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: 2025-12-25 @ 2:13 AM
Ignite Modification Date: 2025-12-26 @ 12:41 AM
NCT ID: NCT01077960
Description: Adverse events occurring during study treatment are reported
Frequency Threshold: 5
Time Frame: Adverse events were to be reported and collected on an ongoing basis from the day of written informed consent (baseline) until 4 weeks after the last investigational product administration.
Study: NCT01077960
Study Brief: Safety and Efficacy Study of Serostim® Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Serostim Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment \[Serono Study 24380\] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day) None None 2 126 89 126 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (8.0) View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (8.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA (8.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (8.0) View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (8.0) View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (8.0) View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (8.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (8.0) View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (8.0) View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (8.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (8.0) View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (8.0) View