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 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
NCT ID:
NCT00416351
Description:
None
Frequency Threshold:
0
Time Frame:
2 years
Study:
NCT00416351
Study Brief:
Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 4 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. | 1 | None | 0 | 1 | 1 | 1 | View |
| 8 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. | 3 | None | 1 | 3 | 3 | 3 | View |
| 13.2 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. | 3 | None | 1 | 4 | 4 | 4 | View |
| 20 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. | 12 | None | 13 | 17 | 17 | 17 | View |
| 28 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. | 4 | None | 4 | 4 | 4 | 4 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Calcium, high (hypercalcemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Fever (in the absence of neutropenia) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Glucose, low (hypoglycemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hemorrhage/Bleeding, other | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Inf norm ANC/gr1/2 neut-Bronchitis NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Inf norm ANC/gr1/2 neut-Joint | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Inf unknown ANC-Cellulitis(skin) | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Inf unknown ANC-Pneumonia(lung) | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection w/ Gr 3/4 neut, Blood | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection, other | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Mucositis (Clin exam)- Oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Ocular/Visual - Other (specify) | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Odor (patient odor) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pain - Other (specify) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain - Throat/pharynx/larynx | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Pleural effusion (non-malig) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Rigors/chills | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Sodium, low (hyponatremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Uric acid, high (hyperuricemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fatigue (asthenia, lethargy, malaise) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pain - Other (specify) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain - Throat/pharynx/larynx | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Infection, other | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Pain - Oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Pleural effusion (non-malig) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulm/upp respiratory - Other (spec) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Albumin, low (hypoalbuminemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| ALT, SGPT | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| AST, SGOT | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Bilirubin (hyperbilirubinemia) | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Calcium, high (hypercalcemia) | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dermatology/Skin, other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Edema: Limb | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Glucose, high (hyperglycemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Infection w/ Gr 3/4 neut, Skin (cellulites) | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| INR | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Magnesium, high (hypermagnesemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Pain - Back | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain - Bone | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain - Tumor pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Phosphate, low (hypophosphatemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Potassium, high (hyperkalemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Potassium, low (hypokalemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rigors/chills | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Sodium, low (hyponatremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Magnesium, low (hypomagnesemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Mucositis (Clin exam)- Oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Ophthalmoplegia/diplopia (double vision) | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |