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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
NCT ID:
NCT01181258
Description:
Fifteen patients were dosed with the NK cell infusion and therefore were assessed for adverse events. One patient died prior to the NK cell infusion.
Frequency Threshold:
0
Time Frame:
None
Study:
NCT01181258
Study Brief:
Penostatin, Rituximab and Ontak and Allogeneic Natural Killer (NK) Cells for Refractory Lymphoid Malignancies
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Patients Receiving NK Cell Infusion | Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL Rituximab: 375 mg/m\^2 administered intravenously (IV) weekly \* 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK) Interleukin-2: subcutaneously administered 9 million international units (IU) every other day \* 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight \< 45 kilograms, give IL-2 at 5 million units/m2 on same schedule. Natural killer cells: administered intravenously 1.5 to 8 \* 10\^7 cells/kg on Day 0 (day of NK cell infusion) Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion Fludarabine: 25 mg/m\^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through | None | None | 6 | 15 | 15 | 15 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Sepsis | None | Infections and infestations | None | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Bronchospasm | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypertension | None | Cardiac disorders | None | View |
| Thrombotic Thrombocytopenic Purpura | None | Blood and lymphatic system disorders | None | View |
| Febrile Neutropenia | None | Blood and lymphatic system disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute Kidney Injury | None | Renal and urinary disorders | None | View |
| Back/Chest Spasms | None | Musculoskeletal and connective tissue disorders | None | View |
| Capillary Leak Syndrome | None | Vascular disorders | None | View |
| Chemosis, Eye | None | Eye disorders | None | View |
| Chest Pain | None | General disorders | None | View |
| Chills | None | General disorders | None | View |
| Confusion | None | Psychiatric disorders | None | View |
| Creatinine Increased | None | Investigations | None | View |
| Dry Eyes | None | Eye disorders | None | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Edema | None | General disorders | None | View |
| Fever | None | General disorders | None | View |
| Flu-like Symptoms | None | General disorders | None | View |
| Headache | None | Nervous system disorders | None | View |
| Hypertension | None | Vascular disorders | None | View |
| Hypotension | None | Vascular disorders | None | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Infusion Related Reaction | None | General disorders | None | View |
| Injection Site Reaction | None | General disorders | None | View |
| Left Jaw Pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Leg Pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Nasal Congestion | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Neck Pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Neutropenic Fever | None | Blood and lymphatic system disorders | None | View |
| Peripheral Neuropathy | None | Nervous system disorders | None | View |
| Pneumonitis/Pulmonary Infiltrates | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Prolonged QTC Interval | None | Cardiac disorders | None | View |
| Rash/Desquamation | None | Skin and subcutaneous tissue disorders | None | View |
| Tachycardia | None | Cardiac disorders | None | View |
| Tumor Lysis Syndrome | None | Metabolism and nutrition disorders | None | View |
| Tumor Pain | None | General disorders | None | View |
| Upper Extremity Swelling/Edema | None | General disorders | None | View |
| Weight Gain | None | Investigations | None | View |