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:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
NCT ID:
NCT00232505
Description:
Categorical "Other, Specify" events listed below include verbatim from data collection source in footnotes
Frequency Threshold:
1
Time Frame:
Adverse events were collected up to 30 days after treatment
Study:
NCT00232505
Study Brief:
Cetuximab + / - Carboplatin for Estrogen Receptor-Negative, Progesterone Receptor-Negative Metastatic Breast 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 |
|---|---|---|---|---|---|---|---|---|
| Cetuximab | Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II. cetuximab: Given IV | None | None | 3 | 31 | 27 | 31 | View |
| Cetuximab and Carboplatin After Cetuximab Alone | Patients from Arm 1 who progressed on cetuximab alone who went on to receive cetuximab + carboplatin | None | None | 8 | 25 | 24 | 25 | View |
| Cetuximab and Carboplatin | Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. cetuximab: Given IV carboplatin: Given IV | None | None | 20 | 71 | 68 | 71 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Edema: limb | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Allergic reaction/hypersensitivity (including drug fever) | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (3.0) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Confusion | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dyspnea (shortness of breath) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Extremity-lower (gait/walking) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fatigue (asthenia, lethargy, malaise) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Gastrointestinal - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Gastrointestinal - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, CNS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Hemorrhage, GI - Esophagus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Magnesium, serum-low (hypomagnesemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Right-sided | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Neutrophils/granulocytes (ANC/AGC) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Pain - Abdomen NOS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Pain - Bone | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Chest wall | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Chest/thorax NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Extremity-limb | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Middle ear | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (3.0) | View |
| Pain - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Tumor pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | View |
| Pleural effusion (non-malignant) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Pneumonitis/pulmonary infiltrates | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Potassium, serum-low (hypokalemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Pulmonary/Upper Respiratory - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Secondary Malignancy - possibly related to cancer treatment (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Somnolence/depressed level of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Supraventricular and nodal arrhythmia - Atrial tachycardia/Paroxysmal Atrial Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Supraventricular and nodal arrhythmia - Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Thrombosis/embolism (vascular access-related) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (3.0) | View |
| Thrombosis/thrombus/embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Ulceration | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Cardiac General - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Cardiac General - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Left ventricular diastolic dysfunction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Albumin, serum-low (hypoalbuminemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Alkaline phosphatase | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Allergic reaction/hypersensitivity (including drug fever) | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (3.0) | View |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (3.0) | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Arthritis (non-septic) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Calcium, serum-low (hypocalcemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Cardiac General - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Constitutional Symptoms - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Creatinine | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Dry eye syndrome | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Dry mouth/salivary gland (xerostomia) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Dysphagia (difficulty swallowing) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dyspnea (shortness of breath) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Edema: limb | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Extremity-lower (gait/walking) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fatigue (asthenia, lethargy, malaise) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (3.0) | View |
| Gastritis (including bile reflux gastritis) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Gastrointestinal - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Glucose, serum-high (hyperglycemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hair loss/alopecia (scalp or body) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Heartburn/dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemoglobin | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hemorrhage, pulmonary/upper respiratory - Nose | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Hot flashes/flushes | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Eye NOS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Joint | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Ungual (nails) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Vagina | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with unknown ANC - Sinus | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with unknown ANC - Skin (cellulitis) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Joint-function | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Leukocytes (total WBC) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Magnesium, serum-low (hypomagnesemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Memory impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Metabolic/Laboratory - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Mood alteration - Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Mood alteration - Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Mucositis/stomatitis (clinical exam) - Oral cavity | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Mucositis/stomatitis (functional/symptomatic) - Oral cavity | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Nail changes | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Neurology - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy: motor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy: sensory | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neutrophils/granulocytes (ANC/AGC) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Ocular/Visual - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Pain - Abdomen NOS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Pain - Bone | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Breast | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Buttock | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Cardiac/heart | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Pain - Chest wall | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Pain - Chest/thorax NOS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Pain - Extremity-limb | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Head/headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Pain - Joint | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Liver | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (3.0) | View |
| Pain - Lymph node | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Pain - Muscle | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Neck | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Pain NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Tumor pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | View |
| Platelets | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Potassium, serum-low (hypokalemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Pruritus/itching | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Pulmonary/Upper Respiratory - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Rash/desquamation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash: acne/acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash: dermatitis associated with radiation - Chemoradiation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash: hand-foot skin reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rigors/chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Sweating (diaphoresis) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Taste alteration (dysgeusia) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Vaginal dryness | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (3.0) | View |
| Vision-blurred vision | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Vision-flashing lights/floaters | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Watery eye (epiphora, tearing) | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Weight gain | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Breast function/lactation | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (3.0) | View |
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (3.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Dermatology/Skin - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Musculoskeletal/Soft Tissue - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Back | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Sodium, serum-low (hyponatremia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |