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 @ 1:18 AM
Ignite Modification Date: 2025-12-25 @ 11:26 PM
NCT ID: NCT01744093
Description: Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.
Frequency Threshold: 0
Time Frame: 24 Weeks
Study: NCT01744093
Study Brief: Doxycycline for COPD in HIV-Infected Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo (Sugar Pill) Placebo (sugar pill) x 100 mg BID (orally) for 24 weeks. 0 None 0 8 6 8 View
Doxycycline Doxycycline x 100 mg BID (orally) for 24 weeks. 0 None 0 16 13 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Oral thrush SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hemoglobin drop SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Mouth lesions SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Excoriated lesions on arms SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Intermittent diarrhea for 4-5 wk SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Scattered maculopapular rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemoptysis (mild) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Low absolute neutrophil count SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pain on right side SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tiredness SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Elevated Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View