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 @ 1:12 AM
Ignite Modification Date: 2025-12-25 @ 11:22 PM
NCT ID: NCT03840993
Description: None
Frequency Threshold: 0
Time Frame: Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
Study: NCT03840993
Study Brief: Safety and Efficacy Study of MT-2990 in Women With Endometriosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo, over 16 weeks 0 None 0 39 22 39 View
MT-2990 MT-2990, over 16 weeks 0 None 1 37 23 37 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abortion induced SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Axillary pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Catheter site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Infusion site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Injection site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Bacterial vaginosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Corona virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Vulvovaginal mycotic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Coronavirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Urine analysis abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Ageusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Anosmia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Clonic convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Meralgia paraesthetica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Mood swings SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Urge incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Breast cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.1 View
Breast tenderness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.1 View
Dysfunctional uterine bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.1 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.1 View
Fibrocystic breast disease SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.1 View
Hydrosalpinx SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.1 View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.1 View
Nipple pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.1 View
Vulvovaginal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Photosensitivity reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View