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: 2025-12-26 @ 10:58 AM
Ignite Modification Date: 2025-12-26 @ 10:58 AM
NCT ID: NCT00637806
Description: None
Frequency Threshold: 0
Time Frame: Approximately 98 days (from informed consent through 7 days following the last dose of study drug or up until the last protocol-specified study visit, whichever occurred later)
Study: NCT00637806
Study Brief: Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DB MA-CS 550 mg/Day MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase None None 0 2 1 2 View
DB MA-CS 300 mg/Day MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase None None 0 0 0 0 View
DB Placebo Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase None None 1 2 2 2 View
OL MA-CS 550 mg/Day MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week OL extension phase None None 1 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Accident at home NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.1 View
Rib fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.1 View
Concussion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.1 View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 8.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.1 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 8.1 View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 8.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.1 View