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 @ 11:29 PM
Ignite Modification Date: 2025-12-25 @ 9:16 PM
NCT ID: NCT01778556
Description: None
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT01778556
Study Brief: Short-term Effects of Leptin in People With Lipodystrophy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention 1 ( 5 Days) : On-Leptin Studied for 5 days while taking metreleptin Metreleptin: Recombinant analog of the human hormone, leptin 0 None 0 8 0 8 View
Intervention 1 ( 14 Days): On-Leptin Studied for 14 days during metreleptin withdrawal after Intervention 1 ( 5 days) : On-Leptin Metreleptin: Recombinant analog of the human hormone, leptin 0 None 0 8 0 8 View
Intervention 1 (5 Days) : Leptin Naive Studied for 5 days without taking metreleptin. Metreleptin: Recombinant analog of the human hormone, leptin 0 None 0 15 0 15 View
Intervention 2 (14 Days): Leptin Naive Studied for 14 days while taking metreleptin after the intervention 1 (5 days) : Leptin Naive Metreleptin: Recombinant analog of the human hormone, leptin 0 None 1 15 2 15 View
Long-term Follow-up (6 Months): Leptin Naive Studied for 6 months while taking metreleptin after intervention 2 (14 days): Leptin Naive Metreleptin: Recombinant analog of the human hormone, leptin 0 None 2 15 4 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
abdominal pain of unknown etiology NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
angioedema secondary to angiotensin- converting enzyme inhibitor use NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
anemia secondary to menorrhagia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
weight loss NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hair loss NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
hypoglycemia (in a subject treated with insulin) NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
injection site reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
menorrhagia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View