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 @ 12:09 PM
Ignite Modification Date: 2025-12-25 @ 11:59 AM
NCT ID: NCT04150861
Description: A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
Frequency Threshold: 0
Time Frame: From signed informed consent until the end-of-trial visit (Day 28)
Study: NCT04150861
Study Brief: Rekovelle PK Trial in Chinese Women
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Follitropin Delta (FE 999049) 12 μg Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period. 0 None 0 8 5 8 View
Follitropin Delta (FE 999049) 18 μg Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period. 0 None 0 8 4 8 View
Follitropin Delta (FE 999049) 24 μg Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period. 0 None 0 8 3 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (22.0) View
Procedural dizziness SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (22.0) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (22.0) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (22.0) View
Blood urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA (22.0) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (22.0) View
Red blood cells urine positive SYSTEMATIC_ASSESSMENT Investigations MedDRA (22.0) View
Smear cervix abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA (22.0) View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (22.0) View
Poor quality sleep SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (22.0) View
Cervical dysplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (22.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (22.0) View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (22.0) View