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 @ 6:56 PM
Ignite Modification Date: 2025-12-25 @ 4:29 PM
NCT ID: NCT00844857
Description: Adverse events were reported for all randomized participants who took at least 1 dose of study drug, excluding 2 GCP noncompliant sites.
Frequency Threshold: 5
Time Frame: None
Study: NCT00844857
Study Brief: A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar 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
Olanzapine/Fluoxetine Combination OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks. None None 9 170 125 170 View
Placebo Matched placebo capsule administered orally once daily for 8 weeks. None None 6 85 49 85 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaphylaxis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 14.1 View
Pyoderma SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Aggression aggravated SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Bipolar affective disorder aggravated SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Depression worsened SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Self injurious behavior SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Ovulation disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 14.1 View
Homicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Psychosis aggravated SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Triglyceride increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.1 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.1 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.1 View
Drowsiness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View