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 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
NCT ID:
NCT00206102
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00206102
Study Brief:
A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizophrenia or Schizoaffective Disorder
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Quetiapine Fumarate | Quetiapine fumarate - flexibly dosed (200 - 800 mg/day) | None | None | 151 | 596 | 476 | 596 | View |
| Risperidone | Risperidone - flexibly dosed (2 - 8 mg/day) | None | None | 114 | 502 | 368 | 502 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 11.1 | View |
| Angina Pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.1 | View |
| Cardiac Failure Congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.1 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.1 | View |
| Coronary Artery Disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.1 | View |
| Diastolic Dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.1 | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.1 | View |
| Hyperparathyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 11.1 | View |
| Hypoparathyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 11.1 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 11.1 | View |
| Intestinal Ischaemia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Pancreatic Insufficiency | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Abdominal Discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Anal Fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Intestinal Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Pancreatitis Acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| Non-Cardiac Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 11.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 11.1 | View |
| Cholecystitis Acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 11.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Conjunctivitis Bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Diarrhoea Infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Gastroenteritis Viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Skin Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Localised Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Pilonidal Cyst | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Postoperative Wound Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Alcohol Poisoning | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Accidental Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Drug Toxicity | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Incisional Hernia | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Intentional Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Joint Dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Multiple Drug Overdose Accidental | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Procedural Pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Therapeutic Agent Toxicity | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Thermal Burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Ankle Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Respiratory Fume Inhalation Disorder | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Electrocardiogram Qt Prolonged | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Neutrophil Count Decreased | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Diabetes Mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 11.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 11.1 | View |
| Diabetic Ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 11.1 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 11.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 11.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 11.1 | View |
| Inguinal Mass | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | View |
| Muscular Weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | View |
| Rhabdomyolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | View |
| Flank Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | View |
| Intervertebral Disc Disorder | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | View |
| Intervertebral Disc Protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | View |
| Lumbar Spinal Stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | View |
| Cervix Carcinoma Stage 0 | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | View |
| Metastases To Liver | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | View |
| Oesophageal Adenocarcinoma Metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | View |
| Uterine Leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Hemiparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Transient Ischaemic Attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Multiple Sclerosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Subarachnoid Haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Psychotic Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Schizophrenia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Schizoaffective Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Suicidal Ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Suicide Attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Schizophrenia, Paranoid Type | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Aggression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Alcohol Abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Completed Suicide | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Drug Abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Paranoia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Affective Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Delusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Homicidal Ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Major Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Acute Psychosis | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Alcoholism | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Catatonia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Drug Dependence | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Flashback | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Self Injurious Behaviour | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Somatic Delusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Substance Abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Suicidal Behaviour | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Bladder Disorder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 11.1 | View |
| Renal Failure Acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 11.1 | View |
| Breast Mass | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 11.1 | View |
| Chronic Obstructive Pulmonary Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Bronchitis Chronic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Angioedema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.1 | View |
| Substance Abuser | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.1 | View |
| Malignant Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.1 | View |
| Arteriosclerosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Weight Increased | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Sedation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Akathisia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Extrapyramidal Disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |