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: 2025-12-25 @ 12:14 AM
Ignite Modification Date: 2025-12-25 @ 10:16 PM
NCT ID: NCT00965458
Description: None
Frequency Threshold: 5
Time Frame: Enrollment through participant's last visit, up to Week 104
Study: NCT00965458
Study Brief: Inducing Remission in Type 1 Diabetes With Alefacept
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Alefacept Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment None None 1 33 33 33 View
Placebo Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment None None 0 16 16 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Cerumen impaction SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.1 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 13.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Episcleritis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Allergy to arthropod bite SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.1 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.1 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Rash pustular SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Staphylococcal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Tinea pedis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Excoriation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Nail avulsion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Subcutaneous haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
CD4 lymphocytes decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Cardiac murmur SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Low density lipoprotein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Neutrophil count abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Muscle twitching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Muscle contractions involuntary SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Sinus headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Laryngeal inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Paranasal sinus hypersecretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pharyngeal erythema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Tonsillar hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Upper respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Lipohypertrophy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Skin discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View