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 @ 11:18 PM
Ignite Modification Date: 2025-12-25 @ 8:58 PM
NCT ID: NCT00257556
Description: The 'all patients treated' population is the same as the safety population in this study.
Frequency Threshold: 5
Time Frame: None
Study: NCT00257556
Study Brief: A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Menotrophin Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG) None None 4 37 18 37 View
Follitropin Alfa A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)). None None 9 39 21 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Abdominal Pain Lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Abortion Spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 7.1 View
Abortion Imminent SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 7.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 7.1 View
Ovarian Hyperstimulation Syndrome SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 7.1 View
Uterine Haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 7.1 View
Vaginal Haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 7.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Abdominal Pain Lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Injection Site Bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Injection Site Haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Injection Site Pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Injection Site Rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Injection Site Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 7.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 7.1 View
Breast Tenderness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 7.1 View
Ovarian Hyperstimulation Syndrome SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 7.1 View
Vaginal Haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 7.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 7.1 View
Skin Reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 7.1 View