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 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
NCT ID:
NCT01370356
Description:
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold:
5
Time Frame:
All AEs (serious and nonserious) were recorded from the date of first dose of study drug (Baseline) up to 30 days after the date of last dose of study drug.
Study:
NCT01370356
Study Brief:
A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Varenicline | Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID. | None | None | 28 | 751 | 467 | 751 | View |
| Placebo | Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed. | None | None | 16 | 742 | 339 | 742 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (v16.1) | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (v16.1) | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (v16.1) | View |
| Supraventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (v16.1) | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (v16.1) | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v16.1) | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v16.1) | View |
| Pancreatic cyst | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v16.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v16.1) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v16.1) | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v16.1) | View |
| Acute tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v16.1) | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v16.1) | View |
| Laryngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v16.1) | View |
| Lobar pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v16.1) | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v16.1) | View |
| Peritonitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v16.1) | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v16.1) | View |
| Foot fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v16.1) | View |
| Rib fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v16.1) | View |
| Road traffic accident | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v16.1) | View |
| Thermal burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v16.1) | View |
| Diabetes mellitus inadequate control | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v16.1) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v16.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v16.1) | View |
| Costochondritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v16.1) | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v16.1) | View |
| Musculoskeletal chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v16.1) | View |
| Bladder transitional cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (v16.1) | View |
| Breast cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (v16.1) | View |
| Prostate cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (v16.1) | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v16.1) | View |
| Intercostal neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v16.1) | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v16.1) | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v16.1) | View |
| Ruptured cerebral aneurysm | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v16.1) | View |
| Alcohol abuse | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v16.1) | View |
| Alcoholism | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v16.1) | View |
| Delirium tremens | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v16.1) | View |
| Depression suicidal | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v16.1) | View |
| Intentional self-injury | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v16.1) | View |
| Suicidal ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v16.1) | View |
| Calculus ureteric | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (v16.1) | View |
| Ovarian cyst | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (v16.1) | View |
| Ovarian haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (v16.1) | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v16.1) | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v16.1) | View |
| Diabetic foot | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v16.1) | View |
| Hospitalisation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (v16.1) | View |
| Aortic aneurysm rupture | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (v16.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (v16.1) | View |
| Hypertensive crisis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (v16.1) | View |
| Peripheral arterial occlusive disease | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (v16.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v16.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v16.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v16.1) | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v16.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v16.1) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v16.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v16.1) | View |
| Abnormal dreams | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v16.1) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v16.1) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v16.1) | View |