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 @ 3:25 PM
Ignite Modification Date:
2025-12-25 @ 1:42 PM
NCT ID:
NCT00649792
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00649792
Study Brief:
Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Fampridine-SR | Tablets, 10 mg, BID | None | None | 39 | 214 | 205 | 214 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Accidental Overdose | None | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Arthritis Infective | None | Infections and infestations | MedDRA (8.1) | View |
| Back Pain | None | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | View |
| Bile Duct Stone | None | Hepatobiliary disorders | MedDRA (8.1) | View |
| Bronchitis | None | Infections and infestations | MedDRA (8.1) | View |
| Carotid Artery Stenosis | None | Nervous system disorders | MedDRA (8.1) | View |
| Cellulitis | None | Infections and infestations | MedDRA (8.1) | View |
| Cholecystitis | None | Hepatobiliary disorders | MedDRA (8.1) | View |
| Clostridium Colitis | None | Infections and infestations | MedDRA (8.1) | View |
| Colitis | None | Gastrointestinal disorders | MedDRA (8.1) | View |
| Completed Suicide | None | Psychiatric disorders | MedDRA (8.1) | View |
| Coronary Artery Disease | None | Cardiac disorders | MedDRA (8.1) | View |
| Dehydration | None | Metabolism and nutrition disorders | MedDRA (8.1) | View |
| Device Related Infection | None | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Dizziness | None | Nervous system disorders | MedDRA (8.1) | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Fall | None | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Gastritis | None | Gastrointestinal disorders | MedDRA (8.1) | View |
| Headache | None | Nervous system disorders | MedDRA (8.1) | View |
| Intestinal Perforation | None | Gastrointestinal disorders | MedDRA (8.1) | View |
| Lower Limb Fracture | None | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Lumbar Puncture Headache | None | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Multiple Sclerosis Relapse | None | Nervous system disorders | MedDRA (8.1) | View |
| Muscle Spasticity | None | Nervous system disorders | MedDRA (8.1) | View |
| Nausea | None | Gastrointestinal disorders | MedDRA (8.1) | View |
| Oesophagitis | None | Gastrointestinal disorders | MedDRA (8.1) | View |
| Orbital Infection | None | Infections and infestations | MedDRA (8.1) | View |
| Otitis Externa | None | Infections and infestations | MedDRA (8.1) | View |
| Ovarian Neoplasm | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | View |
| Overdose | None | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Pneumonia | None | Infections and infestations | MedDRA (8.1) | View |
| Prostate Cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | View |
| Pulmonary Embolism | None | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Sepsis | None | Infections and infestations | MedDRA (8.1) | View |
| Spinal Fracture | None | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Suicide Attempt | None | Psychiatric disorders | MedDRA (8.1) | View |
| Syncope | None | Nervous system disorders | MedDRA (8.1) | View |
| Tibia Fracture | None | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Tuberculosis | None | Infections and infestations | MedDRA (8.1) | View |
| Urinary Tract Infection | None | Infections and infestations | MedDRA (8.1) | View |
| Urosepsis | None | Infections and infestations | MedDRA (8.1) | View |
| Uterine Leiomyoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | View |
| Vertigo | None | Ear and labyrinth disorders | MedDRA (8.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Adverse Drug Reaction | None | General disorders | MedDRA (8.1) | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | View |
| Asthenia | None | General disorders | MedDRA (8.1) | View |
| Back Pain | None | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | View |
| Balance Disorder | None | Nervous system disorders | MedDRA (8.1) | View |
| Blood Creatine Phosphokinase Increased | None | Investigations | MedDRA (8.1) | View |
| Contusion | None | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Fall | None | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Headache | None | Nervous system disorders | MedDRA (8.1) | View |
| Hypoaesthesia | None | Nervous system disorders | MedDRA (8.1) | View |
| Influenza | None | Infections and infestations | MedDRA (8.1) | View |
| Insomnia | None | Psychiatric disorders | MedDRA (8.1) | View |
| Multiple Sclerosis Relapse | None | Nervous system disorders | MedDRA (8.1) | View |
| Muscle Spasms | None | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | View |
| Muscle Spasticity | None | Nervous system disorders | MedDRA (8.1) | View |
| Muscular Weakness | None | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA (8.1) | View |
| Nausea | None | Gastrointestinal disorders | MedDRA (8.1) | View |
| Pain In Extremity | None | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | View |
| Pyrexia | None | General disorders | MedDRA (8.1) | View |
| Shoulder Pain | None | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | View |
| Sinusitis | None | Infections and infestations | MedDRA (8.1) | View |
| Skin Laceration | None | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Upper Respiratory Tract Infection | None | Infections and infestations | MedDRA (8.1) | View |
| Urinary Tract Infection | None | Infections and infestations | MedDRA (8.1) | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Depression | None | Psychiatric disorders | MedDRA (8.1) | View |
| Dizziness | None | Nervous system disorders | MedDRA (8.1) | View |
| Fatique | None | General disorders | MedDRA (8.1) | View |
| Oedema Peripheral | None | General disorders | MedDRA (8.1) | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA (8.1) | View |