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 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
NCT ID:
NCT00109005
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00109005
Study Brief:
Lenalidomide (Revlimid) to Treat Advanced Ocular Melanoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort 1 - 25 mg Lenalidomide (Revlimid) | oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks | None | None | 1 | 8 | 8 | 8 | View |
| Cohort 2 - 5 mg Lenalidomide (Revlimid) | oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks | None | None | 1 | 9 | 9 | 9 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | SYSTEMATIC_ASSESSMENT | Investigations | CTCv3.0 | View |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | SYSTEMATIC_ASSESSMENT | Investigations | CTCv3.0 | View |
| Albumin, serum-low (hypoalbuminemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Investigations | CTCv3.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv3.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv3.0 | View |
| Fatigue (asthenia, lethargy, malaise) | SYSTEMATIC_ASSESSMENT | General disorders | CTCv3.0 | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | SYSTEMATIC_ASSESSMENT | General disorders | CTCv3.0 | View |
| Flu-like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCv3.0 | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Investigations | CTCv3.0 | View |
| Infection with unknown ANC::Lung (pneumonia) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv3.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv3.0 | View |
| Infection with unknown ANC::(Sinus) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv3.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCv3.0 | View |
| Musculoskeletal/Soft tissue - Other (Specify, tingling of hands and R foot) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv3.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv3.0 | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Investigations | CTCv3.0 | View |
| Pain::Head/headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Pain::Muscle | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv3.0 | View |
| Pain::Oral gums | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv3.0 | View |
| Pruritus/itching | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv3.0 | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv3.0 | View |
| Vision-flashing lights/floaters | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv3.0 | View |
| Bilirubin (hyperbilirubinemia) | SYSTEMATIC_ASSESSMENT | Investigations | CTCv3.0 | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Investigations | CTCv3.0 | View |
| hematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv3.0 | View |
| INR (International Normalized Ratio of prothrombin time) | SYSTEMATIC_ASSESSMENT | Investigations | CTCv3.0 | View |
| Urinary frequency/urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv3.0 | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Investigations | CTCv3.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCv3.0 | View |
| Mood alteration::Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCv3.0 | View |
| Pain: Back | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv3.0 | View |
| Pain: Extremity-limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv3.0 | View |
| Pain::Joint | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv3.0 | View |
| Urticaria (hives, welts, wheals) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv3.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv3.0 | View |
| Rash: acne/acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv3.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv3.0 | View |
| Somnolence/depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Sweating (diaphoresis) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv3.0 | View |