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: 2025-12-26 @ 12:18 PM
Ignite Modification Date: 2025-12-26 @ 12:18 PM
NCT ID: NCT01180400
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT01180400
Study Brief: A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients 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
TC-5214 Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID None None 1 147 83 147 View
Placebo Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID None None 2 146 65 146 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Uterine Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.1 View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 14.1 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Orthostatic Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 14.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Increased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.1 View
Abdominal distention SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View