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 @ 4:37 PM
Ignite Modification Date:
2025-12-25 @ 2:27 PM
NCT ID:
NCT02230566
Description:
Treatment-emergent adverse events (TEAEs) are presented. Given that the study has only has 12 participants, and a by arm/group analysis would include no more than 3 participants per arm/group, the TEAE summary was planned to present data by treatment only.
Frequency Threshold:
5
Time Frame:
Safety information was collected for all participants who received any study drug from signing the informed consent form through 30 days after last dose of study drug. Mean treatment duration for UX003 was 36.0 weeks, and for placebo was 15.8 weeks.
Study:
NCT02230566
Study Brief:
A Phase 3 Study of UX003 Recombinant Human Betaglucuronidase (rhGUS) Enzyme Replacement Therapy in Patients With Mucopolysaccharidosis Type 7 (MPS 7)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo | Participants received placebo for the first 8 weeks (Group B), 16 weeks (Group C) or 24 weeks (Group D) of the study, based on the blind-start design. | None | None | 0 | 9 | 9 | 9 | View |
| UX003 Active Treatment | Participants received 4 mg/kg UX003 QOW per group assignment (based on the blind-start design) and were dosed through Week 46. All groups received a minimum of 24 weeks of treatment with UX003. | None | None | 2 | 12 | 12 | 12 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.0 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 19.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Infusion site extravasation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Post-traumatic stress disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.0 | View |
| Skin papilloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | View |
| Anaphylactoid reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 19.0 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 19.0 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Catheter site bruise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Infusion site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Infusion site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Infusion site discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Excoriation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Post-traumatic neck syndrome | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Tooth fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Craniocerebral injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Body temperature increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Nasal obstruction | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Clonus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Dysstasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Abnormal faeces | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Cheilosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Rash macular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Rash papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Joint range of motion decreased | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Gastrointestinal viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Rash pustular | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Otitis media acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |