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 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
NCT ID:
NCT00096018
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00096018
Study Brief:
Fludarabine and Thalidomide in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
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 I - Dose Escalation | Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days) | None | None | 6 | 13 | 9 | 13 | View |
| Phase II | Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days) | None | None | 15 | 25 | 25 | 25 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia - Grade 1 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Anaemia - Grade 3 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Anaemia - Grade 4 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Febrile neutropenia - Grade 2 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Febrile neutropenia - Grade 3 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Febrile neutropenia - Grade 4 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Leukopenia - Grade 3 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Neutropenia - Grade 3 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Neutropenia - Grade 4 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Thrombocytopenia - Grade 4 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Angina pectoris - Grade 4 | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.1 | View |
| Death - Grade 5 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Fatigue - Grade 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Fatigue - Grade 3 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Oedema peripheral - Grade 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Pyrexia - Grade 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Hypersensitivity - Grade 3 | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 9.1 | View |
| Pneumonia - Grade 3 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Upper respiratory tract infection - Grade 2 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Upper respiratory tract infection - Grade 3 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Femur fracture - Grade 3 | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Liver function test abnormal - Grade 4 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Decreased appetite - Grade 1 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Failure to thrive - Grade 3 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Tumour lysis syndrome - Grade 3 | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | View |
| Dysgeusia - Grade 1 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Dyspnoea - Grade 3 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Pleural effusion - Grade 3 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Pulmonary embolism - Grade 3 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Rash - Grade 3 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Rash erythematous - Grade 4 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Rash generalised - Grade 2 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Coronary artery bypass - Grade 4 | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Deep vein thrombosis - Grade 3 | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 9.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal tenderness - Grade 1 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Constipation - Grade 1 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Constipation - Grade 2 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Diarrhoea - Grade 1 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Diarrhoea - Grade 3 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Dry mouth - Grade 1 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Dysphagia - Grade 1 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Flatulence - Grade 1 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Hypoaesthesia oral - Grade 1 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Nausea - Grade 1 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Nausea - Grade 2 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Paraesthesia oral - Grade 1 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Vomiting - Grade 1 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Vomiting - Grade 2 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Asthenia - Grade 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Asthenia - Grade 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Asthenia - Grade 3 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Chest pain - Grade 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Chest pain - Grade 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Chills - Grade 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Face oedema - Grade 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Fatigue - Grade 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Fatigue - Grade 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Fatigue - Grade 3 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Gait disturbance - Grade 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Generalised oedema - Grade 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Influenza like illness - Grade 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Non-cardiac chest pain - Grade 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Oedema - Grade 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Oedema - Grade 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Oedema peripheral - Grade 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Oedema peripheral - Grade 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Pain - Grade 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Pain - Grade 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Pain - Grade 3 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Pyrexia - Grade 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Temperature intolerance - Grade 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Tenderness - Grade 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Hyperbilirubinaemia - Grade 1 | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 9.1 | View |
| Hyperbilirubinaemia - Grade 2 | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 9.1 | View |
| Hypersensitivity - Grade 2 | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 9.1 | View |
| Candidiasis - Grade 1 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Ear infection - Grade 1 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Fungal infection - Grade 1 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Herpes simplex - Grade 1 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Influenza - Grade 1 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Nasopharyngitis - Grade 1 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Nasopharyngitis - Grade 2 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Oral candidiasis - Grade 1 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Pneumonia - Grade 2 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Sinusitis - Grade 1 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Upper respiratory tract infection - Grade 1 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Upper respiratory tract infection - Grade 2 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Sunburn - Grade 1 | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Thermal burn - Grade 1 | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Activated partial thromboplastin time prolonged - Grade 1 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Activated partial thromboplastin time prolonged - Grade 2 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Alanine aminotransferase increased - Grade 1 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Aspartate aminotransferase increased - Grade 1 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Blood albumin decreased - Grade 1 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Blood bicarbonate decreased - Grade 1 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Blood chloride increased - Grade 1 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Blood creatine increased - Grade 1 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Blood creatinine increased - Grade 1 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Blood creatinine increased - Grade 2 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Blood creatinine increased - Grade 3 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Blood phosphorus - Grade 1 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Blood potassium increased - Grade 1 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Blood urea increased - Grade 1 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Blood uric acid increased - Grade 1 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Haemoglobin decreased - Grade 2 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Haemoglobin decreased - Grade 3 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Hepatic enzyme increased - Grade 1 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Hepatic enzyme increased - Grade 2 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Liver function test abnormal - Grade 2 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Neutrophil count decreased - Grade 2 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Neutrophil count decreased - Grade 4 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Platelet count decreased - Grade 2 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Platelet count decreased - Grade 3 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Protein total decreased - Grade 1 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Protein total decreased - Grade 2 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Prothrombin level abnormal - Grade 1 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Weight decreased - Grade 1 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Weight decreased - Grade 2 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Weight increased - Grade 1 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| White blood cell count decreased - Grade 2 | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Anorexia - Grade 1 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Decreased appetite - Grade 1 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Decreased appetite - Grade 2 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Dehydration - Grade 1 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Fluid retention - Grade 1 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hyperglycaemia - Grade 1 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hyperglycaemia - Grade 3 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hyperkalaemia - Grade 1 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hyperkalaemia - Grade 2 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hypermagnesaemia - Grade 1 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hyperphosphataemia - Grade 1 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hyperphosphataemia - Grade 2 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hyperuricaemia - Grade 1 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hypoalbuminaemia - Grade 1 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hypoalbuminaemia - Grade 2 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hypocalcaemia - Grade 1 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hypocalcaemia - Grade 2 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hypocalcaemia - Grade 3 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hypoglycaemia - Grade 1 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hypokalaemia - Grade 1 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hypokalaemia - Grade 2 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hyponatraemia - Grade 1 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hyponatraemia - Grade 3 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hypoproteinaemia - Grade 1 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Arthralgia - Grade 1 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Arthralgia - Grade 2 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Back pain - Grade 1 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Back pain - Grade 2 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Bone pain - Grade 1 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Flank pain - Grade 1 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Flank pain - Grade 2 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Muscle spasms - Grade 1 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Musculoskeletal discomfort - Grade 1 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Pain in extremity - Grade 1 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Pain in jaw - Grade 1 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Tumour flare - Grade 1 | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | View |
| Tumour flare - Grade 2 | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | View |
| Amnesia - Grade 1 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Convulsion - Grade 2 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Disturbance in attention - Grade 1 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Dizziness - Grade 1 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Dizziness - Grade 2 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Dizziness - Grade 3 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Dizziness postural - Grade 1 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Headache - Grade 1 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Headache - Grade 2 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Hypoaesthesia - Grade 1 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Hypoaesthesia - Grade 2 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Memory impairment - Grade 1 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Neuropathy - Grade 1 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Neuropathy peripheral - Grade 1 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Paraesthesia - Grade 1 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Sinus headache - Grade 1 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Somnolence - Grade 1 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Tremor - Grade 1 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Anxiety - Grade 1 | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Confusional state - Grade 1 | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Depression - Grade 1 | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Depression - Grade 2 | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Insomnia - Grade 1 | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Insomnia - Grade 2 | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Mood swings - Grade 1 | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Renal failure - Grade 2 | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 9.1 | View |
| Urinary retention - Grade 1 | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 9.1 | View |
| Asthma - Grade 1 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Cough - Grade 1 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Dysphonia - Grade 1 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Dyspnoea - Grade 1 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Dyspnoea - Grade 2 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Dyspnoea exertional - Grade 1 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Productive cough - Grade 2 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Pulmonary hypertension - Grade 3 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Dry skin - Grade 1 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Erythema - Grade 1 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Hypoaesthesia facial - Grade 1 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Nail disorder - Grade 1 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Night sweats - Grade 1 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Night sweats - Grade 2 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Petechiae - Grade 1 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Pruritus - Grade 1 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Pruritus - Grade 2 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Pruritus generalised - Grade 2 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Rash - Grade 1 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Rash - Grade 2 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Rash generalised - Grade 1 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Rash generalised - Grade 2 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Rash generalised - Grade 3 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Rash pruritic - Grade 1 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Rash pruritic - Grade 3 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Skin exfoliation - Grade 1 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Skin odour abnormal - Grade 1 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Swelling face - Grade 1 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Hypotension - Grade 1 | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 9.1 | View |
| Anaemia - Grade 1 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Leukopenia - Grade 3 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Lymphopenia - Grade 3 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Neutropenia - Grade 4 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Thrombocytopenia - Grade 3 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Diplopia - Grade 2 | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 9.1 | View |
| Vision blurred - Grade 1 | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 9.1 | View |
| Visual disturbance - Grade 1 | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 9.1 | View |
| Anaemia - Grade 2 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Anaemia - Grade 3 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Granulocytopenia - Grade 1 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Lymphadenopathy - Grade 2 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Lymphopenia - Grade 1 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Lymphopenia - Grade 2 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Neutropenia - Grade 1 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Neutropenia - Grade 2 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Neutropenia - Grade 3 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Pancytopenia - Grade 1 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Thrombocytopenia - Grade 1 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Thrombocytopenia - Grade 2 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Bradycardia - Grade 1 | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.1 | View |
| Ear pain - Grade 1 | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 9.1 | View |
| Ear pain - Grade 2 | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 9.1 | View |
| Eye swelling - Grade 1 | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 9.1 | View |
| Vision blurred - Grade 2 | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 9.1 | View |
| Abdominal discomfort - Grade 1 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Abdominal distension - Grade 1 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Abdominal pain upper - Grade 1 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Nasal congestion - Grade 1 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Pharyngolaryngeal pain - Grade 1 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Pneumonitis - Grade 2 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Skin hyperpigmentation - Grade 1 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |