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 @ 1:14 PM
Ignite Modification Date: 2025-12-25 @ 12:24 PM
NCT ID: NCT01417195
Description: None
Frequency Threshold: 2
Time Frame: Day 1 up to Day 20
Study: NCT01417195
Study Brief: Menopur Mixed Protocol
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Menopur and Bravelle Combination The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20. None None 0 60 29 60 View
Menopur Alone The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20. None None 0 62 30 62 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.0) View
Post procedural discomfort SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (14.0) View
Procedural nausea SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (14.0) View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (14.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.0) View
Ovarian hyperstimulation syndrome SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (14.0) View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (14.0) View