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 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
NCT ID:
NCT00863369
Description:
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Frequency Threshold:
0
Time Frame:
Adverse events occurred over a period of 3 years.
Study:
NCT00863369
Study Brief:
Bortezomib and Gemcitabine in Treating Patients With Relapsed B-Cell Non-Hodgkin Lymphoma
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 Tx Schema I -1 - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m2 | Patients receive 1.0 mg/m2 of velcade IV days 1, 4, 8, 11, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. | 4 | None | 3 | 5 | 5 | 5 | View |
| Dose Level 4B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 800 mg/m2 | Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. | 3 | None | 0 | 3 | 3 | 3 | View |
| Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2 | Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 1000 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. | 4 | None | 0 | 6 | 6 | 6 | View |
| Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2, Rituximab 375 mg/m2 | Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours 375 mg/m2 of rituximab IV on days 1 and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. | 10 | None | 4 | 11 | 11 | 11 | View |
| Dose Level 1 Tx Schema I - Velcade 1.0 mg/m2, Gemcitabine 1000 mg/m2 | Patients receive 1.0 mg/m2 of velcade IV days 1, 4, 8, 11, and 1000 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. | 3 | None | 3 | 4 | 4 | 4 | View |
| Dose Level 3B Tx Schema II - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m2 | Patients receive 1.0 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. | 4 | None | 3 | 4 | 4 | 4 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Supraventricular and nodal arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra10.0 | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra9.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Infection with unknown ANC | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Neutrophils/granulocytes (ANC/AGC) | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Platelets | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Pneumonitis/pulmonary infiltrates | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Pulmonary/Upper Respiratory - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Thrombosis/thrombus/embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra10.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dry mouth/salivary gland (xerostomia) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Dysphagia (difficulty swallowing) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Heartburn/dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Hemorrhage, GI | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Obstruction, GI | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Constitutional Symptoms - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Death not associated with CTCAE term | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Edema:limb | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Fatigue (asthenia, lethargy, malaise) | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Flu-like syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Injection site reaction/extravasation changes | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Pain - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Rigors/chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Allergic reaction/hypersensitivity (including drug fever) | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | meddra9.0 | View |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra9.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Viral hepatitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra9.0 | View |
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra9.0 | View |
| Prolonged chest tube drainage or air leak after pulmonary resection | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra10.0 | View |
| Wound complication, non-infectious | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra9.0 | View |
| AGC | NON_SYSTEMATIC_ASSESSMENT | Investigations | COH | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Alkaline phosphatase | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Bilirubin (hyperbilirubinemia) | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Cholesterol, serum-high (hypercholesteremia) | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Coagulation - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Creatinine | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| FEV(1) | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Leukocytes (total WBC) | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Metabolic/Laboratory - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Neutrophils/granulocytes (ANC/AGC) | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Platelets | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Vital capacity | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Weight loss | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Acidosis (metabolic or respiratory) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Albumin, serum-low (hypoalbuminemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Alkalosis (metabolic or respiratory) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Calcium, serum-high (hypercalcemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Calcium, serum-low (hypocalcemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Glucose, serum-high (hyperglycemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Glucose, serum-low (hypoglycemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Magnesium, serum-high (hypermagnesemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Magnesium, serum-low (hypomagnesemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Phosphate, serum-low (hypophosphatemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Potassium, serum-high (hyperkalemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Potassium, serum-low (hypokalemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Sodium, serum-low (hyponatremia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Triglyceride, serum-high (hypertriglyceridemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Uric acid, serum-high (hyperuricemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra10.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra9.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Extrapyramidal/involuntary movement/restlessness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Memory impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Neurology - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Neuropathy: motor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Neuropathy: sensory | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Somnolence/depressed level of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Taste alteration (dysgeusia) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Confusion | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra9.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra9.0 | View |
| Mood alteration | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra9.0 | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra10.0 | View |
| Renal/Genitourinary - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra9.0 | View |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | View |
| Dyspnea (shortness of breath) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | View |
| Hemorrhage, pulmonary/upper respiratory | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | View |
| Hiccoughs (hiccups, singultus) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Pulmonary fibrosis (radiographic changes) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Pulmonary/Upper Respiratory - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | View |
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Dermatology/Skin - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Hair loss/alopecia (scalp or body) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Induration/fibrosis (skin and subcutaneous tissue) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Nail changes | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Pruritus/itching | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Rash/desquamation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Skin breakdown/decubitus ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Sweating (diaphoresis) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra9.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra9.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra9.0 | View |
| Phlebitis (including superficial thrombosis) | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra10.0 | View |
| Thrombosis/thrombus/embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra9.0 | View |
| Vascular - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra10.0 | View |
| Blood/Bone Marrow - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Hemoglobin | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Left ventricular diastolic dysfunction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra10.0 | View |
| Supraventricular and nodal arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| Hearing: patients without baseline audiogram and not enrolled in a monitoring program | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | meddra9.0 | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | meddra9.0 | View |
| Keratitis (corneal inflammation/corneal ulceration) | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | meddra9.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Distension/bloating, abdominal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |