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 @ 6:47 PM
Ignite Modification Date:
2025-12-25 @ 4:18 PM
NCT ID:
NCT00610857
Description:
Includes adverse events that were considered either study treatment-related or unrelated.
Frequency Threshold:
5
Time Frame:
5 years.
Study:
NCT00610857
Study Brief:
Safety and Efficacy of Combination HDI and Anti-CTLA4 for Recurrent Inoperable Stage III or Stage IV 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 |
|---|---|---|---|---|---|---|---|---|
| Interferon Alfa-2b + Tremelimumab (Related and Unrelated AEs) | Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks per cycle. | None | None | 15 | 37 | 37 | 37 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pain, Abdomen NOS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Thyroid function, high (hyperthyroidism, thyrotoxicosis) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (3.0) | View |
| Fatigue (asthenia, lethargy, malaise) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Thrombosis/thrombus/embolism | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, CNS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Supraventricular and nodal arrhythmia, Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Bronchospasm, wheezing | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Secondary Malignancy - possibly related to cancer treatment | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | View |
| GGT (gamma-Glutamyl transpeptidase) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Sweating (diaphoresis) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Rigors/chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fatigue (asthenia, lethargy, malaise) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Dermatology/Skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Hair loss/alopecia (scalp or body) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Pruritus/itching | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Mucositis/stomatitis (clinical exam), Oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Taste alteration (dysgeusia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Edema: limb | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Albumin, serum-low (hypoalbuminemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| CPK (creatine phosphokinase) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Musculoskeletal/Soft Tissue | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Mood alteration, Agitation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy: motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy: sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Mood alteration, Depression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neurology | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Pain, Extremity-limb | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Other | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain, Back | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain, Abdomen NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain, Head/headache | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain, Muscle | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (3.0) | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Mood alteration, Anxiety | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |