Adverse Events Module

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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 @ 12:15 PM
Ignite Modification Date: 2025-12-25 @ 12:01 PM
NCT ID: NCT01030861
Description: CTCAE
Frequency Threshold: 0
Time Frame: Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
Study: NCT01030861
Study Brief: Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Teplizumab Intravenous infusions of teplizumab given for 14 consecutive days. Each infusion takes about 30 minutes and is followed by a 2 hour observation period. Teplizumab: intravenous infusions 0 None 8 44 43 44 View
Placebo Infusion Intravenous infusion of placebo (saline) will be given for 14 consecutive days. Infusions will take approximately 30 minutes and will be followed by a two hour observation period. Placebo infusion: Placebo for Teplizumab 0 None 1 32 23 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Infection - Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Infection with normal ANC or Grade 1 or 2 neutrophils SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection with unknown ANC SYSTEMATIC_ASSESSMENT Infections and infestations None View
Obstruction, GI SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chest Wall Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Obstruction, GU SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasal cavity/paranasal sinus reactions SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cognitive Disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy: motor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Breast function/lactation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Bruising (in absence of Grade 3 or 4 thrombocytopenia) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cardiac Arrhythmia - Other (Specify in Event Details) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cholesterol, serum-high (hypercholesteremia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dental: teeth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dental: teeth development SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Eyelid dysfunction SYSTEMATIC_ASSESSMENT Eye disorders None View
Elevated Bilirubin SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nail changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Neuropathy: sensory SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Otitis, middle ear (non-infectious) SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Personality/behavioral SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Phlebitis (including superficial thrombosis) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Syncope (fainting) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Allergic reaction/hypersensitivity (including drug fever) SYSTEMATIC_ASSESSMENT Immune system disorders None View
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) SYSTEMATIC_ASSESSMENT Immune system disorders None View
Alpha-Gal Allergy SYSTEMATIC_ASSESSMENT Immune system disorders None View
ALT, SGPT (serum glutamic pyruvic transaminase) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
AST, SGOT(serum glutamic oxaloacetic transaminase) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bronchospasm, wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cytokine release syndrome/acute infusion reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Dental: periodontal disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Folliculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea (shortness of breath) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue (asthenia, lethargy, malaise) SYSTEMATIC_ASSESSMENT General disorders None View
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) SYSTEMATIC_ASSESSMENT General disorders None View
Flu-like syndrome SYSTEMATIC_ASSESSMENT General disorders None View
Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Stomach Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Heartburn/dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Vitreous hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Infection with Normal ANC SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection with unknown ANC SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injection site reaction/extravasation changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Leukocytes (total WBC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocytes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Mood alteration SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Joint Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myositis (inflammation/damage of muscle) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neutrophils/granulocytes (ANC/AGC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Obstruction, GI SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ocular surface disease SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pneumonitis/pulmonary infiltrates SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritus/itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pulmonary/Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash/desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash: hand-foot skin reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Kidney Stones SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Thyroid function, low (hypothyroidism) SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Urticaria (hives, welts, wheals) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight gain SYSTEMATIC_ASSESSMENT General disorders None View
Bilirubin (hyperbilirubinemia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View