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 @ 1:06 AM
Ignite Modification Date: 2025-12-25 @ 11:18 PM
NCT ID: NCT00849693
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00849693
Study Brief: A Study in the Treatment of Children and Adolescents With Major Depressive Disorder
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 60 mg - Acute Duloxetine 60 mg, orally, once daily for 10 weeks None None 4 108 76 108 View
Duloxetine 30 mg - Acute Duloxetine 30 mg, orally, once daily for 10 weeks None None 2 116 66 116 View
Fluoxetine 20 mg - Acute Fluoxetine 20 mg, orally, once daily for 10 weeks None None 6 117 69 117 View
Duloxetine 60 mg - Extension Duloxetine 60-120 mg , orally, once daily for 6 months None None 3 73 49 73 View
Fluoxetine 20 mg - Extension Fluoxetine 20-40 mg, orally, once daily for 6 months None None 1 84 45 84 View
Placebo/Duloxetine - Extension Duloxetine 60-120 mg , orally, once daily for 6 months None None 4 82 52 82 View
Placebo - Acute Placebo capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks None None 2 122 71 122 View
Duloxetine 30 mg - Extension Duloxetine 60-120 mg , orally, once daily for 6 months One participant who had completed the acute treatment phase and didn't go into the extension phase, was accidentally dispensed the drug at the last visit of the acute treatment phase. Based on intent-to-treat principal, this participant was included in the extension phase analyses for adverse events (AEs; resulting in one more participant being analyzed for AEs than the number of participants who started the extension phase \[see Participant Flow section\]). None None 2 81 46 81 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Irritable bowel syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Tuberculosis of peripheral lymph nodes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Intentional overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Abnormal behaviour SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Depressive symptom SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Homicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Self injurious behaviour SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Stevens-Johnson syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Incorrect dose administered SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View