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 @ 3:18 AM
Ignite Modification Date: 2025-12-26 @ 1:56 AM
NCT ID: NCT00375505
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00375505
Study Brief: The Safety and Efficacy of Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss
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 Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions). None None 3 36 36 36 View
Zometa Zometa None None 6 34 33 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
VERTIGO SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
DENTAL CARIES SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
HAEMATOCHEZIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
PANCREATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DRUG HYPERSENSITIVITY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
FEBRILE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
OSTEONECROSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
BREAST CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
ATAXIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
CEREBRAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
MENORRHAGIA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
ACUTE RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
HYSTERECTOMY SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
GASTROINTESTINAL OEDEMA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
SUBCUTANEOUS ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
OSTEOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
ADENOIDECTOMY SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
VISUAL IMPAIRMENT SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
GASTRITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
IMPAIRED HEALING SYSTEMATIC_ASSESSMENT General disorders MedDRA View
CYSTITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
MASTITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
TOOTH ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
VAGINAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
VULVOVAGINAL CANDIDIASIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
RADIATION SKIN INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
HEPATIC ENZYME INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
BONE PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCULOSKELETAL PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCULOSKELETAL STIFFNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
PAIN IN JAW SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
BASAL CELL CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
MIGRAINE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
MOVEMENT DISORDER SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
PARAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
SLEEP DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
URGE INCONTINENCE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
MENOPAUSAL SYMPTOMS SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
HYPERHIDROSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
HOT FLUSH SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
LYMPHOEDEMA SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
OSTEOARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View