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 @ 2:33 PM
Ignite Modification Date: 2025-12-25 @ 1:05 PM
NCT ID: NCT00129259
Description: This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Frequency Threshold: 5
Time Frame: From the initiation of study treatment through month 24 visit (i.e., throughout the duration of the study)
Study: NCT00129259
Study Brief: Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Anti-CD3 mAb Plus Diabetes Standard of Care Treatment Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 \[Cycle 1\] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)\[Cycle 2\]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team. None None 10 52 52 52 View
Diabetes Standard of Care Treatment Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team. None None 1 25 23 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Splenic rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Skull fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Diarrhoea infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Goitre SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 11.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 11.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Catheter site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Infusion site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.1 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.1 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.1 View
Acne pustular SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Conjunctivitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Diarrhoea infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Skin papilloma SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Tinea infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Excoriation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Joint sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
CD4 lymphocytes decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Glycosylated haemoglobin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Haematocrit decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Ketonuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.1 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Tonsillar hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Upper respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Lipohypertrophy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Rash generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View