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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
NCT ID:
NCT00307294
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00307294
Study Brief:
Thalidomide and Doxil® in Patients With Androgen Independent Prostate Cancer (AIPC)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Thalidomide and Doxil | Combination of Thalidomide and Doxil Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days | None | None | 9 | 39 | 39 | 39 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| INR (International Normalized Ratio of prothrombin time) | None | Investigations | None | View |
| Dehydration | None | Metabolism and nutrition disorders | None | View |
| Arthritis (non-septic) | None | Musculoskeletal and connective tissue disorders | None | View |
| Pain - Other | None | General disorders | None | View |
| Pain, Intestine | None | Gastrointestinal disorders | None | View |
| Pain, Pelvis | None | Gastrointestinal disorders | None | View |
| Dyspnea (shortness of breath) | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Edema: limb | None | General disorders | None | View |
| Pain, Bone | None | Musculoskeletal and connective tissue disorders | None | View |
| Atelectasis | None | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Auditory/Ear - Other | None | Ear and labyrinth disorders | None | View |
| Leukocytes (total WBC) | None | Investigations | None | View |
| Lymphopenia | None | Investigations | None | View |
| Rash: hand-foot skin reaction | None | Skin and subcutaneous tissue disorders | None | View |
| Urticaria (hives, welts, wheals) | None | Skin and subcutaneous tissue disorders | None | View |
| Anorexia | None | Metabolism and nutrition disorders | None | View |
| Constipation | None | Gastrointestinal disorders | None | View |
| Dehydration | None | Metabolism and nutrition disorders | None | View |
| Diarrhea | None | Gastrointestinal disorders | None | View |
| Dry mouth/salivary gland (xerostomia) | None | Gastrointestinal disorders | None | View |
| Dysphagia (difficulty swallowing) | None | Gastrointestinal disorders | None | View |
| Gastrointestinal - Other | None | Gastrointestinal disorders | None | View |
| Mucositis/stomatitis (clinical exam), Oral cavity | None | Gastrointestinal disorders | None | View |
| Mucositis/stomatitis (functional/symptomatic), Oral cavity | None | Gastrointestinal disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Taste alteration (dysgeusia) | None | Gastrointestinal disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Hemorrhage, GU, Urinary NOS | None | Renal and urinary disorders | None | View |
| Hemorrhage, pulmonary/upper respiratory, Nose | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Hemorrhage/Bleeding - Other | None | Blood and lymphatic system disorders | None | View |
| Infection with Grade 3 or 4 neutrophils , Lung (pneumonia) | None | Infections and infestations | None | View |
| Infection - Other | None | Infections and infestations | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils, Dental-tooth | None | Infections and infestations | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia) | None | Infections and infestations | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils, Oral cavity-gums (gingivitis) | None | Infections and infestations | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils, Sinus | None | Infections and infestations | None | View |
| Infection with unknown ANC, Sinus | None | Infections and infestations | None | View |
| Edema: limb | None | General disorders | None | View |
| Lymphatics - Other | None | Blood and lymphatic system disorders | None | View |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | None | Investigations | None | View |
| Albumin, serum-low (hypoalbuminemia) | None | Metabolism and nutrition disorders | None | View |
| Alkaline phosphatase | None | Investigations | None | View |
| Calcium, serum-high (hypercalcemia) | None | Metabolism and nutrition disorders | None | View |
| Calcium, serum-low (hypocalcemia) | None | Metabolism and nutrition disorders | None | View |
| Potassium, serum-high (hyperkalemia) | None | Metabolism and nutrition disorders | None | View |
| Sodium, serum-low (hyponatremia) | None | Metabolism and nutrition disorders | None | View |
| Muscle weakness, generalized or specific area (not due to neuropathy), Extraocular | None | Musculoskeletal and connective tissue disorders | None | View |
| Muscle weakness, generalized or specific area (not due to neuropathy), Extremity-lower | None | Musculoskeletal and connective tissue disorders | None | View |
| Musculoskeletal/Soft Tissue - Other | None | Musculoskeletal and connective tissue disorders | None | View |
| Dizziness | None | Nervous system disorders | None | View |
| Extrapyramidal/involuntary movement/restlessness | None | Nervous system disorders | None | View |
| Memory impairment | None | Nervous system disorders | None | View |
| Mood alteration, Anxiety | None | Psychiatric disorders | None | View |
| Mood alteration, Depression | None | Psychiatric disorders | None | View |
| Neurology - Other | None | Nervous system disorders | None | View |
| Neuropathy: motor | None | Nervous system disorders | None | View |
| Neuropathy: sensory | None | Nervous system disorders | None | View |
| Somnolence/depressed level of consciousness | None | Nervous system disorders | None | View |
| Tremor | None | Nervous system disorders | None | View |
| Ocular/Visual - Other | None | Eye disorders | None | View |
| Vision-blurred vision | None | Eye disorders | None | View |
| Watery eye (epiphora, tearing) | None | Eye disorders | None | View |
| Pain - Other | None | General disorders | None | View |
| Pain, Abdomen NOS | None | Gastrointestinal disorders | None | View |
| Pain, Back | None | Musculoskeletal and connective tissue disorders | None | View |
| Pain, Bone | None | Musculoskeletal and connective tissue disorders | None | View |
| Pain, Chest wall | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pain, Extremity-limb | None | Musculoskeletal and connective tissue disorders | None | View |
| Pain, Face | None | General disorders | None | View |
| Pain, Head/headache | None | Nervous system disorders | None | View |
| Pain, Joint | None | Musculoskeletal and connective tissue disorders | None | View |
| Pain, Oral cavity | None | Gastrointestinal disorders | None | View |
| Pain, Pelvis | None | Gastrointestinal disorders | None | View |
| Pain, Throat/pharynx/larynx | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Atelectasis | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Dyspnea (shortness of breath) | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Edema, larynx | None | General disorders | None | View |
| Nasal cavity/paranasal sinus reactions | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pleural effusion (non-malignant) | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary/Upper Respiratory - Other | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Incontinence, urinary | None | Renal and urinary disorders | None | View |
| Renal failure | None | Renal and urinary disorders | None | View |
| Renal/Genitourinary - Other | None | Renal and urinary disorders | None | View |
| Urinary frequency/urgency | None | Renal and urinary disorders | None | View |
| Urinary retention (including neurogenic bladder) | None | Renal and urinary disorders | None | View |
| Urine color change | None | Renal and urinary disorders | None | View |
| Platelets | None | Investigations | None | View |
| Cardiac Arrhythmia - Other | None | Cardiac disorders | None | View |
| Palpitations | None | Cardiac disorders | None | View |
| Supraventricular and nodal arrhythmia, Sinus bradycardia | None | Cardiac disorders | None | View |
| Supraventricular and nodal arrhythmia, Supraventricular tachycardia | None | Cardiac disorders | None | View |
| Hypotension | None | Vascular disorders | None | View |
| Constitutional Symptoms - Other | None | General disorders | None | View |
| Fatigue (asthenia, lethargy, malaise) | None | General disorders | None | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | None | General disorders | None | View |
| Insomnia | None | Psychiatric disorders | None | View |
| Rigors/chills | None | General disorders | None | View |
| Sweating (diaphoresis) | None | Skin and subcutaneous tissue disorders | None | View |
| Weight gain | None | Investigations | None | View |
| Weight loss | None | Investigations | None | View |
| Dermatology/Skin - Other | None | Skin and subcutaneous tissue disorders | None | View |
| Dry skin | None | Skin and subcutaneous tissue disorders | None | View |
| Hair loss/alopecia (scalp or body) | None | Skin and subcutaneous tissue disorders | None | View |
| Hyperpigmentation | None | Skin and subcutaneous tissue disorders | None | View |
| Pruritus/itching | None | Skin and subcutaneous tissue disorders | None | View |
| Rash/desquamation | None | Skin and subcutaneous tissue disorders | None | View |
| Hot flashes/flushes | None | Vascular disorders | None | View |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Blood/Bone Marrow - Other | None | Blood and lymphatic system disorders | None | View |
| Hemoglobin | None | Blood and lymphatic system disorders | None | View |
| Neutrophils/granulocytes (ANC/AGC) | None | Investigations | None | View |