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 @ 4:33 PM
Ignite Modification Date:
2025-12-25 @ 2:24 PM
NCT ID:
NCT01182766
Description:
Adverse events reporting followed the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 (US Department of Health and Human Services, 2017).
Frequency Threshold:
0
Time Frame:
Adverse Events data were collected at all study visits (18 weeks), plus 30-day follow-up.
Study:
NCT01182766
Study Brief:
New Treatment for Alcohol and Nicotine Dependence
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 | Placebo with brief behavioral enhancement therapy | 0 | None | 8 | 84 | 63 | 84 | View |
| Low-Dose Topiramate | Low-dose Topiramate (up to 125 mg/day) with brief behavioral enhancement therapy | 0 | None | 7 | 75 | 59 | 75 | View |
| High-Dose Topiramate | High-dose Topiramate (up to 250 mg/day) with brief behavioral enhancement therapy | 0 | None | 7 | 77 | 63 | 77 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Allergic Reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (Unspecified) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Concentration Impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Drug Withdrawal | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Intracranial Hemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Neoplasms Benign, Malignant And Unspecified Incl Cysts And Polyps - Other | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Surgical And Medical Procedures - Other | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (Unspecified) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Amnesia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Platelet Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Pregnancy, Puerperium And Perinatal Conditions - Other | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | CTCAE (Unspecified) | View |
| Productive Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Alcohol Intolerance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Allergic Rhinitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Anal Hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (Unspecified) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Bladder Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Blurred Vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (Unspecified) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| Chest Pain - Cardiac | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (Unspecified) | View |
| Concentration Impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Creatinine Increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Dental Caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Drug Withdrawal | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Dry Skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Dysphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Ear Pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (Unspecified) | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Edema - Face | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Edema - Limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Edema - Trunk | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Ejaculation Disorder | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (Unspecified) | View |
| Erectile Dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (Unspecified) | View |
| Eye Disorders - Other | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| Eye Pain | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Flashing Lights | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Floaters | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| Flu Like Symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Gait Disturbance | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Gastroesophageal Reflux Disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Ggt Increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Gingival Pain | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| Gum Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Hallucinations | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Hearing Impaired | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (Unspecified) | View |
| Hemoglobin Increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Hyperacusis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Hypercholesterolemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Hyperosmia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (Unspecified) | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (Unspecified) | View |
| Hypothermia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Increased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Injury, Poisoning And Procedural Complications - Other | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (Unspecified) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Investigations - Other | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Irregular Menstruation | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (Unspecified) | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Libido Decreased | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Libido Increased | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Lung Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Lymph Node Pain | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (Unspecified) | View |
| Mania | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Memory Impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Middle Ear Inflammation | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (Unspecified) | View |
| Mood Alteration | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Muscle Weakness - Lower Limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Neck Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Neoplasms Benign, Malignant And Unspecified Incl Cysts And Polyps - Other | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | View |
| Neutrophil Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Otitis Externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Pain in Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Paresthesias | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Periorbital Edema | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Psychiatric Disorders - Other | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Psychosis | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Radiculopathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Rash - Pustular | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Scleral Disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Skin Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Sore Throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Speech Disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Suicidal Ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Surgical And Medical Procedures - Other | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (Unspecified) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (Unspecified) | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (Unspecified) | View |
| Tooth Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Upper Respiratory Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Urinary Frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (Unspecified) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Urine Discoloration | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (Unspecified) | View |
| Urine Output Decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Vaginal Discharge | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (Unspecified) | View |
| Vaginal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Vaginal Pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (Unspecified) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Watering Eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| Weight Gain | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Weight Loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| White Blood Cell Decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |