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 @ 2:11 PM
Ignite Modification Date:
2025-12-25 @ 12:51 PM
NCT ID:
NCT00923195
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00923195
Study Brief:
Radiation, Chemotherapy, Vaccine and Anti-MART-1 and Anti-gp100 Cells for Patients With Metastatic 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 |
|---|---|---|---|---|---|---|---|---|
| TBI 600cGy + PBL + HD IL-2+gp100:154-162 | Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population). One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses). Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days. | None | None | 2 | 2 | 2 | 2 | View |
| TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L) | Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population). One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses). Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days. | None | None | 1 | 2 | 2 | 2 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Somnolence/depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv3.0 | View |
| Ischemia cerebrovascular | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hearing test abnormal | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCv3.0 | View |
| Hemoglobin decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Leukocyte count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv3.0 | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Skin hypopigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv3.0 | View |
| Rash desquamating | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv3.0 | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv3.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv3.0 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv3.0 | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv3.0 | View |
| Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Serum albumin decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Bilirubin increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Serum phosphate decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Serum sodium decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Blood uric acid increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Uveitis | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv3.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCv3.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv3.0 | View |
| Low urine output | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv3.0 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv3.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv3.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv3.0 | View |
| Colitis, infectious (e.g., Clostridium difficile) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv3.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv3.0 | View |
| Catheter-related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv3.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv3.0 | View |
| Peripheral nerve infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv3.0 | View |
| Anorectal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv3.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Serum calcium decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Serum potassium decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Laryngeal edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv3.0 | View |
| Psychosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |