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 @ 3:00 PM
Ignite Modification Date:
2025-12-25 @ 1:24 PM
NCT ID:
NCT00103259
Description:
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
Frequency Threshold:
5
Time Frame:
Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Study:
NCT00103259
Study Brief:
Bortezomib With or Without Irinotecan in Treating Patients With Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm I (Bortezomib+Irinotecan) | Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | None | None | 17 | 23 | 23 | 23 | View |
| Cross-over Patients | 11 patients crossed over to bortezomib + irinotecan after progressed on bortezomib single agent. Adverse events were reported for the 11 patients while receiving the combination therapy. | None | None | 6 | 11 | 11 | 11 | View |
| Arm II (Bortezomib) | Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan). | None | None | 21 | 41 | 40 | 41 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v3 | View |
| Leukopenia (Leukocytes decreased) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3 | View |
| Neutropenia (Neutrophils decreased) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3 | View |
| Thrombocytopenia (Platelets decreased) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v3 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3 | View |
| Fever w/o neutropenia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v3 | View |
| Constitutional, other | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3 | View |
| Diarrhea w/o prior colostomy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3 | View |
| Stomach, hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3 | View |
| Infection w/ gr3-4 neut, lung | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3 | View |
| Infection w/ gr0-2 neut, lung | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3 | View |
| Infection w/ gr0-2 neut, trachea | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3 | View |
| Infection w/ unknown ANC foreign body | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3 | View |
| Infection w/ gr0-2 neut, blood | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3 | View |
| Glomerular filtration rate decreased | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v3 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3 | View |
| Non-neuropathic generalized weekness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v3 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v3 | View |
| Neuropathy-sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v3 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v3 | View |
| Abdomen, pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3 | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3 | View |
| Pneumonitis/pulmonary infiltrates | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3 | View |
| Vessel injury carotid | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v3 | View |
| Death, NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3 | View |
| Obstruction, small bowel NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v3 | View |
| Leukopenia (Leukocytes decreased) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3 | View |
| Neutropenia (Neutrophils decreased) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3 | View |
| Thrombocytopenia (Platelets decreased) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3 | View |
| Hematologic-other | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v3 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v3 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3 | View |
| Fever w/o neutropenia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v3 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3 | View |
| Constitutional, other | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3 | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3 | View |
| Diarrhea w/o prior colostomy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3 | View |
| Muco/stomatitis by exam, oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3 | View |
| Taste disturbance | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3 | View |
| Alanine aminotransferase increased (ALT, SGPT) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3 | View |
| Aspartate aminotransferase increased (AST, SGOT) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v3 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v3 | View |
| Neuropathy- sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v3 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v3 | View |
| Abdomen, pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3 | View |
| Back, pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v3 | View |
| Neuropathic, pain | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v3 | View |
| Stomach, pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3 | View |
| Allergic rhinitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v3 | View |
| Sweating | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3 | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3 | View |
| Wound, non-infectious | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v3 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3 | View |
| Gastrointestinal disorders (GI)-other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3 | View |
| Infection Gr0-2 neut, upper airway | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v3 | View |
| Bone, pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v3 | View |
| Head/headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v3 | View |
| Muscle, pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v3 | View |
| Neck, pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v3 | View |
| Throat/pharynx/larynx, pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3 | View |
| Urethra, pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v3 | View |
| Voice change/dysarthria | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3 | View |
| Edema head and neck | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3 | View |