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 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
NCT ID:
NCT04682405
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events were collected from first dose of study treatment through D+30 post autologous hematopoietic cell transplant (auto-HCT). The median follow-up time was 47 days (full range 1-58 days). All-cause mortality was collected from start of treatment through study completion. The median follow-up time was 242 days (full range 1-536 days).
Study:
NCT04682405
Study Brief:
Uproleselan (GMI-1271) for GI Toxicity Prophylaxis During Melphalan-Conditioned Autologous Hematopoietic Cell Transplantation (Auto-HCT) for Multiple Myeloma (MM)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo + Standard of Care Melphalan | Patients will receive six doses of placebo intravenously. The doses will begin the evening of Day -3 and continue every 12 hours through the morning of Day 0, prior to hematopoietic stem cell transplant (auto-HCT). On the evening of Day -2, patients also receive one dose of standard of care Melphalan intravenously. | 3 | None | 5 | 25 | 25 | 25 | View |
| Uproleselan + Standard of Care Melphalan | Patients will receive six doses of Uproleselan intravenously. The doses will begin the evening of Day -3 and continue every 12 hours through the morning of Day 0, prior to hematopoietic stem cell transplant (auto-HCT). On the evening of Day -2, patients also receive one dose of standard of care Melphalan intravenously. | 2 | None | 5 | 26 | 26 | 26 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Lung Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Skin Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (Unspecified) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (Unspecified) | View |
| Sinus Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (Unspecified) | View |
| Supraventricular Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (Unspecified) | View |
| Ear Pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (Unspecified) | View |
| Adrenal Insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (Unspecified) | View |
| Eye Disorders - other | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| Blurred Vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| Extraocular Muscle Paresis | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| Periorbital Edema | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Bloating | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Esophageal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Esophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Gastric Hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Gastroesophageal Reflux Disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Hemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Typhlitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Localized Edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Edema Limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Facial Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Generalized Edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Infusion Site Extravasation | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Neck Edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Non-cardiac Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Allergic Reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (Unspecified) | View |
| Enterocolitis Infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Lung Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Otitis Externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Papulopustular Rash | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Skin Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Thrush | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Bruising | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (Unspecified) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (Unspecified) | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| INR increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Lymphocyte count increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hypermagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hyperphosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hyperuricemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Musculoskeletal and Connective Tissue Disorder - other | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Bone Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Generalized Muscle Weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Muscle Cramp | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Neck Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Pain in Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Neoplasms benign, malignant, and unspecified (incl cysts and polyps) - other | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | View |
| Nervous System Disorders - other | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Peripheral Sensory Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Vasovagal Reaction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Psychiatric Disorders - other | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Hallucinations | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (Unspecified) | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (Unspecified) | View |
| Urinary Retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (Unspecified) | View |
| Reproductive System and Breast Disorders - other | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (Unspecified) | View |
| Allergic Rhinitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Nasal Congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Postnasal Drip | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Pulmonary Edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Sinus Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Sore Throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Skin and Subcutaneous Tissue Disorders - other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Rash Maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Hot Flashes | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (Unspecified) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (Unspecified) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (Unspecified) | View |
| Vision Decreased | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| Gastrointestinal Disorders - other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Oral Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Proctitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Infections and Infestations - other | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Testicular Pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (Unspecified) | View |
| Respiratory, Thoracic, and Mediastinal Disorders - other | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |