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 @ 4:35 AM
Ignite Modification Date: 2025-12-26 @ 3:37 AM
NCT ID: NCT03030118
Description: None
Frequency Threshold: 5
Time Frame: Up to 96 weeks.
Study: NCT03030118
Study Brief: Study of Anti-Malarials in Incomplete Lupus Erythematosus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Hydroxychloroquine Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks. Hydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis. 0 None 4 92 83 92 View
Placebo Oral Capsule Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks. Placebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine. 0 None 5 88 85 88 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hospitalization Uterine Fibroids SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hospitalization Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hospitalization Thromboembolic event SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hospitalization Radiculitis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hospitalization Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization Bilateral capsulotomy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hospitalization COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization Cholecystitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hospitalization Mastectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Flu like symptoms SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
COVID-19 Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal infection SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View