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 @ 7:33 PM
Ignite Modification Date:
2025-12-25 @ 5:15 PM
NCT ID:
NCT02145403
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse event data were collected up to 100 days after the last dose of carfilzomib. All-cause mortality includes all patients followed for up to three years after their first dose of carfilzomib; total duration of data collection was 6 years with an average duration of 1.8 years.
Study:
NCT02145403
Study Brief:
Phase 1/2 Study of Carfilzomib for the Prevention of Relapse and GVHD in Allo-HCT for Hematologic Malignancies
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Dose Level 1 - Maximum Dose Carfilzomib 20 mg/m^2 IV | Participants in all cohorts were administered 20 mg/m\^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 1: Participants were administered 20 mg/m\^2 of Carfilzomib on days +6 and +7. | 1 | None | 1 | 3 | 3 | 3 | View |
| Dose Level 2 - Maximum Dose Carfilzomib 27 mg/m^2 IV | Participants in all cohorts were administered 20 mg/m\^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 2: Participants were administered 27 mg/m\^2 of Carfilzomib on days +6 and +7. | 2 | None | 2 | 3 | 0 | 3 | View |
| Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2 IV | Participants in all cohorts were administered 20 mg/m\^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 3: Participants were administered 36 mg/m\^2 of Carfilzomib on days +6 and +7. | 18 | None | 25 | 41 | 16 | 41 | View |
| Dose Level 4 - Maximum Dose Carfilzomib 45 mg/m^2 IV | Participants in all cohorts were administered 20 mg/m\^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 4: Participants were administered 45 mg/m\^2 of Carfilzomib on days +6 and +7. | 2 | None | 4 | 4 | 3 | 4 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infections and infestations - Other | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Anaphylaxis | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Blood and lymphatic system disorders - Other | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Colonic hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Corneal ulcer | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Encephalitis infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Erythema multiforme | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Immune system disorders - Other | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Lower gastrointestinal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Papulopustular rash | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Reversible posterior leukoencephalopathy syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Tumor lysis syndrome | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Vascular access complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Ejection fraction decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Immune system disorders - Other | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Papulopustular rash | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Penile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |