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 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
NCT ID:
NCT00112827
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 occurred over a period of 14 years and 3 months.
Study:
NCT00112827
Study Brief:
Melphalan and Radiation Therapy Followed By Lenalidomide in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant for Stage I, Stage II, or Stage III Multiple Myeloma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy) | See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally | 3 | None | 0 | 4 | 4 | 4 | View |
| Phase 1 Cohort 1 (Total TMI Dose: 1000 cGy) | See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally | 2 | None | 0 | 3 | 3 | 3 | View |
| Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy) | See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally | 4 | None | 0 | 4 | 3 | 4 | View |
| Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy) | See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally | 20 | None | 6 | 36 | 33 | 36 | View |
| Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy) | See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally | 4 | None | 3 | 7 | 7 | 7 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Colitis, infectious (e.g., Clostridium difficile) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra9.0 | View |
| Hypophosphatemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra10.0 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Pain of skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Rash desquamating | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra10.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Supraventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| Wolff-Parkinson-White syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| External ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | meddra10.0 | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | meddra10.0 | View |
| Adrenal insufficiency | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | meddra10.0 | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | meddra9.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Anal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Anal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Ear, nose and throat examination abnormal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Esophageal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Esophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Gastric mucositis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Gastrointestinal disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Gingival pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Hemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Mucositis oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Oesophagoscopy abnormal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Oral pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Rectal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Retroperitoneal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Stomach pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Disease progression | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Edema limbs | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Facial pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| General symptom | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Ill-defined disorder | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Localized edema | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Visceral edema | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Immune system disorder | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | meddra9.0 | View |
| Abdominal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra9.0 | View |
| Anal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | 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 |
| Conjunctivitis infective | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Gingival infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra9.0 | View |
| Infectious colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra9.0 | View |
| Lip infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Opportunistic infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Peripheral nerve infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra9.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra9.0 | View |
| Upper respiratory infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra9.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Wound dehiscence | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra10.0 | View |
| Activated partial thromboplastin time prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Blood gonadotrophin abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Electrocardiogram QTc interval prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Hypercholesterolemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| INR increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Laboratory test abnormal | 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 | meddra9.0 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Serum cholesterol increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Weight gain | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Weight loss | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Alkalosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Blood bicarbonate decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | 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 |
| Hyperkalemia | 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 |
| Obesity | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | 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 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 potassium increased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Serum sodium decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Serum sodium increased | 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 | meddra9.0 | View |
| Chest wall pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra10.0 | View |
| Joint effusion | 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 | meddra9.0 | View |
| Muscle weakness lower limb | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra9.0 | View |
| Musculoskeletal disorder | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra10.0 | View |
| Myositis | 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 | meddra9.0 | View |
| Tumor pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra9.0 | View |
| Depressed level of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Memory impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Neurological disorder NOS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Oculomotor nerve disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Peripheral motor neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Sinus pain | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Speech disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Syncope | 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 |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra10.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra10.0 | View |
| Bladder pain | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary 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 |
| Protein urine positive | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra10.0 | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra10.0 | View |
| Urethral pain | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra10.0 | View |
| Urinary frequency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra10.0 | View |
| Urogenital disorder | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra10.0 | View |
| Gynecomastia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | meddra10.0 | View |
| Pelvic pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | meddra10.0 | View |
| Perineal pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | meddra10.0 | View |
| Vaginal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | meddra9.0 | View |
| Vaginal inflammation | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | meddra10.0 | View |
| Allergic rhinitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | View |
| Apnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | View |
| Atelectasis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | View |
| Bronchospasm | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | View |
| Hemorrhage nasal | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | View |
| Hiccough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | View |
| Laryngeal mucositis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Laryngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | View |
| Respiratory disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | View |
| Voice alteration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Decubitus ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Erythema multiforme | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Nail disorder | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Pain of skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Petechiae | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Rash acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Rash desquamating | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Skin disorder | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Skin hyperpigmentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Skin hypopigmentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Sweating | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra9.0 | View |
| Hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra10.0 | View |
| Hot flashes | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra9.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra9.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra10.0 | View |
| Phlebitis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra10.0 | View |
| Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra10.0 | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Hemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Lymphatic disorder | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra10.0 | View |
| Arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Serum glucose decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra10.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra9.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra9.0 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra10.0 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | View |
| Pharyngolaryngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| Cardiac disorder | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| Conduction disorder | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| Left ventricular failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| Mobitz type I | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra10.0 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra10.0 | View |
| Pericardial effusion | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| Pericarditis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| Sinus bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra10.0 | View |
| Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra10.0 | View |
| Dry eye syndrome | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | meddra9.0 | View |
| Flashing vision | 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 |
| Esophageal mucositis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |