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 @ 12:03 AM
Ignite Modification Date: 2025-12-25 @ 10:01 PM
NCT ID: NCT01906658
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01906658
Study Brief: A Study to Explore the Safety and Tolerability of Acthar in Patients With Amyotrophic Lateral Sclerosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Acthar 80 U (1.0 mL) SC Twice Weekly Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks None None 2 11 11 11 View
Acthar 24 U (0.3 mL) SC Daily Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks None None 3 11 11 11 View
Acthar 56 U (0.7 mL) SC Twice Weekly Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks None None 1 10 9 10 View
Acthar 16 U (0.2 mL) SC Daily Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks None None 1 11 11 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory arrest None Respiratory, thoracic and mediastinal disorders None View
Seizures None Nervous system disorders None View
Atelectasis None Respiratory, thoracic and mediastinal disorders None View
Respiratory failure None Respiratory, thoracic and mediastinal disorders None View
Hypokalaemia None Metabolism and nutrition disorders None View
Feeding tube complication None Injury, poisoning and procedural complications None View
Supraventricular tachycardia None Cardiac disorders None View
Gastrointestinal haemorrhage None Gastrointestinal disorders None View
Pneumonia None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Edema, peripheral None General disorders None View
Headache None Nervous system disorders None View
Muscle spasms None Musculoskeletal and connective tissue disorders None View
Anxiety None Psychiatric disorders None View
Edema None General disorders None View
Salivary hypersecretion None Gastrointestinal disorders None View
Dizziness None Nervous system disorders None View
Vision blurred None Eye disorders None View
Diarrhea None Gastrointestinal disorders None View
Muscle atrophy None Musculoskeletal and connective tissue disorders None View
Muscular weakness None Musculoskeletal and connective tissue disorders None View
Fall None Injury, poisoning and procedural complications None View
Asthenia None General disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View