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 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
NCT ID:
NCT00253435
Description:
None
Frequency Threshold:
1
Time Frame:
None
Study:
NCT00253435
Study Brief:
N2001-02: I-MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Poor Risk Patients | Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction. | None | None | 12 | 42 | 42 | 42 | View |
| Good Risk Patients | Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction. | None | None | 3 | 8 | 8 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blood/Bone Marrow - Other (DELAYED PLATELET ENGRAFTMENT) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v3.0 | View |
| Blood/Bone Marrow - Other (INFUSION OF BACKUP STEM CELLS) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v3.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Hepatobiliary/Pancreas - Other (HEPATOMEGALY) | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE v3.0 | View |
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils (Blood) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils (Catheter-related) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Bilirubin (hyperbilirubinemia) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Albumin, serum-low (hypoalbuminemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Pain (Head/headache) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v3.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v3.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blood/Bone Marrow - Other (DELAYED ENGRAFTMENT ANC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v3.0 | View |
| Blood/Bone Marrow - Other (INFUSION OF BACKUP SC FOR DELAYED ENGRAFTMENT) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v3.0 | View |
| Ventricular arrhythmia (Ventricular arrhythmia NOS) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v3.0 | View |
| Hearing: patients with/without baseline audiogram and enrolled in a monitoring program | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE v3.0 | View |
| Hearing: patients without baseline audiogram and not enrolled in a monitoring program | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE v3.0 | View |
| Distension/bloating, abdominal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Dry mouth/salivary gland (xerostomia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Hemorrhage, GI (Lower GI NOS) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Hemorrhage, GI (Oral cavity) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Mucositis/stomatitis (clinical exam) (Oral cavity) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Mucositis/stomatitis (clinical exam) (Rectum) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Mucositis/stomatitis (functional/symptomatic) (Large bowel) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Mucositis/stomatitis (functional/symptomatic) (Oral cavity) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Salivary gland changes/saliva | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Typhlitis (cecal inflammation) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Constitutional Symptoms - Other (BRITTLE HAIR) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Pain - Other (CVC SITE) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Pain - Other (GENERAL (NOS)) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Pain - Other (MOUTH PAIN) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Colitis, infectious (e.g., Clostridium difficile) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Blood) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Skin (cellulitis)) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection - Other (ASPERGILLUS OF MOUTH) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils (Blood) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils (Bronchus) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils (Small bowel NOS) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v3.0 | View |
| Rash: dermatitis associated with radiation (Chemoradiation) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v3.0 | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Metabolic/Laboratory - Other (DECREASED TOTAL PROTEIN) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Metabolic/Laboratory - Other (HYPERCHLOREMIA) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Albumin, serum-low (hypoalbuminemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Alkalosis (metabolic or respiratory) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Glucose, serum-high (hyperglycemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Glucose, serum-low (hypoglycemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Sodium, serum-high (hypernatremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Sodium, serum-low (hyponatremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Musculoskeletal/Soft Tissue - Other (OCCASIONAL ACHES AND PAINS) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | View |
| Pain (Neck) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | View |
| Neurology - Other (ACHY FEELING) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v3.0 | View |
| Pain (Head/headache) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v3.0 | View |
| Somnolence/depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v3.0 | View |
| Mood alteration (Agitation) | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v3.0 | View |
| Mood alteration (Anxiety) | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v3.0 | View |
| Hemorrhage, GU (Bladder) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v3.0 | View |
| Hemorrhage, GU (Urinary NOS) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v3.0 | View |
| Pain (Pelvis) | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE v3.0 | View |
| Pain (Penis) | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE v3.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Mucositis/stomatitis (clinical exam) (Pharynx) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Pneumonitis/pulmonary infiltrates | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Pulmonary/Upper Respiratory - Other (CONGESTION) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Dermatology/Skin - Other (DRY LIPS) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Dermatology/Skin - Other (FACIAL ABRAISIONS) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Dermatology/Skin - Other (INGROWN TOENAIL) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Dermatology/Skin - Other (SUN BURN) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Dermatology/Skin - Other (ZOSTER LESION) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Pruritus/itching | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Ulceration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v3.0 | View |
| Hemorrhage/Bleeding - Other (NOSE BLEED) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v3.0 | View |
| Hemorrhage/Bleeding - Other (TONGUE BLEED) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v3.0 | View |
| Febrile neutropenia (fever of unknown origin) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v3.0 | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v3.0 | View |
| Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v3.0 | View |
| Lymphatics - Other (CAPILLARY LEAK) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v3.0 | View |
| Lymphatics - Other (GENERALIZED EDEMA) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v3.0 | View |
| Cardiac Arrhythmia - Other (MURMUR) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v3.0 | View |
| Cardiac Arrhythmia - Other (SINUS TACHYCARDIA) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v3.0 | View |
| Cardiac General - Other (SYSTOLIC MURMUR) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v3.0 | View |
| Supraventricular and nodal arrhythmia (Atrial tachycardia/Paroxysmal Atrial Tachycardia) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v3.0 | View |
| Supraventricular and nodal arrhythmia (Sinus tachycardia) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v3.0 | View |
| Otitis, middle ear (non-infectious) | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE v3.0 | View |
| Pain (Middle ear) | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE v3.0 | View |
| Endocrine - Other (TSH) | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE v3.0 | View |
| Thyroid function, high (hyperthyroidism, thyrotoxicosis) | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE v3.0 | View |
| Ocular/Visual - Other (BILATERAL CONJUNCTIVAL HEMORRHAGE) | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v3.0 | View |
| Pain (Eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v3.0 | View |
| Ascites (non-malignant) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Cheilitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Dental: teeth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Dysphagia (difficulty swallowing) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Gastrointestinal - Other (HICCUPS) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Gastrointestinal - Other (LOOSE TEETH) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Gastrointestinal - Other (REFLUX) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Heartburn/dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Hemorrhage, GI (Stomach) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Hemorrhage, GI (Upper GI NOS) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Mucositis/stomatitis (clinical exam) (Anus) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Mucositis/stomatitis (clinical exam) (Esophagus) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Mucositis/stomatitis (functional/symptomatic) (Small bowel) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Mucositis/stomatitis (functional/symptomatic) (Stomach) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Obstruction, GI (Small bowel NOS) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Pain (Abdomen NOS) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Pain (Esophagus) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Pain (Oral cavity) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Pain (Oral-gums) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Pain (Rectum) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Pain (Stomach) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v3.0 | View |
| Constitutional Symptoms - Other (RHINORRHEA) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Edema:head and neck | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Edema:limb | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Edema:trunk/genital | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Fatigue (asthenia, lethargy, malaise) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Irritability (children <3 years of age) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Pain (Chest/thorax NOS) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Pain (Face) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Pain (Pain NOS) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Pain - Other (BROVIAC SITE) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Pain - Other (MUCOSITIS) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Pain - Other (OROPHANRIX) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Pain - Other (PAROTID GLAND) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Pain - Other (WHOLE BODY) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Rigors/chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v3.0 | View |
| Hepatobiliary/Pancreas - Other (CHOLANGITIS) | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE v3.0 | View |
| Liver dysfunction/failure (clinical) | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE v3.0 | View |
| Pain (Liver) | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE v3.0 | View |
| Portal vein flow | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE v3.0 | View |
| Allergic reaction/hypersensitivity (including drug fever) | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE v3.0 | View |
| Cytokine release syndrome/acute infusion reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE v3.0 | View |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Catheter-related) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Lung (pneumonia)) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Mucosa) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Sinus) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection - Other (L-PRESEPTAL CELLULITIS) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection - Other (ORAL CANDIDA) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection - Other (PERIRECTAL CELLULITIS) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection - Other (URINE + FOR CYTOMEGALOVIRUS) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection - Other (VARICELLA) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils (Catheter-related) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils (Colon) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils (Lung (pneumonia)) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils (Oral cavity-gums (gingivitis)) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils (Sinus) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils (Upper airway NOS) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection with unknown ANC (Catheter-related) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Infection with unknown ANC (Skin (cellulitis)) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| Opportunistic infection associated with >=Grade 2 Lymphopenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v3.0 | View |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Bilirubin (hyperbilirubinemia) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Cholesterol, serum-high (hypercholesteremia) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Fibrinogen | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| GGT (gamma-Glutamyl transpeptidase) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| INR (International Normalized Ratio of prothrombin time) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Metabolic/Laboratory - Other (CHLORIDE) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Metabolic/Laboratory - Other (HYPERCHLORIDEMIA) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Metabolic/Laboratory - Other (HYPERPHOSPHATEMIA) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Metabolic/Laboratory - Other (INCREASED CHLORIDE) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Metabolic/Laboratory - Other (INCREASED FIBRINOGEN) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Metabolic/Laboratory - Other (PRE-ALBUMIN) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| PTT (Partial Thromboplastin Time) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v3.0 | View |
| Acidosis (metabolic or respiratory) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Bicarbonate, serum-low | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Calcium, serum-high (hypercalcemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Calcium, serum-low (hypocalcemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Magnesium, serum-high (hypermagnesemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Magnesium, serum-low (hypomagnesemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Phosphate, serum-low (hypophosphatemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Potassium, serum-high (hyperkalemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Potassium, serum-low (hypokalemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Triglyceride, serum-high (hypertriglyceridemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Uric acid, serum-high (hyperuricemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v3.0 | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) (Extremity-lower) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) (Extremity-upper) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | View |
| Musculoskeletal/Soft Tissue - Other (NOT SPECIFIED) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | View |
| Pain (Back) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | View |
| Pain (Bone) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | View |
| Pain (Chest wall) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | View |
| Pain (Extremity-limb) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | View |
| Pain (Joint) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | View |
| Neurology - Other (DYSTONIC REACTION) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v3.0 | View |
| Neurology - Other (GENERALIZED TENDERNESS) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v3.0 | View |
| Neuropathy: cranial (CN VII Motor-face; Sensory-taste) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v3.0 | View |
| Neuropathy: motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v3.0 | View |
| Neuropathy: sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v3.0 | View |
| Syncope (fainting) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v3.0 | View |
| Taste alteration (dysgeusia) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v3.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v3.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v3.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v3.0 | View |
| Mood alteration (Depression) | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v3.0 | View |
| Psychosis (hallucinations/delusions) | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v3.0 | View |
| Bladder spasms | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v3.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v3.0 | View |
| Hemoglobinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v3.0 | View |
| Pain (Bladder) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v3.0 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v3.0 | View |
| Renal/Genitourinary - Other (DECREASED URINE OUTPUT) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v3.0 | View |
| Renal/Genitourinary - Other (FLUID RETENTION) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v3.0 | View |
| Urinary retention (including neurogenic bladder) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v3.0 | View |
| Pain (Scrotum) | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE v3.0 | View |
| Vaginal mucositis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE v3.0 | View |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Bronchospasm, wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Hemorrhage, pulmonary/upper respiratory (Nose) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Hemorrhage, pulmonary/upper respiratory (Respiratory tract NOS) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Mucositis/stomatitis (clinical exam) (Larynx) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Mucositis/stomatitis (functional/symptomatic) (Pharynx) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Nasal cavity/paranasal sinus reactions | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Pain (Larynx) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Pain (Throat/pharynx/larynx) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Pleural effusion (non-malignant) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Pulmonary/Upper Respiratory - Other (HYPERCARBIA) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Pulmonary/Upper Respiratory - Other (RHINORRHEA) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Pulmonary/Upper Respiratory - Other (RUNNY NOSE) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Pulmonary/Upper Respiratory - Other (TACHYPNEIC) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | View |
| Dermatology/Skin - Other (LACERATION) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Dermatology/Skin - Other (PEELING SKIN) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Dermatology/Skin - Other (PERIORBITAL ECCHYMOSES) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Dermatology/Skin - Other (PSEUDOMEMBRANOUS CHANGES) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Dermatology/Skin - Other (SORE/SCAB) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Hair loss/alopecia (scalp or body) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Hyperpigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Hypopigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Rash: hand-foot skin reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Skin breakdown/decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Sweating (diaphoresis) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v3.0 | View |
| Hematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v3.0 | View |
| Hemorrhage/Bleeding - Other (EPISTAXIS) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v3.0 | View |
| Hemorrhage/Bleeding - Other (EYE) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v3.0 | View |
| Hemorrhage/Bleeding - Other (HEMATURIA) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v3.0 | View |
| Hemorrhage/Bleeding - Other (HEMOPTYSIS) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v3.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v3.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v3.0 | View |