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 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
NCT ID:
NCT00910858
Description:
None
Frequency Threshold:
5
Time Frame:
The safety analyses were conducted on data collected from the time of first dose of study drug to 30 days after the last dose of study drug.
Study:
NCT00910858
Study Brief:
A Pharmacokinetic And Pharmacodynamic Study Of Oral Lenalidomide (Revlimid) In Subjects With Low- Or Intermediate-1-Risk Myelodysplastic Syndromes
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 10 mg Lenalidomide | Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase. During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure. After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment. | None | None | 10 | 24 | 24 | 24 | View |
| 15 mg Lenalidomide | Participants with low- or intermediate-1-risk MDS were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure. After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment. | None | None | 5 | 15 | 15 | 15 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Costochondritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Pain in limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Transient ischemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Dyspnea NOS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| Gangrene NOS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| Diarrhea NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Vomiting NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Transfusion reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Disease progression NOS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Pneumonia NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Parotitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Sepsis NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| Leukopenia NOS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| Anaemia NOS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| Autoimmune haemolytic anaemia NOS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| Diarrhoea NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Abdominal pain NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Vomiting NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Loose stools | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Barrett's oesophagus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Rash NOS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Urticaria NOS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Dermatitis NOS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Increased tendency to bruise | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Pruritus generalised | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Purpura NOS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Swelling face | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Xeroderma | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Muscle cramp | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Pain in limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Bursa disorder | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Chest wall pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Intervertebral disc herniation | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Muscle tightness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Osteoporosis NOS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Sensation of heaviness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Pain NOS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Gait abnormal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Dyspnoea NOS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Hoarseness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Postnasal drip | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Upper respiratory tract infection NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Urinary tract infection NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Sinusitis NOS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Ear infection NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Body tinea | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Gingival infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Otitis externa NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Respiratory tract infection NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Vaginitis bacterial NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Cerebral atrophy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Cognitive disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Sleep apnoea syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Haemosiderosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Appetite decreased NOS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Haemochromatosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Blood in stool | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Blood urine present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Computerised tomogram abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Faecal occult blood positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Prostatic specific antigen increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Vitamin b12 decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |
| Urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| Azotaemia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| Urine flow decreased | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| Cardiac discomfort | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| Pallor | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| Post procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| Ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Prostatitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Deafness NOS | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (10.0) | View |
| Acquired hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (10.0) | View |
| Hypersensitivity NOS | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (10.0) | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | View |
| Squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | View |