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 @ 6:36 PM
Ignite Modification Date: 2025-12-25 @ 4:07 PM
NCT ID: NCT03108157
Description: All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.
Frequency Threshold: 1
Time Frame: Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization.
Study: NCT03108157
Study Brief: Endometrial Scratch Effect on Pregnancy Rates in Patients Undergoing Egg-donation IVF
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GROUP A: Intervention Group Patients will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before the embryo transfer and then they will follow the conventional preparation protocol to receive embryos coming from an egg donation treatment. 0 None 0 161 36 161 View
GROUP B: no Intervention Group Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment. 0 None 0 172 47 172 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Miscarriage SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Ectopic pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Vanishing twin SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Placentation abnormalities SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Intrauterine growth restriction SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Preterm delivery threat SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Premature membrane rupture SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Gestational diabetes SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Pre-eclampsia SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Gestational cholestasis SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Abortion SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Preterm delivery SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
2nd twin stillbirth SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View