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 @ 9:18 PM
Ignite Modification Date: 2025-12-25 @ 7:06 PM
NCT ID: NCT01422304
Description: Adverse event tables include participants in APaT population
Frequency Threshold: 5
Time Frame: Up to 14 days post study drug administration
Study: NCT01422304
Study Brief: Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sugammadex For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline \[NaCl 0.9%\] to match volume of neostigmine/glycopyrrolate \[or neostigmine/atropine\] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg. None None 39 596 491 596 View
Usual Care For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline \[NaCl 0.9%\] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline \[NaCl 0.9%\] to match volume of sugammadex that would have been administered). None None 40 588 499 588 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Mitral valve stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Vitreous detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Colitis ischaemic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Tooth loss SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Device breakage SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Device dislocation SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Drug withdrawal syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Impaired healing SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Clostridial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Post procedural infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Rotavirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Wound infection staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Anaemia postoperative SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Femoral nerve injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Incision site haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Periprosthetic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Postoperative wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Subcutaneous haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Wound haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Wound secretion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Joint range of motion decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Muscle haemorrhage SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Chronic lymphocytic leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Nerve compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Peripheral nerve lesion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Reversible ischaemic neurological deficit SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Oliguria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Apnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Supportive care SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 15.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Anaemia postoperative SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View