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 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
NCT ID:
NCT03277105
Description:
Safety population included all randomized participants who received at least 1 dose of study drug.
Frequency Threshold:
5
Time Frame:
Up to 3 years
Study:
NCT03277105
Study Brief:
A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory 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 |
|---|---|---|---|---|---|---|---|---|
| Daratumumab IV | Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days. | 130 | None | 89 | 258 | 216 | 258 | View |
| Daratumumab SC | Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Units per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days. | 126 | None | 83 | 260 | 217 | 260 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.1 | View |
| Disseminated Intravascular Coagulation | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.1 | View |
| Hyperviscosity Syndrome | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.1 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.1 | View |
| Acute Coronary Syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 21.1 | View |
| Angina Pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 21.1 | View |
| Atrial Fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 21.1 | View |
| Atrioventricular Block | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 21.1 | View |
| Atrioventricular Block Complete | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 21.1 | View |
| Cardiac Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 21.1 | View |
| Cardiac Failure Chronic | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 21.1 | View |
| Cardiopulmonary Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 21.1 | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 21.1 | View |
| Myocardial Ischaemia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 21.1 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 21.1 | View |
| Deafness Neurosensory | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 21.1 | View |
| Hypoacusis | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 21.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Gastrointestinal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Gingival Bleeding | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Inguinal Hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Oesophageal Varices Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Small Intestinal Obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Subileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.1 | View |
| Chest Discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.1 | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.1 | View |
| General Physical Health Deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.1 | View |
| Multiple Organ Dysfunction Syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.1 | View |
| Performance Status Decreased | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.1 | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 21.1 | View |
| Acute Hepatitis B | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Bronchiolitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Campylobacter Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Corona Virus Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Device Related Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Hepatitis B Reactivation | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Listeriosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Lower Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Lung Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Mastoiditis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Meningitis Cryptococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Meningitis Pneumococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Pneumocystis Jirovecii Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Respiratory Syncytial Virus Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Rhinovirus Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Septic Shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Staphylococcal Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.1 | View |
| Femoral Neck Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.1 | View |
| Femur Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.1 | View |
| Humerus Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.1 | View |
| Subdural Haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.1 | View |
| Upper Limb Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.1 | View |
| Oxygen Saturation Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 21.1 | View |
| Hypercalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 21.1 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 21.1 | View |
| Hypernatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 21.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Bone Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Muscular Weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Myofascial Pain Syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Neck Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Pain in Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Pathological Fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Rhabdomyolysis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Spinal Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Trismus | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Adenocarcinoma of Colon | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | View |
| Colon Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | View |
| Gastric Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | View |
| Lung Neoplasm Malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | View |
| Metastases to Liver | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | View |
| Oesophageal Squamous Cell Carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | View |
| Plasmacytoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | View |
| Tumour Associated Fever | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | View |
| Brain Oedema | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.1 | View |
| Cerebral Infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.1 | View |
| Cerebrovascular Accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.1 | View |
| Cerebrovascular Insufficiency | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.1 | View |
| Iiird Nerve Paralysis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.1 | View |
| Monoparesis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.1 | View |
| Peripheral Sensory Neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.1 | View |
| Spinal Cord Compression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.1 | View |
| Transient Ischaemic Attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.1 | View |
| Confusional State | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 21.1 | View |
| Acute Kidney Injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 21.1 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 21.1 | View |
| Myeloma Cast Nephropathy | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 21.1 | View |
| Renal Failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 21.1 | View |
| Pelvic Pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 21.1 | View |
| Bronchospasm | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | View |
| Chronic Obstructive Pulmonary Disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | View |
| Lung Disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | View |
| Pulmonary Embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | View |
| Pulmonary Oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | View |
| Pulmonary Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | View |
| Respiratory Failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | View |
| Circulatory Collapse | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 21.1 | View |
| Deep Vein Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 21.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 21.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 21.1 | View |
| Febrile Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Escherichia Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Furuncle | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Neutropenic Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Blood Pressure Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 21.1 | View |
| General Physical Condition Abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 21.1 | View |
| Prostate Cancer Recurrent | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | View |
| Thyroid Neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.1 | View |
| Respiratory Distress | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.1 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.1 | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.1 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.1 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.1 | View |
| Oedema Peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 21.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Bone Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Musculoskeletal Chest Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Musculoskeletal Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Pain in Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 21.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | View |
| Nasal Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 21.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |