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 @ 5:20 PM
Ignite Modification Date: 2025-12-26 @ 5:20 PM
NCT ID: NCT02431806
Description: Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
Frequency Threshold: 5
Time Frame: First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Study: NCT02431806
Study Brief: Safety and Efficacy of Levomilnacipran ER in Adolescent Participants 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
Placebo Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator. 0 None 0 141 33 141 View
Levomilnacipran 40 mg/Day Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind. 0 None 2 134 54 134 View
Levomilnacipran 80 mg/Day Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind. 0 None 0 138 63 138 View
Fluoxetine 20 mg/Day Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind. 0 None 4 134 41 134 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA : 22.0 View
Intentional overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA : 22.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA : 22.0 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA : 22.0 View
Faecaloma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA : 22.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA : 22.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA : 22.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA : 22.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA : 22.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA : 22.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA : 22.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA : 22.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA : 22.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA : 22.0 View