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 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
NCT ID:
NCT00184002
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Study:
NCT00184002
Study Brief:
Doxorubicin (Doxil) Combined With Rituxan, Cyclophosphamide, Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| DR-COP | On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5. On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5 * 1 cycle = 21 days. * Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles. Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min. Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min. Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum). Prednisone 100 mg po days 1-5. Cycle 2 until study completion Doxil 40 mg/m2 iv day 1 Rituxan 375 mg/m2 iv day 1 Cyclophosphamide 750 mg/m2 iv day 1 | 3 | None | 35 | 68 | 27 | 68 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain or cramping | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Bilirubin | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| Cardiac left ventricular function | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Cardiac troponin I (cTnl) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Diarrhea patients without colostomy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Fatigue (lethargy, malaise, asthenia) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Hand-foot skin reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Ileus (or neuroconstipation) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Infection without neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Melena/GI bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Myalgia (muscle pain) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Neuropathy-sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Pleural effusion (non-malignant) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Pneumonitis/pulmonary infiltrates | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| SGOT (AST) (serum glutamic oxaloacetic transaminase) | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| SGPT (ALT) (serum glutamic pyruvic transaminase) | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| Stomatitis/pharingitis (oral/pharyngeal mucositis) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Tumor lysis syndrome | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Ureteral obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain or cramping | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| Alkalosis (metabolic or respiratory) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Arthralgia (joint pain) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Ascites (non-malignant) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Cardiac left ventricular function | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Chest pain (non-cardiac and non-pleuritic) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Diarrhea patients without colostomy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Dizziness/lightheadedness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Dyspepsia/heartburn | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Dysphagia, esophagitis, odynophagia (painful swallowing) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Dysuria (painful urination) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Fatigue (lethargy, malaise, asthenia) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Hand-foot skin reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Hemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Hemorrhage/bleeding | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (2.0) | View |
| Hot flashes/flushes | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (2.0) | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypercholesterolemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypermagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Ileus (or neuroconstipation) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Infection without neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (2.0) | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Melena/GI bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Mood alteration-anxiety, agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (2.0) | View |
| Mood alteration-depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (2.0) | View |
| Mouth dryness | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Muscle weakness (not due to neuropathy) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Myalgia (muscle pain) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Neuropathy-motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Neuropathy-sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Pain due to radiation | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| SGOT (AST) (serum glutamic oxaloacetic transaminase) | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| Skin-Laate RT Morbidity Scoring | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (2.0) | View |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Sweating (eiaphoresis) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Taste disturbance (dysgeusia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Thrombosis/embolism | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Urinary frequency/urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Vision-blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Wound-infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Pigmentation changes (e.g., vitiligo) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Pleural Effusion (non-malignant) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Rigors, chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Sense of smell | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| SGPT (ALT) (serum glutamic pyruvic transaminase) | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Bilirubin | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |