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 @ 4:18 AM
Ignite Modification Date: 2025-12-26 @ 3:19 AM
NCT ID: NCT01694420
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01694420
Study Brief: Treatment of Acute HIV Infection With Quad Fixed-dose Combination (FDC) Tablet
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Quad FDC FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks (FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment None None 0 33 22 33 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia None Blood and lymphatic system disorders CTCAE version 4 View
Anxiety None Psychiatric disorders CTCAE version 4 View
Chest wall injury None Injury, poisoning and procedural complications CTCAE version 4 View
Constipation None Gastrointestinal disorders CTCAE version 4 View
Decreased appetite None General disorders CTCAE version 4 View
Decreased comprehension None Nervous system disorders CTCAE version 4 View
Decreased neutrophils None Blood and lymphatic system disorders CTCAE version 4 View
Diarrhea None Gastrointestinal disorders CTCAE version 4 View
Disseminated itching None Skin and subcutaneous tissue disorders CTCAE version 4 View
Dizziness None Nervous system disorders CTCAE version 4 View
Dry mouth None General disorders CTCAE version 4 View
Elevated ALT None Hepatobiliary disorders CTCAE version 4 View
Elevated AST None Hepatobiliary disorders CTCAE version 4 View
Elevated BP during leukapheresis None Surgical and medical procedures CTCAE version 4 View
Elevated creatinine None Renal and urinary disorders CTCAE version 4 View
Elevated lipase None Hepatobiliary disorders CTCAE version 4 View
Elevated cholesterol None Endocrine disorders CTCAE version 4 View
Fatigue None General disorders CTCAE version 4 View
Feeling of air stuck in throat None General disorders CTCAE version 4 View
Flatulence None Gastrointestinal disorders CTCAE version 4 View
Headache None Nervous system disorders CTCAE version 4 View
Hot flashes None General disorders CTCAE version 4 View
Hypertriglyceridemia None Metabolism and nutrition disorders CTCAE version 4 View
Hypothyroidism None Endocrine disorders CTCAE version 4 View
Increased appetite None Gastrointestinal disorders CTCAE version 4 View
Alteration in taste None General disorders CTCAE version 4 View
Nausea None Gastrointestinal disorders CTCAE version 4 View
Night sweats None General disorders CTCAE version 4 View
Proteinuria None Renal and urinary disorders CTCAE version 4 View
Rash None Skin and subcutaneous tissue disorders CTCAE version 4 View
Shigella colitis None Gastrointestinal disorders CTCAE version 4 View
Short term memory loss None Nervous system disorders CTCAE version 4 View
stomach cramping None Gastrointestinal disorders CTCAE version 4 View
thigh weakness None General disorders CTCAE version 4 View
thinning hair None Skin and subcutaneous tissue disorders CTCAE version 4 View
Tingling around lips during leukaphersis None Surgical and medical procedures CTCAE version 4 View
Weight loss None General disorders CTCAE version 4 View
Vomiting None Gastrointestinal disorders CTCAE version 4 View