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 @ 2:43 PM
Ignite Modification Date:
2025-12-25 @ 1:13 PM
NCT ID:
NCT03124459
Description:
None
Frequency Threshold:
0
Time Frame:
Part 1 adverse events (AEs) were collected from baseline through Day 141. For Part 2, AEs were collected from on or after the first double-blind study drug administration up to the end of the double-blind period (Day 190). For the open-label period, adverse events are defined as AEs that started or worsened in intensity on or after the first open-label study drug administration up to the end of the study(Day 393/end-of-study).
Study:
NCT03124459
Study Brief:
Study of ACE-083 in Patients With Charcot-Marie-Tooth Disease
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part 1 Cohort 1(150mg) | ACE-083 150 mg IM (tibialis anterior muscle), once every 3 weeks for up to 5 doses. ACE-083: Part 1 - Recombinant fusion protein. | 0 | None | 0 | 6 | 6 | 6 | View |
| Part 2 (Double-blind Placebo Controlled) Placebo Arm | Placebo, once every 3 weeks for up to 9 doses ACE-083: Part 2 - Placebo: buffer solution | 0 | None | 1 | 21 | 19 | 21 | View |
| Part 2 (Double-blind Placebo Controlled) ACE-083 Arm | ACE-083 up to 250 mg IM (tibialis anterior muscle) once every 3 weeks for up to 9 doses ACE-083: Part 2 - Recombinant fusion protein | 0 | None | 0 | 23 | 20 | 23 | View |
| Part 2 (Open Label) | ACE-083 up to 250 mg IM (tibialis anterior muscle), once every 3 weeks for up to 8 doses ACE-083: Part 1 - Recombinant fusion protein. Part 2 - Recombinant fusion protein or buffer solution. | 0 | None | 1 | 40 | 36 | 40 | View |
| Part 1 Cohort 2 (200mg) | ACE-083 200 mg IM, (tibialis anterior muscle), once every 3 weeks for up to 5 doses. ACE-083: Part 1 - Recombinant fusion protein. | 0 | None | 0 | 6 | 6 | 6 | View |
| Part 1 Cohort 3 (250mg) | ACE-083 up to 250 mg IM (tibialis anterior muscle), once every 3 weeks for up to 5 doses. ACE-083: Part 1 - Recombinant fusion protein. | 0 | None | 1 | 6 | 6 | 6 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| muscle spasm | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| joint stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| muscle tightness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| limb discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| muscle twitching | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| musculoskeletal discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| haemarthrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| joint instability | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| systemic lupus erythematosus | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| injection site discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| injection site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| injection site discoloration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| injection site macule | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| injection site warmth | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| vessel puncture site bruise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| injection site dysaethesia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| injection site papule | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| injection site paraesthesia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| local swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| medical device site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| injection site haematoma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| tenderness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| gingivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| onychomycosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| pharyngitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| pneunomia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| sinobronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| fungal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| labyrinthitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| laryngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| lyme disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| skin abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| arthropod sting | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| bone contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| muscle strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| post-traumatic pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| exposure to communicable disease | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| joint dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| restless legs syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| burning sensation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| sensory loss | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| nail discolouration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| skin warm | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| dermatosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| mechanical urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| onychoclasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| pseudofolliculitis barbae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| skin burning sensation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| skin discolouration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| gingival swelling | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| gingival pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| lip swelling | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| gastrointestinal disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| rhinorrheoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| upper respiratory tract congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| paranasal sinus discomfort | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| snoring | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| Behcet's syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| crystal urine present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| myoglobin blood increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| thyroxine free increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| urine analysis abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| bacterial test positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| platelet count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| decreased appetitie | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| iron deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| attention deficit/hyperactivity disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| goitre | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (19.1) | View |
| chromaturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| urine odour abnormal | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| calculus urinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| pelvic pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.1) | View |
| menorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.1) | View |
| tooth extraction | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.1) | View |
| palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| inflammation of lacrimal passage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| vitreous haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| hepatic cyst | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.1) | View |