Adverse Events Module

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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 @ 12:55 AM
Ignite Modification Date: 2025-12-25 @ 11:10 PM
NCT ID: NCT02013167
Description: Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Frequency Threshold: 5
Time Frame: From first dose of protocol-specified therapy until 30 days after the last dose, up to the data cut-off date of 04 January 2016; median duration of treatment was 5 days in the SOC group and 70 days in the blinatumomab group.
Study: NCT02013167
Study Brief: Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard of Care Chemotherapy Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh\*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\*/CRi could continue to receive SOC therapy for an additional 12 months. None None 49 109 105 109 View
Blinatumomab Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh\*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period. The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles. None None 165 267 250 267 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Agranulocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Febrile bone marrow aplasia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Histiocytosis haematophagic SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Aplasia SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 18.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gastric haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gastrointestinal inflammation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gastrointestinal necrosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Mouth haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Medical device complication SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Systemic inflammatory response syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Acute hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Acute graft versus host disease in skin SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Anaphylactic shock SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Graft versus host disease SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Graft versus host disease in liver SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Abscess fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Brain abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Bronchopulmonary aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Catheter site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Central nervous system abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Citrobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Citrobacter sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Device related sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Encephalitis enteroviral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Enterococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Enterococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Escherichia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Fungaemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Fungal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Fusarium infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Hepatosplenic candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Infection in an immunocompromised host SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Lower respiratory tract infection fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Mastoiditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Meningitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Mucormycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Muscle abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia respiratory syncytial viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Progressive multifocal leukoencephalopathy SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pseudomonal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pulmonary mycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Respiratory syncytial virus bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Sepsis syndrome SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Streptococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Systemic candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Medication error SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Subdural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
CSF cell count abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Lactic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Tumour lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Osteitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Acute lymphocytic leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Leukaemic infiltration extramedullary SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Leukaemic infiltration pulmonary SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Tumour associated fever SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Generalised tonic-clonic seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Hemianopia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Hemiplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Intention tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Leukoencephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Neurological symptom SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Status epilepticus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Completed suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Calculus ureteric SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Urinary bladder haemorrhage SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Lung infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Respiratory arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Catheter placement SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.1 View
Aortic occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Peripheral artery thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Hypogammaglobulinaemia SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View