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 @ 10:46 PM
Ignite Modification Date: 2025-12-25 @ 8:16 PM
NCT ID: NCT01348269
Description: None
Frequency Threshold: 3
Time Frame: Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
Study: NCT01348269
Study Brief: Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Zoledronic Acid single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v. 0 None 4 34 34 34 View
Placebo placebo with vitamin D 1000 IU/d (NaCl Solution) 0 None 1 14 11 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Post-traumatic neck syndrome SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Generalised tonic-clonic seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Arthropod sting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Blepharospasm SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Renal pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Skin discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Musculoskeletal discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Rheumatic disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Spinal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View