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 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
NCT ID:
NCT00182793
Description:
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Frequency Threshold:
0
Time Frame:
Adverse events took place over a period of 4 years, 3 months.
Study:
NCT00182793
Study Brief:
Combination Chemotherapy With or Without Trastuzumab Followed By an Autologous Stem Cell Transplant and Radiation Therapy in Treating Patients With Stage III or Stage IV 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 |
|---|---|---|---|---|---|---|---|---|
| All Patients | Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites. | None | None | 24 | 32 | 30 | 32 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Disseminated intravascular coagulation | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra10.0 | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra10.0 | View |
| Adrenal insufficiency | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | meddra10.0 | View |
| Endocrine disorder | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | meddra10.0 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Multi-organ failure | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Hepatic failure | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | meddra10.0 | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Prolonged intubation after pulmonary resection (>24 hrs after surgery) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra10.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Serum glucose decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra10.0 | View |
| Muscle weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra10.0 | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra10.0 | View |
| Adult respiratory distress syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra10.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Proctitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Rectal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Rectal mucositis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Rectal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Upper gastrointestinal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Edema limbs | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| General symptom | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Localized edema | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Catheter related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra9.0 | View |
| Colitis, infectious (e.g., Clostridium difficile) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Gingival infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Opportunistic infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Upper aerodigestive tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Upper respiratory infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Intraoperative gastrointestinal injury - Teeth | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra10.0 | View |
| Activated partial thromboplastin time prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Coagulopathy | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Hypercholesterolemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| INR increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Leukocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Serum cholesterol increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Weight gain | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Weight loss | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Blood bicarbonate decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Blood glucose increased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Blood uric acid increased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Hypercalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Hypertriglyceridemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Hypocalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Hypoglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Hypomagnesemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Hypophosphatemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Serum albumin decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Serum calcium decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Serum calcium increased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Serum glucose decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Serum magnesium decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Serum magnesium increased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Serum phosphate decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Serum potassium decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Serum sodium decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Serum triglycerides increased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra10.0 | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra10.0 | View |
| Joint pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra10.0 | View |
| Muscle weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra10.0 | View |
| Muscle weakness lower limb | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra10.0 | View |
| Musculoskeletal disorder | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra9.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra10.0 | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra10.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra10.0 | View |
| Depressed level of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Neurological disorder NOS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Peripheral motor neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Sinus pain | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Taste alteration | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Agitation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra10.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra10.0 | View |
| Confusion | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra10.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra10.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra10.0 | View |
| Personality change | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra9.0 | View |
| Psychosis | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra10.0 | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra10.0 | View |
| Hemorrhage urinary tract | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra10.0 | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra10.0 | View |
| Urogenital disorder | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra10.0 | View |
| Irregular menstruation | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | meddra10.0 | View |
| Pelvic pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | meddra9.0 | View |
| Vaginal dryness | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | meddra10.0 | View |
| Vaginal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | meddra10.0 | View |
| Vaginal pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | meddra10.0 | View |
| Allergic rhinitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Bronchospasm | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Hemorrhage nasal | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Hiccough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Pharyngolaryngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Respiratory disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Voice alteration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Decubitus ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Hand-and-foot syndrome | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Petechiae | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Photosensitivity | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Rash acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Rash desquamating | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Skin disorder | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Skin hyperpigmentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Skin ulceration | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Sweating | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Telangiectasia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra10.0 | View |
| Hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra10.0 | View |
| Hot flashes | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra10.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra10.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra10.0 | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra10.0 | View |
| Hemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra10.0 | View |
| Lymphatic disorder | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra10.0 | View |
| Arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| Cardiac disorder | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| Left ventricular failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra10.0 | View |
| Premature ventricular contractions | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra10.0 | View |
| Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra10.0 | View |
| Supraventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra10.0 | View |
| Ventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| External ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | meddra10.0 | View |
| Endocrine disorder | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | meddra10.0 | View |
| Dry eye syndrome | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | meddra10.0 | View |
| Vision blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | meddra10.0 | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Anal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Ear, nose and throat examination abnormal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Gastrointestinal disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Gingival pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Hemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Intra-abdominal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Lower gastrointestinal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Mucositis oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Oral hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Oral pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |