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 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
NCT ID:
NCT00036569
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00036569
Study Brief:
A Phase II Study of Pegylated Interferon Alfa 2b (PEG-Intron(Trademark)) in Children With Diffuse Pontine Gliomas
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Interferon Alfa | 0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria. | None | None | 32 | 32 | 32 | 32 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ALT | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0)/CTC2.0 | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0)/CTC2.0 | View |
| Diplopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0)/CTC2.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0)/CTC2.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0)/CTC2.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0)/CTC2.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0)/CTC2.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0)/CTC2.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0)/CTC2.0 | View |
| Neuropathy-cranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0)/CTC2.0 | View |
| Neuropathy-motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0)/CTC2.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0)/CTC2.0 | View |
| Pyramidal tract dysfunction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0)/CTC2.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0)/CTC2.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0)/CTC2.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0)/CTC2.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0)/CTC2.0 | View |
| Alanine aminotransferase (ALT) | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0)/CTC2.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0)/CTC2.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0)/CTC2.0 | View |
| Aspartate aminotransferase (AST) | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0)/CTC2.0 | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0)/CTC2.0 | View |
| Bilirubin | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0)/CTC2.0 | View |
| Bruising | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0)/CTC2.0 | View |
| Diplopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0)/CTC2.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0)/CTC2.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0)/CTC2.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0)/CTC2.0 | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0)/CTC2.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0)/CTC2.0 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0)/CTC2.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0)/CTC2.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0)/CTC2.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0)/CTC2.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0)/CTC2.0 | View |
| Neuropathy-cranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0)/CTC2.0 | View |
| Neuropathy-motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0)/CTC2.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0)/CTC2.0 | View |
| Personality change | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0)/CTC2.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0)/CTC2.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0)/CTC2.0 | View |
| Pyramidal tract dysfunction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0)/CTC2.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0)/CTC2.0 | View |