Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:53 AM
Ignite Modification Date: 2025-12-26 @ 3:54 AM
NCT ID: NCT00414518
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00414518
Study Brief: Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm A Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm\^3 or higher. When CD4 count is less than 350 mm\^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed. None None 1 7 3 7 View
Arm B Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm\^3 at two separate, consecutive measurements None None 1 9 5 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
grade 3 abnormal serum phosphorous level SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
grade 3 headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
low absolute neutrophil count (ANC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Elevated aspartate amino transferase SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
abnormal hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
abnormal phosphorus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
ache/pain/discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
abnormal alanine amino transferase SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
abnormal glucose SYSTEMATIC_ASSESSMENT Endocrine disorders None View
fatigue/malaise SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
abnormal uric acid SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
congestion/effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
abnormal sodium SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
blister/ulcer/lesions SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
chills/rigors/sweats/night sweats SYSTEMATIC_ASSESSMENT Infections and infestations None View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abnormal fasting blood sugar SYSTEMATIC_ASSESSMENT Endocrine disorders None View
macules/papules/rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
mucous membrane/skin abnormality SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea and vomiting/vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
weakness SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View