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 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
NCT ID:
NCT00001832
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00001832
Study Brief:
Lymphocyte Re-infusion During Immune Suppression to Treat 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 |
|---|---|---|---|---|---|---|---|---|
| Abl Cells IV+Low Dose IV IL-2 (Initial) | Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses) | None | None | 0 | 3 | 3 | 3 | View |
| Abl Cells IV+High Dose IV IL-2 (Initial) | Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) | None | None | 0 | 6 | 6 | 6 | View |
| Abl Cells IA+MTD IL-2 (MART-1 Reactive) | Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells | None | None | 1 | 8 | 8 | 8 | View |
| Abl Cells IV + SQ IL-2 With GCSF | Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + granulocyte colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified | None | None | 0 | 6 | 6 | 6 | View |
| Abl Cells IV + SQ IL-2 With GCSF (no Reactivity) | Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity | None | None | 1 | 2 | 2 | 2 | View |
| Abl Cells IV + Cyclophosphamide 30 mg/kg | Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV) | None | None | 0 | 3 | 3 | 3 | View |
| Abl Cells IV + Cyclophosphamide 60 mg/kg | Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) | None | None | 0 | 3 | 3 | 3 | View |
| Abl Cells IV + MTD IL-2 | Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery) | None | None | 9 | 51 | 50 | 51 | View |
| Abl Cells IA + MTD (Prior Cells IV on 6) | Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF) | None | None | 0 | 4 | 4 | 4 | View |
| Abl Cells IA + MTD IL-2 | Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) | None | None | 2 | 7 | 7 | 7 | View |
| Abl Cells IV + MTD IL-2 no GCSF | Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen) | None | None | 0 | 6 | 6 | 6 | View |
| Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive) | Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells | None | None | 0 | 1 | 1 | 1 | View |
| Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive) | Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells | None | None | 0 | 7 | 7 | 7 | View |
| Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive) | Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with granulocyte colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m\^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells | None | None | 1 | 3 | 3 | 3 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| General symptom | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Infection (documented clinically or microbiologically) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Infection/Febrile neutropenia (infection without neutropenia) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Hallucinations | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Leukoencephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Neurological disorder NOS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv2.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv2.0 | View |
| Thrombotic microangiopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Disseminated intravascular coagulation | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Infection (documented clinically or microbiologically) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Peripheral ischemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv2.0 | View |
| left ventricular dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hemoglobin decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Leukocyte count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Serum albumin decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Bilirubin increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Serum calcium decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Serum magnesium decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Serum phosphate decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| INR increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Thrombotic microangiopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Pigmentation changes (e.g., vitiligo) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Rash desquamating | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Infection (documented clinically or microbiologically) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Serum potassium increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Serum potassium decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Serum sodium decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Serum triglycerides increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Blood uric acid increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Neurological disorder NOS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv2.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Rectal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Tumor pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCv2.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Respiratory disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Irregular menstruation | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCv2.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Rectal bleeding/hematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Catheter-related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Somnolence/depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Petechiae | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Low urine output | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv2.0 | View |
| Capillary leak syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv2.0 | View |
| Serum magnesium increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Serum calcium increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCv2.0 | View |
| Hallucinations | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| General symptom | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Autoimmune disorder | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCv2.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Hearing loss | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCv2.0 | View |
| Psychosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Hemorrhage nasal | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |