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 @ 3:38 AM
Ignite Modification Date: 2025-12-26 @ 2:22 AM
NCT ID: NCT00299702
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Study: NCT00299702
Study Brief: Evaluation of Effectiveness of Risperdal® Consta® Compared to Abilify® Over a Two-year Period in Patients With Schizophrenia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RISPERDAL CONSTA 25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks None None 31 179 151 179 View
Abilify 10-30 mg once daily oral for 104 weeks None None 35 176 141 176 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ANAL FISSURE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
DEATH NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
ANAEMIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10 View
PANCYTOPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10 View
CARDIO-RESPIRATORY ARREST NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
GOITRE NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10 View
DIARRHOEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
IRRITABLE BOWEL SYNDROME NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
MELAENA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
PYREXIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
CELLULITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
PNEUMONIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
ANKLE FRACTURE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10 View
JOINT DISLOCATION NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10 View
MULTIPLE DRUG OVERDOSE ACCIDENTAL NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10 View
ROAD TRAFFIC ACCIDENT NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10 View
DEHYDRATION NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
DIABETIC KETOACIDOSIS NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
ARTHRITIS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
LEIOMYOMA NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10 View
AKATHISIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
CONVULSION NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
SYNCOPE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
PSYCHOTIC DISORDER NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
SCHIZOPHRENIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
SUICIDAL IDEATION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
AGGRESSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
DEPRESSION SUICIDAL NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
AFFECT LABILITY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
ALCOHOLISM NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
COMPLETED SUICIDE NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
DRUG DEPENDENCE NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
HOMICIDAL IDEATION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
MANIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
MENTAL STATUS CHANGES NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
SUICIDE ATTEMPT NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
EPISTAXIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
HYPERPROLACTINAEMIA NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10 View
DIARRHOEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
ABDOMINAL PAIN UPPER NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
SALIVARY HYPERSECRETION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
PYREXIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
ASTHENIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
INJECTION SITE PAIN NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
NASOPHARYNGITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
UPPER RESPIRATORY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
INFLUENZA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
WEIGHT INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
DECREASED APPETITE NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
PAIN IN EXTREMITY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
ARTHRALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
TREMOR NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
AKATHISIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
DIZZINESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
HYPERSOMNIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
SOMNOLENCE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
SEDATION NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
PSYCHOTIC DISORDER NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
SCHIZOPHRENIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
DEPRESSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
RESTLESSNESS NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
SLEEP DISORDER NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View