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 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
NCT ID:
NCT00389818
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00389818
Study Brief:
Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| DR-COP | Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen. | None | None | 26 | 40 | 38 | 40 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | None | Blood and lymphatic system disorders | MedDRA (12.0) | View |
| Febrile Neutropenia | None | Blood and lymphatic system disorders | MedDRA (12.0) | View |
| Optic nerve disorder | None | Eye disorders | MedDRA (12.0) | View |
| Abdominal pain | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Constipation | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Dysphagia | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Gastric hemorrhage | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Ileal obstruction | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Ileal perforation | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Ileus | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Nausea | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Small intestinal obstruction | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Death | None | General disorders | MedDRA (12.0) | View |
| Fever | None | General disorders | MedDRA (12.0) | View |
| Non-cardiac chest pain | None | General disorders | MedDRA (12.0) | View |
| Pain | None | General disorders | MedDRA (12.0) | View |
| Abdominal infection | None | Infections and infestations | MedDRA (12.0) | View |
| Cather related infection | None | Infections and infestations | MedDRA (12.0) | View |
| Lung infection | None | Infections and infestations | MedDRA (12.0) | View |
| Skin infection | None | Infections and infestations | MedDRA (12.0) | View |
| Neutrophil count decreased | None | Investigations | MedDRA (12.0) | View |
| Platelet count decreased | None | Investigations | MedDRA (12.0) | View |
| Weight loss | None | Investigations | MedDRA (12.0) | View |
| White blood cell decreased | None | Investigations | MedDRA (12.0) | View |
| Dehydration | None | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hyperuricemia | None | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hypocalcemia | None | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hypokalemia | None | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Bone pain | None | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Headache | None | Nervous system disorders | MedDRA (12.0) | View |
| Intracranial hemorrhage | None | Nervous system disorders | MedDRA (12.0) | View |
| Leukoencephalopathy | None | Nervous system disorders | MedDRA (12.0) | View |
| Peripheral motor neuropathy | None | Nervous system disorders | MedDRA (12.0) | View |
| Peripheral sensory neuropathy | None | Nervous system disorders | MedDRA (12.0) | View |
| Seizure | None | Nervous system disorders | MedDRA (12.0) | View |
| Confusion | None | Psychiatric disorders | MedDRA (12.0) | View |
| Delirium | None | Nervous system disorders | MedDRA (12.0) | View |
| Cystitis noninfective | None | Renal and urinary disorders | MedDRA (12.0) | View |
| Renal and urinary disorders, other | None | Renal and urinary disorders | MedDRA (12.0) | View |
| Bronchospasm | None | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Pleural effusion | None | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Hypotension | None | Vascular disorders | MedDRA (12.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Diarrhea | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Dysphagia | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Gastric ulcer | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Mucositis, oral | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Chills | None | General disorders | MedDRA (12.0) | View |
| Edema, limbs | None | General disorders | MedDRA (12.0) | View |
| Fatigue | None | General disorders | MedDRA (12.0) | View |
| Fever | None | General disorders | MedDRA (12.0) | View |
| Non-cardiac chest pain | None | General disorders | MedDRA (12.0) | View |
| Pain | None | General disorders | MedDRA (12.0) | View |
| Infections and investigations, other | None | Infections and infestations | MedDRA (12.0) | View |
| Mucosal infections | None | Infections and infestations | MedDRA (12.0) | View |
| Upper respiratory infection | None | Infections and infestations | MedDRA (12.0) | View |
| Urinary tract infection | None | Infections and infestations | MedDRA (12.0) | View |
| Alanine aminotransferase increased | None | Investigations | MedDRA (12.0) | View |
| Alkaline phosphatase increased | None | Investigations | MedDRA (12.0) | View |
| Aspartate aminotransferase increased | None | Investigations | MedDRA (12.0) | View |
| Lymphocyte count decreased | None | Investigations | MedDRA (12.0) | View |
| Neutrophil count decreased | None | Investigations | MedDRA (12.0) | View |
| Platelet count decreased | None | Investigations | MedDRA (12.0) | View |
| Weight gain | None | Investigations | MedDRA (12.0) | View |
| Weight loss | None | Investigations | MedDRA (12.0) | View |
| White blood cell decreased | None | Investigations | MedDRA (12.0) | View |
| Anorexia | None | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Dehydration | None | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hyperglycemia | None | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Bone pain | None | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Headache | None | Nervous system disorders | MedDRA (12.0) | View |
| Leukoencephalopathy | None | Nervous system disorders | MedDRA (12.0) | View |
| Memory impairment | None | Nervous system disorders | MedDRA (12.0) | View |
| Peripheral motor neuropathy | None | Nervous system disorders | MedDRA (12.0) | View |
| Peripheral sensory neuropathy | None | Nervous system disorders | MedDRA (12.0) | View |
| Anxiety | None | Psychiatric disorders | MedDRA (12.0) | View |
| Depression | None | Psychiatric disorders | MedDRA (12.0) | View |
| Insomnia | None | Psychiatric disorders | MedDRA (12.0) | View |
| Urinary frequency | None | Renal and urinary disorders | MedDRA (12.0) | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Pharyngolaryngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Alopecia | None | Skin and subcutaneous tissue disorders | MedDRA (12.0) | View |
| Dry skin | None | Skin and subcutaneous tissue disorders | MedDRA (12.0) | View |
| Hyperhidrosis | None | Skin and subcutaneous tissue disorders | MedDRA (12.0) | View |
| Nail loss | None | Skin and subcutaneous tissue disorders | MedDRA (12.0) | View |
| Palmar-plantar erythrodysesthesia syndrome | None | Skin and subcutaneous tissue disorders | MedDRA (12.0) | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | MedDRA (12.0) | View |
| Skin and subcutaneous tissue disorders, other | None | Skin and subcutaneous tissue disorders | MedDRA (12.0) | View |
| Anemia | None | Blood and lymphatic system disorders | MedDRA (12.0) | View |
| Abdominal pain | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Nausea | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Blood and lymphatic system disorders, other | None | Blood and lymphatic system disorders | MedDRA (12.0) | View |
| Sinus tachycardia | None | Cardiac disorders | MedDRA (12.0) | View |
| Ear and labyrinth disorders, other | None | Ear and labyrinth disorders | MedDRA (12.0) | View |
| Skin hyperpigmentation | None | Skin and subcutaneous tissue disorders | MedDRA (12.0) | View |