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 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
NCT ID:
NCT01142232
Description:
None
Frequency Threshold:
5
Time Frame:
up to 5 years
Study:
NCT01142232
Study Brief:
Lenalidomide and High Dose Melphalan Followed by Autologous Stem Cell Transplant in Multiple Myeloma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase I, Dose Level 1 | All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 50 mg given daily day -7 to day +2 | None | None | 0 | 3 | 3 | 3 | View |
| Phase I, Dose Level 2 | All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 75 mg given daily day -7 to day +2 | None | None | 1 | 4 | 4 | 4 | View |
| Phase II | All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2 | None | None | 11 | 44 | 44 | 44 | View |
| Phase I, Dose Level 3 | All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 100 mg given daily day -7 to day +2 | None | None | 2 | 3 | 3 | 3 | View |
| Phase I, Dose Level 4 | All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2 | None | None | 3 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Colonic obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Infections and infestations - Other | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Lung infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Upper respiratory infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Investigations - Other | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Metabolism and nutrition disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Bronchopulmonary hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Thromboembolic event | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Cardiac disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Chest pain - cardiac | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Ear and labyrinth disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (4.0) | View |
| Hearing impaired | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (4.0) | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (4.0) | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (4.0) | View |
| Eye disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.0) | View |
| Eye pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.0) | View |
| Retinal detachment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.0) | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Bloating | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Gastroesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Gastrointestinal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Hemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| INR increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hyperkalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hyperuricemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypocalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypoglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypomagnesemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypophosphatemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Chest wall pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Musculoskeletal and connective tissue disorder - Other | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Osteonecrosis of jaw | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Dysphasia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Paresthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Peripheral motor neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Confusion | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Urinary frequency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Urinary urgency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Breast pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| Erectile dysfunction | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| Allergic rhinitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Bronchopulmonary hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Hiccups | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Postnasal drip | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Respiratory, thoracic and mediastinal disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Sleep apnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Sore throat | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Wheezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Pain of skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Rash acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Scalp pain | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Skin and subcutaneous tissue disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Skin hyperpigmentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Superficial thrombophlebitis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Thromboembolic event | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Vascular disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Mucositis oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Oral dysesthesia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Oral pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Edema limbs | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Flu like symptoms | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General disorders and administration site conditions - Other | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Localized edema | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Bronchial infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Infections and infestations - Other | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Lung infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Upper respiratory infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |