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 @ 2:09 AM
Ignite Modification Date: 2025-12-26 @ 12:36 AM
NCT ID: NCT04096560
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold: 5
Time Frame: First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
Study: NCT04096560
Study Brief: A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part A: TAK-994 180 mg TAK-994 180 mg, orally, BID for 28 days, in participants with NT1. 0 None 0 8 7 8 View
Part B: Placebo TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1. 0 None 0 17 4 17 View
Part B: TAK-994 30 mg TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1. 0 None 0 17 13 17 View
Part B: TAK-994 90 mg TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1. 0 None 0 20 17 20 View
Part B: TAK-994 180 mg TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1. 0 None 1 19 14 19 View
Part A: Placebo TAK-994 placebo-matching tablets, orally, BID for 28 days, in participants with NT1. 0 None 0 7 2 7 View
Part A: TAK-994 120 mg TAK-994 120 mg, orally, BID for 28 days, in participants with NT1. 0 None 0 7 6 7 View
Part C: TAK-994 180 mg TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1 0 None 0 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hepatitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Middle insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24 View
Muscle twitching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24 View
Tension headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Abdominal mass SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Blepharospasm SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Ex-tobacco user SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 24 View
Faeces discoloured SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Faeces hard SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Feeling jittery SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Giardiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Glutamate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Granulocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24 View
Hypertonic bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Hypervigilance SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Initial insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Papule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Polyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Puncture site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24 View
Salivary hypersecretion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24 View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Vaccination complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24 View
Vulvovaginal inflammation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Pleomorphic adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Blood pressure diastolic increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood pressure systolic increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Bacterial disease carrier SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View