FAS) or the OSP includes every subject who received at least one dose of any study drug recorded in the Data Management (DM) database excluding screen failures. • The data analysis for Adverse Events or other Safety variables will be performed on the OSP.

Groups in this outcome

Arm 1 - Closed

Intratumoral Ad-RTS-hIL-12 freehand injection after tumor resection and oral veledimex (activator ligand) in pediatric patients with brain tumors. Ad-RTS-hIL-12: 2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12 Oral Veledimex - Arm 1 (Pediatric Brain Tumor): * Planned: 1 dose level (10mg/day) 15 oral daily doses of veledimex * Actual: All patients received 1 dose level (10 mg/day veledimex)

Arm 2 - Closed

Intratumoral Ad-RTS-hIL-12 stereotactic injection and oral veledimex (activator ligand) in pediatric patients with DIPG. Ad-RTS-hIL-12: 2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12 Oral Veledimex - Arm 2 (DIPG): * Planned:2 dose levels (10mg/day, 20mg/day) * Actual: 1 patient received 5 mg/day veledimex. The other patient did not receive veledimex due to SAE.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm 1 - Closed3
Arm 2 - Closed2

Reported measurements

WHITE BLOOD CELL COUNT DECREASED (INVESTIGATIONS)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 - Closed2Not reportedNot reportedNot reportedNot reported
Arm 2 - Closed2Not reportedNot reportedNot reportedNot reported
LYMPHOCYTE COUNT DECREASED (INVESTIGATIONS)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 - Closed2Not reportedNot reportedNot reportedNot reported
Arm 2 - Closed2Not reportedNot reportedNot reportedNot reported
VOMITING (GASTROINTESTINAL DISORDERS)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 - Closed2Not reportedNot reportedNot reportedNot reported
Arm 2 - Closed1Not reportedNot reportedNot reportedNot reported
HEADACHE (NERVOUS SYSTEM DISORDERS)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 - Closed2Not reportedNot reportedNot reportedNot reported
Arm 2 - Closed1Not reportedNot reportedNot reportedNot reported
PYREXIA (GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 - Closed1Not reportedNot reportedNot reportedNot reported
Arm 2 - Closed2Not reportedNot reportedNot reportedNot reported
ANAEMIA (BLOOD AND LYMPHATIC SYSTEM DISORDERS)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 - Closed2Not reportedNot reportedNot reportedNot reported
Arm 2 - Closed0Not reportedNot reportedNot reportedNot reported
APHASIA (NERVOUS SYSTEM DISORDERS)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 - Closed1Not reportedNot reportedNot reportedNot reported
Arm 2 - Closed1Not reportedNot reportedNot reportedNot reported
FATIGUE (GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 - Closed1Not reportedNot reportedNot reportedNot reported
Arm 2 - Closed1Not reportedNot reportedNot reportedNot reported
HYPONATRAEMIA (METABOLISM AND NUTRITION DISORDERS)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 - Closed2Not reportedNot reportedNot reportedNot reported
Arm 2 - Closed0Not reportedNot reportedNot reportedNot reported
NAUSEA (GASTROINTESTINAL DISORDERS)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 - Closed1Not reportedNot reportedNot reportedNot reported
Arm 2 - Closed1Not reportedNot reportedNot reportedNot reported
PLATELET COUNT DECREASED (INVESTIGATIONS)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 - Closed2Not reportedNot reportedNot reportedNot reported
Arm 2 - Closed0Not reportedNot reportedNot reportedNot reported
TACHYCARDIA (CARDIAC DISORDERS)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 - Closed0Not reportedNot reportedNot reportedNot reported
Arm 2 - Closed2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    title
    WHITE BLOOD CELL COUNT DECREASED (INVESTIGATIONS)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    title
    LYMPHOCYTE COUNT DECREASED (INVESTIGATIONS)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    VOMITING (GASTROINTESTINAL DISORDERS)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    HEADACHE (NERVOUS SYSTEM DISORDERS)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
    title
    PYREXIA (GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    ANAEMIA (BLOOD AND LYMPHATIC SYSTEM DISORDERS)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    APHASIA (NERVOUS SYSTEM DISORDERS)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    FATIGUE (GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    HYPONATRAEMIA (METABOLISM AND NUTRITION DISORDERS)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    NAUSEA (GASTROINTESTINAL DISORDERS)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    PLATELET COUNT DECREASED (INVESTIGATIONS)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    TACHYCARDIA (CARDIAC DISORDERS)
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      2
    units
    Participants
description
Subjects with Ad-RTS-hIL-12 and veledimex related adverse events will be assessed for safety by CTCAE v5.0
groups
  1. description
    Intratumoral Ad-RTS-hIL-12 freehand injection after tumor resection and oral veledimex (activator ligand) in pediatric patients with brain tumors. Ad-RTS-hIL-12: 2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12 Oral Veledimex - Arm 1 (Pediatric Brain Tumor): * Planned: 1 dose level (10mg/day) 15 oral daily doses of veledimex * Actual: All patients received 1 dose level (10 mg/day veledimex)
    id
    OG000
    title
    Arm 1 - Closed
  2. description
    Intratumoral Ad-RTS-hIL-12 stereotactic injection and oral veledimex (activator ligand) in pediatric patients with DIPG. Ad-RTS-hIL-12: 2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12 Oral Veledimex - Arm 2 (DIPG): * Planned:2 dose levels (10mg/day, 20mg/day) * Actual: 1 patient received 5 mg/day veledimex. The other patient did not receive veledimex due to SAE.
    id
    OG001
    title
    Arm 2 - Closed
param Type
NUMBER
population Description
The Full Analysis Set (FAS) or the OSP includes every subject who received at least one dose of any study drug recorded in the Data Management (DM) database excluding screen failures. • The data analysis for Adverse Events or other Safety variables will be performed on the OSP.
reporting Status
POSTED
time Frame
2 Years
title
Subjects With Ad-RTS-hIL-12 and Veledimex Related Adverse Events Will be Assessed for Safety by CTCAE v5.0
type
SECONDARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice