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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 11:36 PM
NCT ID:
NCT05176093
Description:
All study-related Adverse Events will be collected starting after completion of the Informed Consent process at Screening to Day 0/randomization of the VMALS-002-2 study. Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events will be collected after first injections of VMALS-002-2 study until the time that the Participant withdraws their informed consent for this extension study.
Frequency Threshold:
0
Time Frame:
Day 0 to Day 365, or until participant withdraws informed consent for this extension study, which can be anytime between Day 180 and Day 365.
Study:
NCT05176093
Study Brief:
A 6-Month Extension Study to Assess the Long-Term Safety of Engensis in Amyotrophic Lateral Sclerosis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Engensis | Active Comparator: Engensis 64 mg Engensis per Treatment Cycle, with each of 3 cycles composed of 2 days of 128 injections each to the right and left target muscles, spaced 2 weeks apart Engensis: Lyophilized biologic to be reconstituted containing Engensis | 0 | None | 1 | 4 | 4 | 4 | View |
| Placebo | Placebo Comparator: Placebo 32 mL of Placebo per Treatment Cycle, with each of 3 cycles composed of 2 days of 128 injections each to the right and left target muscles, spaced 2 weeks apart Placebo: Injectable Liquid | 0 | None | 1 | 4 | 4 | 4 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA 23.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA 23.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA 23.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA 23.0 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA 23.0 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA 23.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA 23.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA 23.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA 23.0 | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA 23.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA 23.0 | View |
| Oropharyneal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA 23.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA 23.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA 23.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA 23.0 | View |
| Haemorrhoids thrombosed | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA 23.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA 23.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA 23.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA 23.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA 23.0 | View |
| Muscle twitching | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA 23.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA 23.0 | View |
| Kidney infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA 23.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA 23.0 | View |
| Dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA 23.0 | View |
| Muscle contractions involuntary | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA 23.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA 23.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA 23.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA 23.0 | View |
| Multiple injuries | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA 23.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA 23.0 | View |
| Skin irritation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA 23.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA 23.0 | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA 23.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA 23.0 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MeDRA 23.0 | View |
| Bone density descreased | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA 23.0 | View |
| Hypophagia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA 23.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MeDRA 23.0 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MeDRA 23.0 | View |