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 @ 4:42 PM
Ignite Modification Date:
2025-12-25 @ 2:30 PM
NCT ID:
NCT01117766
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:
0
Time Frame:
None
Study:
NCT01117766
Study Brief:
Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Pregabalin | During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later. | None | None | 1 | 28 | 20 | 28 | View |
| Placebo | Participants took placebo to match the pregabalin doses BID. | None | None | 1 | 30 | 15 | 30 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Psychomotor hyperactivity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Poor quality sleep | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 12.1 | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.1 | View |
| Diplopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.1 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.1 | View |
| Change of bowel habit | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Tongue coated | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.1 | View |
| Eye infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| Increased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Bradyphrenia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Euphoric mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Withdrawal syndrome | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Hypnagogic hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Initial insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| Erectile dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| Hypoaesthesia facial | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| Phlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |