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 @ 3:45 PM
Ignite Modification Date:
2025-12-25 @ 1:52 PM
NCT ID:
NCT00004092
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 were collected over a period of 8 years.
Study:
NCT00004092
Study Brief:
Combination Chemotherapy in Treating Patients With High-Risk 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 |
|---|---|---|---|---|---|---|---|---|
| Arm II (STAMP V) | Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I. filgrastim: Given IV or subcutaneously carboplatin: Given IV cyclophosphamide: Given IV thiotepa: Given IV peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells | None | None | 0 | 51 | 50 | 51 | View |
| Arm I (ACT) | Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover. filgrastim: Given IV or subcutaneously cyclophosphamide: Given IV doxorubicin hydrochloride: Given IV paclitaxel: Given IV peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells | None | None | 0 | 21 | 21 | 21 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | 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 |
| Weight gain | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Weight loss | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Hemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Lymphangiopathy NOS | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Lymphatic disorder | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| Arrhythmia supraventricular | 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 |
| Myocardial ischemia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| Ventricular arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| Ear disorder | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | meddra9.0 | View |
| Ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | meddra9.0 | View |
| Hearing loss | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | meddra9.0 | View |
| Conjunctival disorder | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | meddra9.0 | View |
| Diplopia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | meddra9.0 | View |
| Dry eye syndrome | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | meddra9.0 | View |
| Eye disorder | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | meddra9.0 | View |
| Vision blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | meddra9.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Diarrhea (Somlo COH) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Somlo | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Dysphagia, esophagitis, odynophagia (Somlo COH) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Somlo | View |
| Esophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Gastrointestinal disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Incontinence NOS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Melaena | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Nausea (Somlo COH) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Somlo | View |
| Proctitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Rectal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Stomatitis/phayngitis (Somlo COH) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Somlo | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Vomiting (Somlo COH) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Somlo | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Edema | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Oedema NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | meddra9.0 | View |
| Immune system disorder | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | meddra9.0 | View |
| Catheter related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra9.0 | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra9.0 | View |
| Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra9.0 | View |
| Infection NOS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra9.0 | View |
| Infection, Bacterial (COH) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | COH | View |
| Infection, Fungal (COH) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | COH | View |
| Infection, Viral (COH) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | COH | View |
| Wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra9.0 | View |
| Bruising | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra9.0 | View |
| Dermatitis radiation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra9.0 | View |
| Wound dehiscence | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra9.0 | View |
| ADH abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Activated partial thromboplastin time prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Alk Phos (Somlo COH) | NON_SYSTEMATIC_ASSESSMENT | Investigations | Somlo | View |
| Alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Electrocardiogram QTc interval prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Hyperbilirubinemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Hypercholesterolemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| INR increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Leukocyte 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 |
| Neutrophils (ANC) (Somlo COH) | NON_SYSTEMATIC_ASSESSMENT | Investigations | Somlo | View |
| Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol. | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Platelets (Somlo COH) | NON_SYSTEMATIC_ASSESSMENT | Investigations | Somlo | View |
| SGOT (Somlo COH) | NON_SYSTEMATIC_ASSESSMENT | Investigations | Somlo | View |
| SGPT (Somlo COH) | NON_SYSTEMATIC_ASSESSMENT | Investigations | Somlo | View |
| Serum cholesterol increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Acidosis | 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 |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | 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 |
| Hypermagnesemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Hypernatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Hypertriglyceridemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Hyperuricemia | 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 magnesium decreased | 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 |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra9.0 | View |
| Joint pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra9.0 | View |
| Muscle weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra9.0 | View |
| Musculoskeletal disorder | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra9.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra9.0 | View |
| Treatment related secondary malignancy | 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 | meddra9.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Extrapyramidal disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Neurological disorder NOS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Olfactory nerve disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Peripheral motor neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Pyramidal tract syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Taste alteration | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra9.0 | View |
| Confusion | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra9.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra9.0 | View |
| Euphoria | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra9.0 | View |
| Hallucination NOS | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra9.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra9.0 | View |
| Psychosis | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra9.0 | View |
| Bladder pain | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra9.0 | View |
| Bladder spasm | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra9.0 | View |
| Blood urine present | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra9.0 | View |
| Urinary frequency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra9.0 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra9.0 | View |
| Urogenital disorder | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra9.0 | View |
| Irregular menstruation | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | meddra9.0 | View |
| Vaginal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | meddra9.0 | View |
| Vaginal inflammation | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | meddra9.0 | View |
| Allergic rhinitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | 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 |
| Haemoptysis | 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 | meddra9.0 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | 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 |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Erythema multiforme | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Hand-and-foot syndrome | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Nail disorder | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Petechiae | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Rash desquamating | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Skin discolouration | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Skin disorder | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Sweating | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Urticaria | 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 | meddra9.0 | 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 | meddra9.0 | View |
| Leukocytes (total WBC) for BMT studies, if specified in the protocol. | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Platelets for BMT studies, if specified in the protocol. | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Rash/dermatitis associated with high-dose chemotherapy or BMT studies. | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Rash/desquamation associated with graft versus host disease (GVHD) for BMT studies | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol. | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Transfusion: Platelets for BMT studies, if specified in the protocol. | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Transfusion: pRBCs for BMT studies, if specified in the protocol. | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Disseminated intravascular coagulation | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Haemorrhage NOS | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Diarrhea associated with graft versus host disease (GVHD) for BMT studies | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Haematemesis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |