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 @ 6:29 PM
Ignite Modification Date:
2025-12-25 @ 3:59 PM
NCT ID:
NCT00062868
Description:
Zeros in the number of participants at risk for Other/Serious Adverse Events and the number of participants at risk for All-Cause Mortality are due to no participants treated at those arms/groups.
One participant in the LMP1/2 CTLs (ALCI) - Group A Expansion was enrolled to this arm/group twice. All adverse event data is included for this participant regardless of enrollment.
Frequency Threshold:
0
Time Frame:
Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 6 weeks after the last dosing of the study drug/biologic.
Study:
NCT00062868
Study Brief:
LMP-specific T-cells for Patients With Relapsed EBV-positive Lymphoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| LMP2A CTLs (ALASCER) - Group A DL1 | Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x10\^7 cells/m2, Day14: 2 x 10\^7 cells/m2). | 2 | None | 2 | 3 | 3 | 3 | View |
| LMP2A CTLs (ALASCER) - Group A DL2 | Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10\^7 cells/m2, Day14: 1 x 10\^8 cells/m2). | 3 | None | 1 | 6 | 6 | 6 | View |
| LMP2A CTLs (ALASCER) - Group A DL3 | Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10\^8 cells/m2, Day14: 2 x 10\^8 cells/m2). | 0 | None | 0 | 3 | 3 | 3 | View |
| LMP2A CTLs (ALASCER) - Group B DL1 | Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10\^7 cells/m2, Day14: 2 x 10\^7 cells/m2). | 2 | None | 1 | 3 | 3 | 3 | View |
| LMP2A CTLs (ALASCER) - Group B DL2 | Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10\^7 cells/m2, Day14: 1 x 10\^8 cells/m2). | 2 | None | 0 | 3 | 3 | 3 | View |
| LMP2A CTLs (ALASCER) - Group B DL3 | Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10\^8 cells/m2, Day14: 2 x 10\^8 cells/m2). | 0 | None | 0 | 0 | 0 | 0 | View |
| LMP2A CTLs (ALASCER) - Group C DL1 | Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10\^7 cells/m2, Day14: 2 x 10\^7 cells/m2). | 3 | None | 1 | 4 | 4 | 4 | View |
| LMP2A CTLs (ALASCER) - Group C DL2 | Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10\^7 cells/m2, Day14: 1 x 10\^8 cells/m2). | 0 | None | 0 | 0 | 0 | 0 | View |
| LMP2A CTLs (ALASCER) - Group C DL3 | Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10\^8 cells/m2, Day14: 2 x 10\^8 cells/m2). | 0 | None | 0 | 0 | 0 | 0 | View |
| LMP1/2 CTLs (ALCI) - Group A DL1 | Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10\^7 cells/m2, Day14: 2 x 10\^7 cells/m2). | 0 | None | 0 | 3 | 3 | 3 | View |
| LMP1/2 CTLs (ALCI) - Group A DL2 | Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10\^7 cells/m2, Day14: 1 x 10\^8 cells/m2). | 1 | None | 1 | 4 | 4 | 4 | View |
| LMP1/2 CTLs (ALCI) - Group A DL3 | Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10\^8 cells/m2, Day14: 2 x 10\^8 cells/m2). | 1 | None | 1 | 5 | 5 | 5 | View |
| LMP1/2 CTLs (ALCI) - Group B DL1 | Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10\^7 cells/m2, Day14: 2 x 10\^7 cells/m2). | 0 | None | 0 | 3 | 3 | 3 | View |
| LMP1/2 CTLs (ALCI) - Group B DL2 | Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10\^7 cells/m2, Day14: 1 x 10\^8 cells/m2). | 0 | None | 1 | 3 | 3 | 3 | View |
| LMP1/2 CTLs (ALCI) - Group B DL3 | Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10\^8 cells/m2, Day14: 2 x 10\^8 cells/m2). | 0 | None | 0 | 3 | 3 | 3 | View |
| LMP1/2 CTLs (ALCI) - Group C DL1 | Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10\^7 cells/m2, Day14: 2 x 10\^7 cells/m2). | 0 | None | 1 | 3 | 3 | 3 | View |
| LMP1/2 CTLs (ALCI) - Group C DL2 | Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10\^7 cells/m2, Day14: 1 x 10\^8 cells/m2). | 2 | None | 0 | 3 | 3 | 3 | View |
| LMP1/2 CTLs (ALCI) - Group C DL3 | Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10\^8 cells/m2, Day14: 2 x 10\^8 cells/m2). | 1 | None | 1 | 4 | 4 | 4 | View |
| LMP1/2 CTLs (ALCI) - Group A Expansion | Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10\^7 cells/m2, Day14: 2 x 10\^7 cells/m2). | 7 | None | 3 | 16 | 16 | 16 | View |
| LMP1/2 CTLs (ALCI) - Group B Expansion | Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10\^7 cells/m2, Day14: 2 x 10\^7 cells/m2). | 0 | None | 0 | 2 | 2 | 2 | View |
| LMP1/2 CTLs (ALCI) - Group C Expansion | Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10\^7 cells/m2, Day14: 2 x 10\^7 cells/m2). | 1 | None | 1 | 3 | 3 | 3 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nodal/junctional arrhythmia/dysrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Supraventricular arrhythmias (SVT/atrial fibrillation/flutter) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Cardiac-ischemia/infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Fatigue (lethargy, malaise, asthenia) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Uticaria (hives, welts, wheals) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Wound-Infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Bilirubin | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| SGOT (AST) (serum glutamic oxaloacetic transaminase) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Infection without neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Dizziness/lightheadedness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Neuropathy - Motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Adult respiratory distress syndrome (ARDS) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Pulmonary-Other:pulmonaryembolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (2.0) | View |
| Secondary Malignancy-Other | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | View |
| SecondaryMalignancy-Other:PERIPHERALPRIMITIVENEUROECTODERMALTUMOR/ EWINGSARCOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | View |
| SecondaryMalignancy-Other:SpindleCellSarcoma-periaortic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | View |
| SecondaryMalignancy-Other:Squamouscellcarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal-Other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Dyspepsia/Heartburn | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Allergy/Immunology-Other | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Allergy/Immunology-Other:Sorethroat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Allergy/Immunology-Other:excessmucus | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Allergy/Immunology-Other:lymphnodeswelling | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (2.0) | View |
| Allergy/Immunology-Other:moresignificanthistaminereaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (2.0) | View |
| Auditory/Hearing-Other | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (2.0) | View |
| Hemoglobin-Hgb | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Leukopenia (total WBC) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Transfusion: pRBCs | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Transfusion; Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Transfusion; pRBC's | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (2.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (2.0) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Sinus Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Fibrinogen | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Partial thromboplastin time (PTT) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Prothrombin time (PT) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Constitutional Symptoms-Other | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Fatigue (lethargy, malaise, asthenia) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Fever-absence of Neutropenia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Rigors, chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Rigors/Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Sweating (Diaphoresis) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Sweating (diaphoresis) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Death not associated with CTCAE term - Disease progression NOS | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | View |
| Bruising (absence of thrombocytopenia grade 3/4) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (2.0) | View |
| Bruising (in absence of grade 3 or 4 thrombocytopenia) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (2.0) | View |
| Dermatology/Skin-Other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Dermatology/Skin-Other:Face&neckpimples | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Dermatology/Skin-Other:SpongioticDermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Dermatology/Skin-Other:pimples | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Dry Skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Rash/Desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Wound-Infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Hot Flashes/Flushes | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (2.0) | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (2.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Diarrhea (without colostomy) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Diarrhea patients without colostomy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Gastrointestinal-Other:erythemaofpharynx | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Taste disturbance (dysgeusia) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Hematuria (in the absence of vaginal bleeding) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Hemorrhage/Bleeding w/gr 3/4 Thrombocytopenia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Petechiae/Purpura(hemorrhage/bleeding skin/mucosa) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Bilirubin | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Hepatic-Other:Hypoproteinemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| SGOT (AST) (serum glutamic oxaloacetic transaminase) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| SGPT (ALT) (serum glutamic pyruvic transaminase) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Alkaline Phosphatase | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Hepatic-Other | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| SGOT(AST) (serum glutamic oxal. Transaminase) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| SGPT(ALT) (seurm glutamic pyruric trans.) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Infection without Neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Infection without neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Lymphatics-Other | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Lymphatics-Other:cervicaladenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Acidosis (metabolic or respiratory) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Alkalosis (metabolic or respiratory) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Amylase | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Bicarbonate | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypercholesterolemia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypermagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hyperuricemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypomagnesmia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Lipase | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Metabolic/Laboratory-Other | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Metabolic/Laboratory-Other:Hyperchloremia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Metabolic/Laboratory-Other:Hypochloremia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Musculoskelatal-Other | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Dizziness/Lightheadedness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Dizziness/lightheadedness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (2.0) | View |
| Mood alteration-anxiety, agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (2.0) | View |
| Neurology-Other:Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (2.0) | View |
| Neuropathy - motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Neuropathy-Sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Dry Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Ocular-Visual Other | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Ocular/Visual-Other:Periorbitalerythemaandswelling | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Ocular/Visual-Other:Visionhaziness | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Tearing (watery eyes) | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Abdominal Pain or Cramping | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Abdominal pain or cramping | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Arthralgia (joint pain) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Bone Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Chest Pain (non-cardiac, non-pleuritic) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Chest pain (non-cardiac and non-pleuritic) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Myalgia (muscle pain) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Neuropathic Pain | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Pain-Other | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Pain-Other:Ankle,backandknee | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Pain-Other:Legpain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Pain-Other:Oralpain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Pain-Other:SORETHROAT | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Pain-Other:bodyaches | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Pain-Other:generalizedaches&pains | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Pain-Other:lefthandpain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Pain-Other:leftshoulder | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Pain-Other:upperrightarm | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Tumor pain (onset or exacerbation of tumor pain due to treatment) | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Pulmonary-Other | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Pulmonary-Other:Reactiveairwaydisease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Pulmonary-Other:SORETHROAT | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Pulmonary-Other:Tachypnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Pulmonary-Other:RespiratoryFailure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Pulmonary-Other:sorethroat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Dysuria (painful urination) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Renal/Genitourinary-Other | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Renal/Genitourinary-Other:BUN | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Urinary Frequency/Urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| SecondaryMalignancy-Other:Highgradesarcoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | View |
| SecondaryMalignancy-Other:MyelodysplasticSyndrome | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | View |
| SecondaryMalignancy-Other:squamouscellcarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | View |