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 @ 2:51 AM
Ignite Modification Date: 2025-12-26 @ 1:32 AM
NCT ID: NCT00061633
Description: The Safety Population was the "All Treated Population" - all patients who received one treatment. The Primary Analysis was of the Clinically Evaluable (CE) Population. The CE population was composed of the patients who met the inclusion / exclusion criteria or were granted permission to enroll and had a clinical response of "cure" or "failure".
Frequency Threshold: 1
Time Frame: None
Study: NCT00061633
Study Brief: Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Telavancin Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously) None None 3 84 46 84 View
Standard of Care for cSSSI Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin. None None 9 83 50 83 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Necrotizing Fasciitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Subcutaneous Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Inguinal mass SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Vaginal Haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Angioneurotic Oedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Gangrene SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Keratoconjunctivitis Sicca SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphasia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Post-Procedural Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Retching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anasarca SYSTEMATIC_ASSESSMENT General disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Drug Withdrawal Syndrome SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders None View
Feeling jittery SYSTEMATIC_ASSESSMENT General disorders None View
Infusion site pain SYSTEMATIC_ASSESSMENT General disorders None View
Injection Site Extravasation SYSTEMATIC_ASSESSMENT General disorders None View
Injection site phlebitis SYSTEMATIC_ASSESSMENT General disorders None View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain exacerbated SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Wound infection staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blister SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ligament Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Muscle Strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine Aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate Aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood glucose decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood in stool SYSTEMATIC_ASSESSMENT Investigations None View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations None View
Body temperature increased SYSTEMATIC_ASSESSMENT Investigations None View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Hepatic Enzyme increased SYSTEMATIC_ASSESSMENT Investigations None View
HIV Test positive SYSTEMATIC_ASSESSMENT Investigations None View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Inguinal mass SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Uterine Leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Burning sensation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Burning sensation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders None View
Gangrene SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hot Flush SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral Ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Red Man Syndrome SYSTEMATIC_ASSESSMENT General disorders None View
Rigors SYSTEMATIC_ASSESSMENT General disorders None View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacteriuria SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gonorrhea SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Localized Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasal abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Necrotizing Fasciitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Subcutaneous Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Superinfection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tinea Pedis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Catheter related complication SYSTEMATIC_ASSESSMENT General disorders None View
Catheter Site Inflammation SYSTEMATIC_ASSESSMENT General disorders None View
Catheter site rash SYSTEMATIC_ASSESSMENT General disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Confusional State SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Euphoric Mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Albuminuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diabetic neuropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Microalbuminuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Genital Pruritis Female SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal Haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Crackles Lung SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhonchi SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Angioneurotic Oedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Photosensitivity Reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View