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 @ 1:06 PM
Ignite Modification Date: 2025-12-25 @ 12:21 PM
NCT ID: NCT00101361
Description: Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.
Frequency Threshold: 5
Time Frame: years, 5 months
Study: NCT00101361
Study Brief: Oxandrolone to Heal Pressure Ulcers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
1 Oxandrolone oxandrolone - two 5mg capsules twice daily None None 9 108 95 108 View
2 Placebo placebo - two capsules twice daily None None 16 104 85 104 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
oral cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MeDRA 13 View
elective bladder stone removal SYSTEMATIC_ASSESSMENT Surgical and medical procedures MeDRA 13 View
myocutaneous flap surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MeDRA 13 View
death SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MeDRA 13 View
death SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 13 View
small bowel obstruction, renal failure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 13 View
death SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MeDRA 13 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MeDRA 13 View
elevated liver enzyme levels SYSTEMATIC_ASSESSMENT Investigations MeDRA 13 View
nausea / vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 13 View
osteomylitis SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 13 View
urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 13 View
constipation or diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 13 View
fever SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MeDRA 13 View
infection SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 13 View
non-Target Pressure Ulcer (TPU) skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeDRA 13 View
pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 13 View
skin rash / complication SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeDRA 13 View