Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-25 @ 3:20 PM
NCT ID:
NCT02465268
Description:
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
Frequency Threshold:
1
Time Frame:
AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
Study:
NCT02465268
Study Brief:
Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| pp65-shLAMP DC With GM-CSF and Td (Arm 1) | The active treatment group was arms 1 and 2 combined. Arm 1: pp65-shLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep) Arm 2: pp65-flLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep) | 28 | None | 8 | 36 | 16 | 36 | View |
| pp65-flLAMP DC With GM-CSF and Td (Arm 2) | The active treatment group was arms 1 and 2 combined. Arm 1: pp65-shLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep) Arm 2: pp65-flLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep) | 31 | None | 6 | 34 | 11 | 34 | View |
| Unpulsed PBMC and Saline (Arm 3) | The control group was Arm 3, Unpulsed PBMCs (saline skin prep) Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms. | 31 | None | 5 | 41 | 13 | 41 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bruising | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Gastrointestinal - Other (Specify, appendicitis) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hematoma | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sodium, serum-low (hyponatremia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Left-sided | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| CNS cerebrovascular ischemia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hydrocephalus | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Neurology - Other (Specify, cerebral edema) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Syncope (fainting) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Thrombosis/thrombus/embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| CD4 Count | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Neutrophils/granulocytes | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Bruising | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastrointestinal - Other | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hematoma | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection - Other | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Kidney | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Opportunistic infection associated with >=Grade 2 Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Glucose, serum-high (hyperglycemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Sodium, serum-low (hyponatremia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Left-sided | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| CNS cerebrovascular ischemia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hydrocephalus | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Mood alteration - Depression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Neurology - Other | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Pyramidal tract dysfunction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Syncope (fainting) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Pain - Head/headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Thrombosis/thrombus/embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |