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: 2025-12-24 @ 6:34 PM
Ignite Modification Date: 2025-12-25 @ 4:04 PM
NCT ID: NCT00638157
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00638157
Study Brief: Phase 4 Efficacy and Safety Study of Cubicin® With and Without Combination Therapy in S. Aureus Infective Endocarditis (SAIE)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Daptomycin Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a "dummy" infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy. None None 2 10 8 10 View
Daptomycin Plus Gentamicin Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy. None None 5 12 11 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tachycardia None Cardiac disorders None View
Gastrointestinal haemorrhage None Gastrointestinal disorders None View
Arthritis bacterial None Infections and infestations None View
Bacteraemia None Infections and infestations None View
Endocarditis None Infections and infestations None View
Osteomyelitis None Infections and infestations None View
Renal failure None Renal and urinary disorders None View
Haemoptysis None Respiratory, thoracic and mediastinal disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Hypertension None Vascular disorders None View
Septic shock None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pyrexia None General disorders None View
Anaemia None Blood and lymphatic system disorders None View
Splenomegaly None Blood and lymphatic system disorders None View
Hypoacusis None Ear and labyrinth disorders None View
Abnormal sensation in eye None Eye disorders None View
Eye pain None Eye disorders None View
Vision blurred None Eye disorders None View
Constipation None Gastrointestinal disorders None View
Diarrhoea None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Umbilical hernia None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Catheter related complication None General disorders None View
Chest discomfort None General disorders None View
Chills None General disorders None View
Influenza like illness None General disorders None View
Malaise None General disorders None View
Non-cardiac chest pain None General disorders None View
Oedema peripheral None General disorders None View
Bacterial sepsis None Infections and infestations None View
Escherichia urinary tract infection None Infections and infestations None View
Fungal skin infection None Infections and infestations None View
Hepatitis C None Infections and infestations None View
Osteomyelitis None Infections and infestations None View
Paronychia None Infections and infestations None View
Contusion None Injury, poisoning and procedural complications None View
Procedural pain None Injury, poisoning and procedural complications None View
Wound None Injury, poisoning and procedural complications None View
Aspartate aminotransferase increased None Investigations None View
Blood creatine phosphokinase increased None Investigations None View
Blood creatinine increased None Investigations None View
Blood glucose increased None Investigations None View
Cardiac murmur None Investigations None View
Haematocrit decreased None Investigations None View
Haemoglobin decreased None Investigations None View
Hepatic enzyme increased None Investigations None View
Red blood cell count decreased None Investigations None View
White blood cell count increased None Investigations None View
Diabetes mellitus inadequate control None Metabolism and nutrition disorders None View
Hyperkalaemia None Metabolism and nutrition disorders None View
Hyperphosphataemia None Metabolism and nutrition disorders None View
Hypokalaemia None Metabolism and nutrition disorders None View
Hypomagnesaemia None Metabolism and nutrition disorders None View
Muscle spasms None Musculoskeletal and connective tissue disorders None View
Musculoskeletal pain None Musculoskeletal and connective tissue disorders None View
Neck pain None Musculoskeletal and connective tissue disorders None View
Pain in extremity None Musculoskeletal and connective tissue disorders None View
Dysgeusia None Nervous system disorders None View
Headache None Nervous system disorders None View
Somnolence None Nervous system disorders None View
Agitation None Psychiatric disorders None View
Anxiety None Psychiatric disorders None View
Insomnia None Psychiatric disorders None View
Renal impairment None Renal and urinary disorders None View
Urinary incontinence None Renal and urinary disorders None View
Dyspnoea None Respiratory, thoracic and mediastinal disorders None View
Nasal congestion None Respiratory, thoracic and mediastinal disorders None View
Dry skin None Skin and subcutaneous tissue disorders None View
Skin lesion None Skin and subcutaneous tissue disorders None View
Skin ulcer None Skin and subcutaneous tissue disorders None View
Hypertension None Vascular disorders None View
Hypotension None Vascular disorders None View
Phlebitis None Vascular disorders None View