Adverse Events Module

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 @ 6:31 PM
Ignite Modification Date: 2025-12-25 @ 4:02 PM
NCT ID: NCT02455557
Description: None
Frequency Threshold: 0
Time Frame: Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Study: NCT02455557
Study Brief: SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (SurVaxM, Temozolomide) Patients receive the first priming dose of SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC within 7-28 days after completion of chemoradiation. Treatment repeats every 2 weeks for a total of 4 doses in the vaccine priming phase and then every 12 weeks during the adjuvant phase in the absence of disease progression or unacceptable toxicity. Patients also receive standard adjuvant temozolomide PO or IV on days 1-5. Treatment repeats every 28 days for 6 courses or more (at the discretion of the investigator) in the absence of disease progression or unacceptable toxicity. Patients may then receive maintenance SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC every 12 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Montanide ISA 51 VG: Given SC Sargramostim: Given SC SVN53-67/M57-KLH Peptide Vaccine: Given SC Temozolomide: Given PO or IV 36 None 22 66 65 66 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Colonic abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Meningitis aseptic SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Haemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Chest tube insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Craniotomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hip surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Thoracotomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Enterovesical fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders None View
Injection site rash SYSTEMATIC_ASSESSMENT General disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Haemoglobin urine present SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count increased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations None View
Urine ketone body present SYSTEMATIC_ASSESSMENT Investigations None View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations None View
Weight increased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Partial seizures SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mental impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oesophageal spasm SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Retching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Application site discolouration SYSTEMATIC_ASSESSMENT General disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Cyst SYSTEMATIC_ASSESSMENT General disorders None View
Face oedema SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Implant site oedema SYSTEMATIC_ASSESSMENT General disorders None View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders None View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders None View
Injection site discharge SYSTEMATIC_ASSESSMENT General disorders None View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders None View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders None View
Injection site inflammation SYSTEMATIC_ASSESSMENT General disorders None View
Injection site nodule SYSTEMATIC_ASSESSMENT General disorders None View
Injection site infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lyme disease SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Incision site complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood ketone body SYSTEMATIC_ASSESSMENT Investigations None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fasciitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Limb discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Malignant melanoma in situ SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebrospinal fluid leakage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Coordination abnormal SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure like phenomena SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sinus headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Taste disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Affect lability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dysphoria SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hallucination, visual SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Libido decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Mental disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper-airway cough syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Panniculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin hypertrophy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin induration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin mass SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rotator cuff repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral coldness SYSTEMATIC_ASSESSMENT Vascular disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Excessive cerumen production SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Cushingoid SYSTEMATIC_ASSESSMENT Endocrine disorders None View