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 @ 1:20 AM
Ignite Modification Date: 2025-12-25 @ 11:28 PM
NCT ID: NCT00956293
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00956293
Study Brief: Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Goup During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA. None None 11 24 15 24 View
Everolimus Group During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA. None None 28 51 50 51 View
Serious Events(If Any):

Serious 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
PANCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
MITRAL VALVE INCOMPETENCE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
ABDOMINAL MASS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
APHTHOUS STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
CROHN'S DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ENTEROCOLITIS HAEMORRHAGIC SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ILEUS PARALYTIC SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
INGUINAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
GENERAL PHYSICAL HEALTH DETERIORATION SYSTEMATIC_ASSESSMENT General disorders MedDRA View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
TRANSPLANT REJECTION SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
BK VIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
BRONCHOPULMONARY ASPERGILLOSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CYTOMEGALOVIRUS COLITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
FEBRILE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
GASTROENTERITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
GENITAL HERPES SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
HEPATIC CYST INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
HERPES ZOSTER OTICUS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
PYELONEPHRITIS ACUTE SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
UROSEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
GRAFT DYSFUNCTION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
INCISIONAL HERNIA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
POST PROCEDURAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
WOUND DEHISCENCE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
BLOOD CREATININE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
HYPOGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
BASAL CELL CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
FACIAL NERVE DISORDER SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
ACUTE PRERENAL FAILURE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
ANURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
NEPHROSCLEROSIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
RENAL ARTERY STENOSIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
RENAL FAILURE ACUTE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
URETERIC STENOSIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
URINARY TRACT DISORDER SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
DYSPNOEA EXERTIONAL SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PULMONARY ARTERIAL HYPERTENSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
ARTERIOVENOUS FISTULA SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
LYMPHOCELE SYSTEMATIC_ASSESSMENT Vascular disorders 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
APHTHOUS STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
FLATULENCE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
CYTOMEGALOVIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
BLOOD CREATININE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
HYPERLIPIDAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPERURICAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPOCALCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPOMAGNESAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPOPHOSPHATAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
IRON DEFICIENCY SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
VITAMIN D DEFICIENCY SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
PROTEINURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PLEURAL EFFUSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View