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: NCT00883493
Description: None
Frequency Threshold: 4
Time Frame: None
Study: NCT00883493
Study Brief: Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in 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
Quetiapine XR Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. None None 5 212 147 212 View
Quatiapine XR + Lithium Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day. None None 5 209 149 209 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization due to suicide risk SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Somnolance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.0 View
Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Exacerbation of symptoms SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry mouth SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Somnolance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Increased appetite SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Weight gain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View