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 @ 4:18 PM
Ignite Modification Date: 2025-12-25 @ 2:15 PM
NCT ID: NCT01051466
Description: None
Frequency Threshold: 3
Time Frame: None
Study: NCT01051466
Study Brief: A Study of the Neurobiology of Depression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Duloxetine Duloxetine: Participants with major depressive disorder (MDD) received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. None None 1 32 32 32 View
Healthy Participants Healthy participants: Participants were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug. None None 0 28 11 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Retinal pigment epitheliopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Microcytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Motion sickness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 15.1 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Epigastric discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Irritable bowel syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Salivary hypersecretion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Sluggishness SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Allergy to animal SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.1 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.1 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Procedural dizziness SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Tendon injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Tooth fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Gastric ph decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Food craving SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Joint stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Muscle twitching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Myoclonus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Nervous system disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
White matter lesion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Abnormal dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Anorgasmia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Bruxism SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Libido decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Obsessive-compulsive disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Micturition disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Urinary hesitation SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Ejaculation delayed SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Ejaculation disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Dry throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Nasal polyps SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Yawning SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View