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 @ 2:55 PM
Ignite Modification Date: 2025-12-25 @ 1:20 PM
NCT ID: NCT01981759
Description: Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
Frequency Threshold: 0
Time Frame: Entire study duration, from Randomization through the final follow-up at Week 36.
Study: NCT01981759
Study Brief: D-Cycloserine Augmentation of Cognitive Behavioral Therapy for Delusions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits). Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12. 24 None 0 28 24 28 View
D-Cycloserine Participants will receive a weekly dose of 50 mg placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits). Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12. 24 None 3 30 24 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Psychiatric Hospitalization SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Medical Hospitalization SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Auditory Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Back Ache SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blisters SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Blood Sugar Increased SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Blurred Vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bruise SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Burning Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Vascular disorders None View
Common Cold SYSTEMATIC_ASSESSMENT Infections and infestations None View
Concentration Impaired SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nasal Congestion SYSTEMATIC_ASSESSMENT Infections and infestations None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Impaired Coordination SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Coughing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Muscle Cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cyst SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Decreased Sleep SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Difficulty Thinking SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness Upon Standing SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Drooling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Drowsiness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Drowsy on Awakening SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT General disorders None View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ear Feels Clogged SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Eye Hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Facial Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Faintness SYSTEMATIC_ASSESSMENT Vascular disorders None View
Falling Down SYSTEMATIC_ASSESSMENT Nervous system disorders None View
False Sensation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Feeling Strange SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Flu-like Symptoms SYSTEMATIC_ASSESSMENT Infections and infestations None View
Frequency of Urination SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Gingival Bleeding SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hair Loss SYSTEMATIC_ASSESSMENT General disorders None View
Hair Thinning SYSTEMATIC_ASSESSMENT General disorders None View
Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hot Flashes SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hyperventilation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Incarceration SYSTEMATIC_ASSESSMENT Social circumstances None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Skin Irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Jaw Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Knee Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Libido Decreased SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Loss of Consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lung Disease Obstruvtive SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Memory Impaired SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mental Concentration Difficulty SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mental Dullness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Muscle Cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle Spasm/Twitch SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle Weakness/Fatigue SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea and Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nervousness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nightmares SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Numbness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Foot Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Stomach Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Panic Attack SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Paranoia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pneumonia and Dehydration SYSTEMATIC_ASSESSMENT Infections and infestations None View
Appetite Decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Appetite Increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Abdominal Discomfort SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anorgasmia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Apathy SYSTEMATIC_ASSESSMENT Psychiatric disorders None View