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 @ 12:10 AM
Ignite Modification Date: 2025-12-25 @ 10:10 PM
NCT ID: NCT01650558
Description: None
Frequency Threshold: 0
Time Frame: 2 to 5.5 years
Study: NCT01650558
Study Brief: Daily Trimethoprim-sulfamethoxazole or Weekly Chloroquine Among Adults on ART in Malawi
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard of Care Trimethoprim Sulfamethoxazo (TS) Prophylaxis Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole). 10 None 72 500 488 500 View
Chloroquine (CQ) Prophylaxis Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg. 6 None 99 500 483 500 View
Discontinuation of Standard of Care (Control Arm) Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis. 8 None 116 499 488 499 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infections SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pregnancy, puerperium and perinatal SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Nervous SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Injuries SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Neoplasms SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Surgical and medical SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
General SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Reproductive system SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Blood SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Psychiatric SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vascular SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Metabolism SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Endocrine SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Hepatobiliary SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Renal SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infections SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
General SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Investigations SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Blood SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Nervous SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Reproductive system SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Injuries SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Vascular SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Pregnancy, puerperium and perinatal SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Metabolism SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Ear and labyrinth SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Neoplasms SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Renal SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Psychiatric SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Surgical and medical SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Hepatobiliary SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Endocrine SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Congenital, familial and genetic SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View