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 @ 4:27 AM
Ignite Modification Date: 2025-12-26 @ 3:31 AM
NCT ID: NCT00129220
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT00129220
Study Brief: Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I 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
Olanzapine olanzapine: 5 to 20 mg per day for 6 weeks None None 1 105 78 105 View
Haloperidol haloperidol: 2.5 to 10 mg per day for 6 weeks None None 0 20 14 20 View
Placebo placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks None None 3 96 64 96 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bipolar I disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Mania SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Status epilepticus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthenopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Salivary hypersecretion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Hunger SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Subcutaneous haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Blood pressure decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Electrocardiogram qt prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Glycosylated haemoglobin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dystonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Depressive symptom SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Mania SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View