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 @ 12:50 PM
Ignite Modification Date: 2025-12-25 @ 12:15 PM
NCT ID: NCT00425061
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 0
Time Frame: None
Study: NCT00425061
Study Brief: Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
IMA-638 0.6 mg/kg: Stage 1 IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1. None None 1 17 12 17 View
IMA-638 2 mg/kg: Stage-1 IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1. None None 2 16 11 16 View
Placebo: Stage 1 Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1. None None 1 16 10 16 View
IMA-638 200 mg: Stage 2 and 3 IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3. None None 2 45 27 45 View
IMA-638 75 mg: Stage 3 IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3. None None 0 4 1 4 View
Placebo: Stage 2 and 3 Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3. None None 0 45 26 45 View
IMA-638 0.2 mg/kg: Stage 1 IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1. None None 0 16 13 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Deafness unilateral NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Staphylococcal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Deafness unilateral NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Ear congestion NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Ear discomfort NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Tympanic membrane scarring NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eyelids pruritus NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Ocular hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Visual disturbance NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Food poisoning NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastric ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site bruising NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site induration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site urticaria NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pitting oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Drug hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Abdominal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Conjunctivitis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Helicobacter infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Laryngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oropharyngeal candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ankle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Back injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Epicondylitis NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Excoriation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint dislocation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Ligament rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Muscle strain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Post procedural complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Skeletal injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Lipase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Plantar fasciitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Tendonitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sinus headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Nicotine dependence NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Amenorrhoea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Menorrhagia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Foreign body aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngeal leukoplakia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinitis seasonal NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Throat irritation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Cold sweat NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Ingrowing nail NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rosacea NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Scar NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Swelling face NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Diastolic hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Rash papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash pustular NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Joint range of motion decreased NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Rhabdomyolysis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Rotator cuff syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Tension headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Alcohol abuse NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal polyps NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Gout NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood amylase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood creatine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View