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 @ 4:22 PM
Ignite Modification Date: 2025-12-25 @ 2:17 PM
NCT ID: NCT01312766
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01312766
Study Brief: Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
hMG-IBSA New hMG preparation. Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age. None None 5 135 46 135 View
Menopur Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age. None None 8 135 42 135 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vestibular disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
peritoneal heamorrage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headacje SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abortion Incomplete SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Abortion Missed SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Abortion threatened SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Ectopic pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Hyperemesis gravidarum SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Imminent abortion SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
OHSS SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Ovarina torsion SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal haemorrage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hot flushes SYSTEMATIC_ASSESSMENT Vascular disorders None View