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:
2025-12-25 @ 12:30 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
NCT ID:
NCT01251367
Description:
AE data is reported as TEAEs. An AE was reported as a TEAE if it arose or the intensity increased during the treatment phase of this study.
Frequency Threshold:
5
Time Frame:
From baseline to EOS (maximum duration of 52 weeks).
Study:
NCT01251367
Study Brief:
Dysport® Adult Lower Limb Spasticity Follow-on Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Total Dysport® | Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA). | None | None | 43 | 345 | 69 | 345 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Venous thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
| Subdural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Wrist fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Fibula fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.0) | View |
| Coronary artery dissection | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.0) | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.0) | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.0) | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.0) | View |
| Haemothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Completed suicide | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.0) | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.0) | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.0) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Intestinal polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (18.0) | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (18.0) | View |
| Intervertebral disc degeneration | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Anal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |