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 @ 2:49 AM
Ignite Modification Date: 2025-12-26 @ 1:30 AM
NCT ID: NCT00560833
Description: None
Frequency Threshold: 5
Time Frame: Non-serious adverse events were collected up to 7 days after the last dose of study drug; serious adverse events were collected for up to 30 days after the last dose of study drug.
Study: NCT00560833
Study Brief: Dose-Finding Safety and Efficacy Trial of Org50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (46101/P06459/MK-8265-012)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Esmirtazapine 9 mg Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks None None 2 155 102 155 View
Esmirtazapine 18mg Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks None None 0 155 123 155 View
Esmirtazapine 4.5 mg Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks None None 3 160 99 160 View
Placebo Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks None None 2 317 128 317 View
Esmirtazapine 2.25 mg Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks None None 1 154 93 154 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis perforated SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.1 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.1 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.1 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.1 View
Conversion disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.1 View
Vaginal lesion SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9.1 View
Scar SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.1 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9.1 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.1 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.1 View