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 @ 10:12 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
NCT ID:
NCT00004635
Description:
None
Frequency Threshold:
0
Time Frame:
Date treatment consent signed to date off study, approximately 5 years.
Study:
NCT00004635
Study Brief:
Thalidomide for the Treatment of Hormone-Dependent Prostate 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 |
|---|---|---|---|---|---|---|---|---|
| Thalidomide | None | 0 | None | 117 | 138 | 67 | 138 | View |
| Placebo | None | 0 | None | 98 | 124 | 63 | 124 | View |
| Leuprolide | None | 0 | None | 124 | 159 | 66 | 159 | View |
| Goserelin (Zoladex) | None | 0 | None | 13 | 159 | 10 | 159 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Allergic reaction/hypersensitivity (including drug fever) | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCv2.0 | View |
| Abdominal pain or cramping | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCv2.0 | View |
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCv2.0 | View |
| Chest pain (non-cardiac and non-pleuritis) | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Arrhythmia-other | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Arthralgia (joint pain) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Ataxia (incoordination) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Bilirubin | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Brusing (in absence of grade 3 or 4 thrombocytopenia) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| CNS cerebrovascular ischemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| CPK (creatine phosphokinase) | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Circulatory or cardiac-Other | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Cognitive disturbance/learning problems | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCv2.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Constitutional symptoms-Other | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Derma/Skin-Other: Lower lip lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Diarrhea (without colostomy) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Dizziness/lightheadedness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv2.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Dyspepsia/heartburn | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Dysphagia, esophagitis, odynophagia (painful swallowing) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Dysuria (painful urination) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv2.0 | View |
| Edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Erectile impotence | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCv2.0 | View |
| Extrapyramidal/involuntary movement/restlessness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Fatigue (lethargy, malaise, asthenia) | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Fever (in absence of neutropenia, where neutropenia is defined as AGC<1.0x109/L) | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv2.0 | View |
| GI-Other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Gynecomastia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCv2.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Hearing-Other | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCv2.0 | View |
| Hematologic-Other | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Hematuria (in the absence of vaginal bleeding) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv2.0 | View |
| Hemoglobin (Hgb) | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis, other | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Hiccoughs (hiccups, singultus) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Hot flashes/flashes | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv2.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypermagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv2.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypomagnesmia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv2.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCv2.0 | View |
| Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv2.0 | View |
| Infection without neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Infection, Other | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Inner ear/hearing | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCv2.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCv2.0 | View |
| Joint, muscle, or bone (osseous)-Other | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Libido | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCv2.0 | View |
| Lymphatics | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Memory loss | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Mood alteration-anxiety agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCv2.0 | View |
| Mood alteration-depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCv2.0 | View |
| Mouth dryness | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Muscle cramps (thigh) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Muscle weakness (not due to neuropathy) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Myalgia (muscle ache) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Nail changes | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Neurologic-Other | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Neuropathy cranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Neuropathy motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Neuropathy-sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Ocular-Other | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv2.0 | View |
| Pain-Other | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Palpitation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Photosensitivity | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Protrombin Time/INR-International Normalized Ratio of protrombin time | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Pulmonary-Other | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Rectal bleeding/hematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Rectal or perirectal pain (proctalgia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| SGOT (AST) | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| SGPT (ALT) | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Salivary gland changes | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Secondary Malignancy-Other | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCv2.0 | View |
| Sense of smell | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Skin-Other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Supraventricular arrhythmias (SVT/atrial fibrillation/flutter) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Taste disturbance (dysgeusia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Tearing (watery eyes) | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv2.0 | View |
| Thrombosis/embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv2.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Urinary frequency/urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv2.0 | View |
| Urticaria (hives, welts, wheals) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Vision-blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv2.0 | View |
| Vision-double vision (diplopia) | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv2.0 | View |
| Vision-flashing lights/floaters | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv2.0 | View |
| Vision-night blindness (nyctalopia) | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv2.0 | View |
| Voice changes/stridor/larynx (e.g., hoarsneness, loss of voice, laryngitis) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Wound-infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Pneumonitis/pulmonary infiltrates | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Renal/GU-Other | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv2.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Sweating (diaphoresis) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Cardiac-ischemia/infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Cardiac-left ventricular function | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Endocrine-Other | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCv2.0 | View |
| Impotency | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCv2.0 | View |
| LDH | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Metabolic-Other | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralgia, or | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Pleural effusion (non-malignant) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Rigors/chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Hypercholesterolemia | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Vision-photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv2.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Seizure(s) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Vasovagal episode | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCv2.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Proctitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Rectal bleeding/hematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| SGOT (AST) | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Infection with unknown ANC | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCv2.0 | View |
| Mood alteration-depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCv2.0 | View |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCv2.0 | View |
| Abdominal pain or cramping | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCv2.0 | View |
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Cardiac left ventricular function | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Cardiac-ischemia/infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv2.0 | View |
| Circulatory or cardiac-Other | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Endocrine-Other | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCv2.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv2.0 | View |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Trauma R. big toe | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCv2.0 | View |
| Ureteral obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv2.0 | View |
| Urinary frequency/urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv2.0 | View |
| Voice changes/stridor/larynx (e.g., hoarsneness, loss of voice, laryngitis) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCv2.0 | View |
| Arthralgia (joint pain) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| CPK (creatine phosphokinase) | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Diarrhea (without colostomy) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Erectile impotence | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCv2.0 | View |
| Hematologic-Other | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Hepatic-Other | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCv2.0 | View |
| Hot flashes/flashes | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv2.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv2.0 | View |
| Supraventricular arrhythmias (SVT/atrial fibrillation/flutter) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Taste disturbance (dysgeusia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Sweating (diaphoresis) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Muscle weakness (not due to neuropathy) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| GI-Other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Allergy-Other | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCv2.0 | View |
| Hemoglobinuria | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv2.0 | View |
| Vasovagal episode | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Vision-blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv2.0 | View |
| Pyramidal tract dysfunction (e.g., increased tone, hyperreflexia, positive Babinski, decreased fine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Rigors/chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Extrapyramidal/involuntary movement/restlessness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Coag-Other | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Dizziness/lightheadedness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Dyspepsia/heartburn | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Fatigue (lethargy, malaise, asthenia) | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Hearing-Other | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCv2.0 | View |
| Hematuria (in the absence of vaginal bleeding) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv2.0 | View |
| Hemoglobin (Hgb) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypermagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hyperuricemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypomagnesmia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv2.0 | View |
| Infection without neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Infection, Other | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Inner ear/hearing | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCv2.0 | View |
| Joint, muscle, or bone (osseous)-Other | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Middle ear/hearing | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCv2.0 | View |
| Mood alteration-anxiety agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCv2.0 | View |
| Mouth dryness | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Myalgia (muscle ache) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Myositis (inflammation/damage of muscle) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralgia, or | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Neuropathy-sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Ocular-Other | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCv2.0 | View |
| Pain-Other | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Photosensitivity | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Pneumonitis/pulmonary infiltrates | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Pulmonary-Other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Renal/GU-Other | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv2.0 | View |
| SGPT (ALT) | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Secondary Malignancy-Other | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCv2.0 | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Skin-Other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Arrhythmia-Other | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Ataxia (incoordination) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Bilirubin | SYSTEMATIC_ASSESSMENT | Investigations | CTCv2.0 | View |
| Chest pain (non-cardiac and non-pleuritic) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Constitutional symptoms-Other | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Fever (in absence of neutropenia where neutropenia is defined as AGC<1.0x109)L | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Dysuria (painful urination) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv2.0 | View |