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 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
NCT ID:
NCT01445535
Description:
None
Frequency Threshold:
0
Time Frame:
Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
Study:
NCT01445535
Study Brief:
Phase 1 Trial of Siplizumab and Dose-Adjusted EPOCH-Rituximab in T- and NK-Cell Lymphomas
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 - 3.4 mg/kg | 3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days. | 2 | None | 0 | 3 | 3 | 3 | View |
| Cohort 2 - 4.8 mg/kg | 4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days. | 3 | None | 2 | 3 | 3 | 3 | View |
| Cohort 4 - 15 mg/kg | 15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days. | 4 | None | 1 | 6 | 5 | 6 | View |
| Cohort 3 - 8.5 mg/kg | 8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days. | 3 | None | 2 | 3 | 3 | 3 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | 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 |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE 3.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Bilirubin (hyperbilirubinemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Calcium, serum-low (hypocalcemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Extrapyramidal/involuntary movement/restlessness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Fatigue (asthenia, lethargy, malaise) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 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 |
| Glucose, serum-high (hyperglycemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Hair loss/alopecia (scalp or body) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Heartburn/dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| Laryngeal nerve dysfunction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 3.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 3.0 | View |
| Magnesium, serum-low (hypomagnesemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Mood alteration::Anxiety | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Mucositis/stomatitis (clinical exam)::Oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Mucositis/stomatitis (functional/symptomatic)::Oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal 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 |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 3.0 | View |
| Pain::Abdomen NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Pain::Back | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | View |
| Pain::Bone | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | View |
| Pain::Chest/thorax NOS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Pain::Head/headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Pain::Muscle | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | View |
| Pain::Oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Pain::Skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Pain::Throat/pharynx/larynx | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 3.0 | View |
| Potassium, serum-low (hypokalemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Pruritus/itching | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Sodium, serum-low (hyponatremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Supraventricular and nodal arrhythmia::Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 3.0 | View |
| Supraventricular and nodal arrhythmia::Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 3.0 | View |
| Taste alteration (dysgeusia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Uric acid, serum-high (hyperuricemia) | 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 |
| Creatinine | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Cytokine release syndrome/acute infusion reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE 3.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Dysphagia (difficulty swallowing) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Hemorrhage, GU::Urethra | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 3.0 | View |
| Hemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Nail changes | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Pain::Dental/teeth/peridontal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Pain::Pain NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| Phosphate, serum-low (hypophosphatemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Rigors/chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| Sweating (diaphoresis) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| Syncope (fainting) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Urinary retention (including neurogenic bladder) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 3.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| CD4 count | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 3.0 | View |
| Cardiac troponin I (cTnI) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 3.0 | View |
| Hemorrhage, pulmonary/upper respiratory::Nose | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 3.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Infection (documented clinically or microbiologically) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Abdomen NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Middle ear (otitis media) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Pain::Lymph node | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 3.0 | View |
| Pain::Middle ear | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE 3.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 3.0 | View |
| Albumin, serum-low (hypoalbuminemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 3.0 | View |
| Edema: head and neck | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 3.0 | View |
| Edema: limb | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 3.0 | View |
| Hemorrhage, GI::Oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Ocular surface disease | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE 3.0 | View |
| Pain::Chest wall | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Pain::Extremity-limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | View |
| Pain::Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE 3.0 | View |
| Pain::Joint | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | View |
| Photosensitivity | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Rash: dermatitis associated with radiation::Chemoradiation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Thrombosis/embolism (vascular access-related) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 3.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |