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 @ 12:10 PM
Ignite Modification Date:
2025-12-25 @ 11:59 AM
NCT ID:
NCT00418561
Description:
From study drug administration up to Week 28 until evaluation (when last cohort had 26-week evaluation and data management performed within 4 weeks)
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00418561
Study Brief:
Metazym for the Treatment of Patients With Late Infantile Metachromatic Leukodystrophy (MLD)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort 1 | Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight. | None | None | 1 | 4 | 4 | 4 | View |
| Cohort 2 | Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight. | None | None | 2 | 5 | 5 | 5 | View |
| Cohort 3 | Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight. | None | None | 2 | 4 | 4 | 4 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Malnutrition | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.2) | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.2) | View |
| Bronchitis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.2) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.2) | View |
| Herpangina | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.2) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.2) | View |
| Acute tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.2) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.2) | View |
| Varicella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.2) | View |
| Postoperative infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.2) | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.2) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.2) | View |
| Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.2) | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.2) | View |
| Type III immune complex mediated reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (8.2) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.2) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.2) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.2) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.2) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.2) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.2) | View |
| Pharyngolaryngeal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.2) | View |
| Pharyngeal oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.2) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.2) | View |
| Drug specific antibody present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.2) | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.2) | View |
| Blood iron decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.2) | View |
| Muscle spasticity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.2) | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.2) | View |
| Speech disorder developmental | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.2) | View |
| Mutism | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.2) | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.2) | View |
| Feeding tube complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.2) | View |
| Device occlusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.2) | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.2) | View |
| Pallor | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.2) | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.2) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.2) | View |
| Blindness | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (8.2) | View |
| Bronchitis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.2) | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.2) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.2) | View |