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 @ 9:15 PM
Ignite Modification Date: 2025-12-25 @ 7:04 PM
NCT ID: NCT04329104
Description: None
Frequency Threshold: 0
Time Frame: Up to 24 weeks
Study: NCT04329104
Study Brief: Safety and Efficacy of CIS43LS Anti-malaria mAb in Mali
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0. 0 None 0 6 4 6 View
Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0. 0 None 0 6 5 6 View
Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0. 0 None 0 6 4 6 View
Efficacy Study: Arm 1: 10 mg/kg of CIS43LS Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0. 1 None 1 110 49 110 View
Efficacy Study: Arm 2: 40 mg/kg of CIS43LS Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0. 0 None 1 110 40 110 View
Efficacy Study: Arm 3: Placebo Participants receive placebo as one time intravenous infusion on Day 0. 0 None 2 110 61 110 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Inguinal Hernia Repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Umbilical Hernia Repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hypersplenism SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
White Blood Cell Count Increased SYSTEMATIC_ASSESSMENT Investigations None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphadenitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Eye Swelling SYSTEMATIC_ASSESSMENT Eye disorders None View
Visual Acuity Reduced SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain Lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dental Caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Food Poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric Disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gingival Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gingival Ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mouth Ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Strangulated Umbilical Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Umbilical Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Chest Discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Hernia Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Acarodermatitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dysentery SYSTEMATIC_ASSESSMENT Infections and infestations None View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Genital Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Genitourinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes Dermatitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Localised Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Malaria SYSTEMATIC_ASSESSMENT Infections and infestations None View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Salmonellosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tinea Pedis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tinea Versicolour SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Typhus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Limb Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin Abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood Pressure Diastolic Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood Pressure Diastolic Increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood Pressure Increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood Pressure Systolic Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood Pressure Systolic Increased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
White Blood Cell Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Decreased Appetite 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
Intervertebral Disc Protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Torticollis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Head Discomfort SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Breast Pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal Discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dermatitis Contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tooth Extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Venipuncture SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View