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 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
NCT ID:
NCT01376804
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01376804
Study Brief:
A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Valganciclovir | Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm \[7 \* Body Surface Area \* Creatinine Clearance\]. | None | None | 41 | 56 | 56 | 56 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Escherichia Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Viral Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Bacterial Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Viral Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Chronic Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Diarrhoea Infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Gastroenteritis Norovirus | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Gastrointestinal Protozoal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Gastrointestinal Viral Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Pneumonia Mycoplasmal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Pneumonia Respiratory Syncytial Viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Pyelonephritis Acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Rotavirus Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Septic Shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Urinary Tract Infection Bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Varicella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Bicytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Bladder Dysfunction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Neurogenic Bladder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Ureteric Obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Urethral Obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Urinary Tract Obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Vesicoureteric Reflux | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Blood Creatinine Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| HLA Marker Study Positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Transplant Rejection | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 16.0 | View |
| Kidney Transplant Rejection | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 16.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Type 1 Diabetes Mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Aphthous Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Complications Of Transplant Surgery | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Complications Of Transplanted Kidney | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Benign Intracranial Hypertension | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Papilloedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| Device Leakage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Tonsillar Hypertrophy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Vesicoureteral Reflux Surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Escherichia urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Renal tubular acidosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Metabolic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| BK virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |