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 @ 9:21 PM
Ignite Modification Date: 2025-12-25 @ 7:07 PM
NCT ID: NCT04095104
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Study: NCT04095104
Study Brief: Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Phentermine & Topiramate Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care. 0 None 1 6 6 6 View
Placebo Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care. 0 None 0 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospital admission SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Restlessness SYSTEMATIC_ASSESSMENT General disorders None View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Difficulty with sleep SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Paresthesias SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Difficulty with concentration/attention SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea/Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Change in Taste SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eye discomfort SYSTEMATIC_ASSESSMENT Eye disorders None View
Flushing SYSTEMATIC_ASSESSMENT General disorders None View
Memory problems SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Menstruation change SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mental fogginess SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Word finding difficulties SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Back, side, and/or groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
COVID disease SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blurry vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Decreased sweating SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Myalgias SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Esophageal fullness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Finger fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Inability to cool down SYSTEMATIC_ASSESSMENT General disorders None View
Swelling in arms, legs, face SYSTEMATIC_ASSESSMENT General disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vaginal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Depression Score by CES-D that increased from normal to elevated (>=20) on study SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidality screen (CSSRS) positivity on study SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Low bicarbonate (<20mmol/L) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Low potassium (<3.5mmol/L) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Elevated creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Positive urine pregnancy test SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Elevated systolic blood pressure (>=120mmHg) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Elevated diastolic BP (>=80mmHg) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Elevated heart rate (>=100 beats per minute) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Elevated temperature (measured) SYSTEMATIC_ASSESSMENT General disorders None View