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 @ 4:47 PM
Ignite Modification Date:
2025-12-25 @ 2:33 PM
NCT ID:
NCT01105650
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT01105650
Study Brief:
Allogeneic Natural Killer (NK) Cells for Ovarian, Fallopian Tube, Peritoneal and Metastatic Breast Cancer
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 1: CsA | Fludarabine: Administered intravenously, 25 mg/m\^2, days -6 through -2 (5 days). Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4. Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14 Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10\^7 cells/kg will be given. Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m\^2 3 times per week for 6 doses). | None | None | 3 | 3 | 3 | 3 | View |
| Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2 | Fludarabine: Administered intravenously, 25 mg/m\^2, days -6 through -2 (5 days). Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4. Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14 Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10\^7 cells/kg will be given. Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m\^2 3 times per week for 6 doses). Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9. | None | None | 3 | 3 | 3 | 3 | View |
| Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2 | Fludarabine: Administered intravenously, 25 mg/m\^2, days -6 through -2 (5 days). Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4. Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14 Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10\^7 cells/kg will be given. Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m\^2 3 times per week for 6 doses). Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9 | None | None | 5 | 7 | 7 | 7 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hearing impairmed | None | Ear and labyrinth disorders | None | View |
| Vestibular disorder | None | Ear and labyrinth disorders | None | View |
| Blurred vision | None | Eye disorders | None | View |
| Acute kidney injury | None | Renal and urinary disorders | None | View |
| Hypertension | None | Vascular disorders | None | View |
| Atrial flutter | None | Cardiac disorders | None | View |
| Fever | None | General disorders | None | View |
| Respiratory failure | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Abdominal pain | None | Gastrointestinal disorders | None | View |
| Death NOS | None | General disorders | None | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal 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 |
| Ascites | None | Gastrointestinal disorders | None | View |
| Capillary leak syndrome | None | Vascular disorders | None | View |
| Chills | None | General disorders | None | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Edema | None | General disorders | None | View |
| Fever | None | General disorders | None | View |
| Headache | None | Nervous system disorders | None | View |
| Hypertension | None | Vascular disorders | None | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pleural effusion | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Rash/Desquamation | None | Skin and subcutaneous tissue disorders | None | View |
| Infusion related reaction | None | General disorders | None | View |
| Injection Site Reaction | None | General disorders | None | View |
| Neutropenic fever | None | Blood and lymphatic system disorders | None | View |
| Pneumonitis/Pulmonary Infiltrates | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Depressed level of consciousness | None | Nervous system disorders | None | View |
| Hypotension | None | Vascular disorders | None | View |
| Atrial fibrillation | None | Cardiac disorders | None | View |
| Confusion/Disoriented | None | Nervous system disorders | None | View |
| Double vision | None | Eye disorders | None | View |
| Foot pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Strange dreams | None | Nervous system disorders | None | View |
| Creatinine Increased | None | Investigations | None | View |
| Hypokalemia | None | Metabolism and nutrition disorders | None | View |
| Body aches | None | General disorders | None | View |
| Night sweats | None | General disorders | None | View |
| Weight gain | None | Investigations | None | View |
| Fall | None | Injury, poisoning and procedural complications | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Pain with stools | None | Gastrointestinal disorders | None | View |
| Hallucinations | None | Nervous system disorders | None | View |
| Dizziness | None | Nervous system disorders | None | View |
| Hearing loss | None | Ear and labyrinth disorders | None | View |