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 @ 5:38 PM
Ignite Modification Date: 2025-12-25 @ 3:08 PM
NCT ID: NCT02458768
Description: Among the 112 subjects randomized in this clinical study, one subject did not receive Investigational Product in the Menopur® Inj. group. This subject did not included in the Safety set. So total 111 subjects were included in the Safety set.
Frequency Threshold: 5
Time Frame: None
Study: NCT02458768
Study Brief: Multicenter, Randomized, Open Label, Parallel Study to Evaluate the Efficacy & Safety of IVF-M HP Inj. vs. Menopur® Inj.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
IVF-M HP Inj. Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection. Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). IVF-M HP Inj. None None 0 57 13 57 View
Menopur® Inj. Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection. Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). Menopur® Inj. None None 1 54 16 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ovarian hyperstimulation syndrome None Reproductive system and breast disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension None Gastrointestinal disorders None View
Dizziness None Nervous system disorders None View
Headache None Nervous system disorders None View
Abdominal discomfort None Gastrointestinal disorders None View
Abdominal pain None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Lethargy None General disorders None View
Vaginal haemorrhage None Reproductive system and breast disorders None View