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 @ 9:49 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
NCT ID:
NCT03805932
Description:
None
Frequency Threshold:
0
Time Frame:
Date treatment consent signed to date off study, approximately 11 months and 13 days for the first group, and 4 months and 3 days for the second group.
Study:
NCT03805932
Study Brief:
Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Moxetumomab - Dose Escalation 30 mcg/kg | Participants with Relapsed/Refractory Hairy Cell Leukemia (HCL) or Hairy Cell Leukemia (HCLv) Arm 1 Moxetumomab Pasudotox-tdfk + Rituximab Dose escalation treatment with moxetumomab -pasudotox-tdfk and rituximab Moxetumomab pasudotox-tdfk is administered at 30 ug/Kg intravenous (iv) over 30 min given on days 1, 3, 5 of each cycle. Rituximab will be administered at 375mg/m\^2 iv, 50-400 mg/hour (hr). On cycle 1, Rituximab is given on day -2, on subsequent cycles, Rituximab is given on day 1. | 1 | None | 0 | 3 | 3 | 3 | View |
| Moxetumomab - Dose Expansion 40 mcg/kg | Dose expansion; treatment with moxetumomab -pasudotox-tdfk and Ruxience Arm 1 and Arm 2 Moxetumomab Pasudotox-tdfk + Ruxience Moxetumomab pasudotox-tdfk is administered at 40 ug/Kg intravenous (iv) over 30 min given on days 1, 3, 5 of each cycle. Ruxience will be administered at 375mg/m\^2 iv, 50-400 mg/hour (hr). On cycle 1, Ruxience is given on day -2, on subsequent cycles, Ruxience is given on day 1 (Delta) | 0 | None | 2 | 15 | 15 | 15 | View |
Serious Events(If Any):
Serious Events
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Allergic rhinitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (5.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Bloating | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Bruising | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| CD4 lymphocytes decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| CPK increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Edema face | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Eosinophilia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (5.0) | View |
| Eye disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Eye infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| GGT increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Glucosuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Haptoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Hemoglobinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Hoarseness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypermagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hyperphosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Infusion site extravasation | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Lymphocyte count increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Neck edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Postnasal drip | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Rash acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Scrotal pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (5.0) | View |
| Serum amylase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Skin induration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Superficial thrombophlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |