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 @ 6:28 PM
Ignite Modification Date:
2025-12-25 @ 3:58 PM
NCT ID:
NCT00812968
Description:
None
Frequency Threshold:
0
Time Frame:
From the first dose of study drug through 28 days after completion of/discontinuation from the study (maximum time on study was 155 weeks).
Study:
NCT00812968
Study Brief:
Study of CC-5013 to Evaluate Safety, Pharmacokinetics and Effectiveness for Japanese Patients With Symptomatic Anemia Associated With Myelodysplastic Syndrome With a Del(5)(q31-33) Abnormality.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Lenalidomide | 10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years). | None | None | 3 | 11 | 11 | 11 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA, Version 10.0 | View |
| Herpes Zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, Version 10.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, Version 10.0 | View |
| Spinal Compression Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA, Version 10.0 | View |
| Liver Function Test Abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, Version 10.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA, Version 10.0 | View |
| Gastric Ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 10.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Basophilia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA, Version 10.0 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA, Version 10.0 | View |
| Lymphadenitis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA, Version 10.0 | View |
| Lymphocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA, Version 10.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 10.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 10.0 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 10.0 | View |
| Dental Caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 10.0 | View |
| Enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 10.0 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 10.0 | View |
| Abdominal Discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 10.0 | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 10.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 10.0 | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 10.0 | View |
| Haemorrhoidal Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 10.0 | View |
| Lip Dry | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 10.0 | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 10.0 | View |
| Periodontitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 10.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 10.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 10.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, Version 10.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, Version 10.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, Version 10.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, Version 10.0 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, Version 10.0 | View |
| Acute Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, Version 10.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, Version 10.0 | View |
| Lymphadenitis Bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, Version 10.0 | View |
| Oral Herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, Version 10.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, Version 10.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, Version 10.0 | View |
| Vulvitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, Version 10.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA, Version 10.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA, Version 10.0 | View |
| Dermatitis Contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA, Version 10.0 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA, Version 10.0 | View |
| Acute Febrile Neutrophilic Dermatosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA, Version 10.0 | View |
| Dry Skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA, Version 10.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA, Version 10.0 | View |
| Erythema Multiforme | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA, Version 10.0 | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, Version 10.0 | View |
| Blood Creatinine Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, Version 10.0 | View |
| Fibrin Degradation Products Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, Version 10.0 | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, Version 10.0 | View |
| Blood Bilirubin Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, Version 10.0 | View |
| Blood Phosphorus Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, Version 10.0 | View |
| Blood Uric Acid Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, Version 10.0 | View |
| Fibrin D Dimer Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, Version 10.0 | View |
| Blood Alkaline Phosphatase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, Version 10.0 | View |
| Blood Lactate Dehydrogenase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, Version 10.0 | View |
| Blood Potassium Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, Version 10.0 | View |
| Blood Pressure Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, Version 10.0 | View |
| Blood Urea Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, Version 10.0 | View |
| Blood Urea Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, Version 10.0 | View |
| International Normalised Ratio Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, Version 10.0 | View |
| Mean Cell Volume Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, Version 10.0 | View |
| Protein Total Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, Version 10.0 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, Version 10.0 | View |
| Muscle Spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, Version 10.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, Version 10.0 | View |
| Bone Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, Version 10.0 | View |
| Musculoskeletal Chest Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, Version 10.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, Version 10.0 | View |
| Myalgia Intercostal | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, Version 10.0 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, Version 10.0 | View |
| Osteoporosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, Version 10.0 | View |
| Periarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, Version 10.0 | View |
| Spinal Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, Version 10.0 | View |
| Spinal Compression Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA, Version 10.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA, Version 10.0 | View |
| Excoriation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA, Version 10.0 | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA, Version 10.0 | View |
| Tooth Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA, Version 10.0 | View |
| Face Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 10.0 | View |
| Injection Site Erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 10.0 | View |
| Non-cardiac Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 10.0 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 10.0 | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 10.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 10.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 10.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA, Version 10.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA, Version 10.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA, Version 10.0 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA, Version 10.0 | View |
| Iron Deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA, Version 10.0 | View |
| Vitamin B12 Deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA, Version 10.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA, Version 10.0 | View |
| Blepharitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA, Version 10.0 | View |
| Conjunctival Haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA, Version 10.0 | View |
| Eye Discharge | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA, Version 10.0 | View |
| Vision Blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA, Version 10.0 | View |
| Vitreous Detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA, Version 10.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 10.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 10.0 | View |
| Upper Respiratory Tract Inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 10.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA, Version 10.0 | View |
| Cervicobrachial Syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA, Version 10.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA, Version 10.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA, Version 10.0 | View |
| Tension | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA, Version 10.0 | View |
| Ear Discomfort | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA, Version 10.0 | View |
| Hepatic Function Abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA, Version 10.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA, Version 10.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA, Version 10.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA, Version 10.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA, Version 10.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA, Version 10.0 | View |
| Eosinophilia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA, Version 10.0 | View |