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:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT00331006
Description:
Restricted to the 16 subjects who received at least one dose of rituximab.
Frequency Threshold:
0
Time Frame:
Through week 100
Study:
NCT00331006
Study Brief:
Rituximab to Treat Severe Hemophilia A
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Rituximab | Rituximab administered at a dose of 375 mg/m\^2 by slow intravenous infusion once per week for 4 weeks | None | None | 11 | 16 | 15 | 16 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Allergic reaction/hypersensitivity | SYSTEMATIC_ASSESSMENT | General disorders | Modified CTCAE 3.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | Modified CTCAE 3.0 | View |
| Central line infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | Modified CTCAE 3.0 | View |
| Pulmonary/upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | Modified CTCAE 3.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | Modified CTCAE 3.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Modified CTCAE 3.0 | View |
| Mallory-Weiss tear | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Modified CTCAE 3.0 | View |
| Viral meningitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | Modified CTCAE 3.0 | View |
| Zoster infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | Modified CTCAE 3.0 | View |
| Bleeding and/or hematoma due to injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Modified CTCAE 3.0 | View |
| Bleeding and/or hematoma due to procedure complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Modified CTCAE 3.0 | View |
| Hematoma due to injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Modified CTCAE 3.0 | View |
| Hematoma due to procedure complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Modified CTCAE 3.0 | View |
| Joint and other bleeding due to injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Modified CTCAE 3.0 | View |
| Joint bleeding due to injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Modified CTCAE 3.0 | View |
| Bleeding and/or hematoma - spontaneous | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Modified CTCAE 3.0 | View |
| Bone fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Modified CTCAE 3.0 | View |
| Joint and other bleeding - spontaneous | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Modified CTCAE 3.0 | View |
| Joint bleeding - spontaneous | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Modified CTCAE 3.0 | View |
| Joint bleeding due to procedure complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Modified CTCAE 3.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Modified CTCAE 3.0 | View |
| Subdural hemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Modified CTCAE 3.0 | View |
| Shortness of breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Modified CTCAE 3.0 | View |
| Port placement | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | Modified CTCAE 3.0 | View |
| Port removal and replacement | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | Modified CTCAE 3.0 | View |
| Synovectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | Modified CTCAE 3.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | Modified CTCAE 3.0 | View |
| Splenic hematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | Modified CTCAE 3.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | Modified CTCAE 3.0 | View |
| Enlarged lymph nodes | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | Modified CTCAE 3.0 | View |
| Increased blood lymphocytes | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | Modified CTCAE 3.0 | View |
| Increased blood monocytes | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | Modified CTCAE 3.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | Modified CTCAE 3.0 | View |
| White blood cell decrease | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | Modified CTCAE 3.0 | View |
| Sweating | SYSTEMATIC_ASSESSMENT | Endocrine disorders | Modified CTCAE 3.0 | View |
| Pink eye | SYSTEMATIC_ASSESSMENT | Eye disorders | Modified CTCAE 3.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Modified CTCAE 3.0 | View |
| Bleeding - spontaneous | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Modified CTCAE 3.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Modified CTCAE 3.0 | View |
| Heartburn | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Modified CTCAE 3.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Modified CTCAE 3.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Modified CTCAE 3.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Modified CTCAE 3.0 | View |
| Bleed and/or hematoma | SYSTEMATIC_ASSESSMENT | General disorders | Modified CTCAE 3.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | Modified CTCAE 3.0 | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | Modified CTCAE 3.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | Modified CTCAE 3.0 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | General disorders | Modified CTCAE 3.0 | View |
| Decreased ALT | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | Modified CTCAE 3.0 | View |
| Elevated ALT | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | Modified CTCAE 3.0 | View |
| Allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | Modified CTCAE 3.0 | View |
| Cold sore | SYSTEMATIC_ASSESSMENT | Infections and infestations | Modified CTCAE 3.0 | View |
| Group A strep | SYSTEMATIC_ASSESSMENT | Infections and infestations | Modified CTCAE 3.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | Modified CTCAE 3.0 | View |
| Septic polyarthritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | Modified CTCAE 3.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | Modified CTCAE 3.0 | View |
| Bleed and/or hematoma due to injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Modified CTCAE 3.0 | View |
| Bleeding due to injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Modified CTCAE 3.0 | View |
| Bleeding due to procedure complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Modified CTCAE 3.0 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Modified CTCAE 3.0 | View |
| Joint bleeding due to injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Modified CTCAE 3.0 | View |
| Joint pain due to injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Modified CTCAE 3.0 | View |
| vaccination site reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Modified CTCAE 3.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Modified CTCAE 3.0 | View |
| Joint bleeding, spontaneous | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Modified CTCAE 3.0 | View |
| Joint pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Modified CTCAE 3.0 | View |
| Joint pain, spontaneous | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Modified CTCAE 3.0 | View |
| Joint range of motion decreased | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Modified CTCAE 3.0 | View |
| Muscle pain, spontaneous | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Modified CTCAE 3.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Modified CTCAE 3.0 | View |
| Bleed and/or hematoma - spontaneous | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Modified CTCAE 3.0 | View |
| Bells palsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Modified CTCAE 3.0 | View |
| Bleeding - spontaneous | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Modified CTCAE 3.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Modified CTCAE 3.0 | View |
| Intolerance to light | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Modified CTCAE 3.0 | View |
| Bleeding - spontaneous | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | Modified CTCAE 3.0 | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | Modified CTCAE 3.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Modified CTCAE 3.0 | View |
| Bleeding - spontaneous | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Modified CTCAE 3.0 | View |
| Cold | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | Modified CTCAE 3.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Modified CTCAE 3.0 | View |
| Elevated carbon dioxide in the blood | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Modified CTCAE 3.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Modified CTCAE 3.0 | View |
| Runny nose | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Modified CTCAE 3.0 | View |
| Sore throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Modified CTCAE 3.0 | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Modified CTCAE 3.0 | View |
| Bleed and/or hematoma - spontaneous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Modified CTCAE 3.0 | View |
| Hematoma - spontaneous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Modified CTCAE 3.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Modified CTCAE 3.0 | View |
| Sunburn | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Modified CTCAE 3.0 | View |
| High blood pressure | SYSTEMATIC_ASSESSMENT | Vascular disorders | Modified CTCAE 3.0 | View |
| Low blood pressure | SYSTEMATIC_ASSESSMENT | Vascular disorders | Modified CTCAE 3.0 | View |
| Pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | Modified CTCAE 3.0 | View |
| Hematoma due to injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Modified CTCAE 3.0 | View |
| Hematoma due to procedure complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Modified CTCAE 3.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Modified CTCAE 3.0 | View |
| Bleeding - spontaneous | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Modified CTCAE 3.0 | View |
| Hematoma - spontaneous | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Modified CTCAE 3.0 | View |
| Bleeding - spontaneous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Modified CTCAE 3.0 | View |