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 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
NCT ID:
NCT02951156
Description:
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study drug.
Frequency Threshold:
5
Time Frame:
Baseline up to follow up (36 months)
Study:
NCT02951156
Study Brief:
Avelumab In Combination Regimens That Include An Immune Agonist, Epigenetic Modulator, CD20 Antagonist and/or Conventional Chemotherapy in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Avelumab+Rituximab+Utomilumab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m\^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days. | 4 | None | 3 | 8 | 8 | 8 | View |
| Avelumab+Azacitidine+Utomilumab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Azacitidine 40 mg/m\^2 SC dose was administered on Days 1 to 5 of each treatment cycle until the participant no longer received clinical benefit, along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days. | 8 | None | 6 | 9 | 9 | 9 | View |
| Avelumab+Bendamustine+Rituximab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m\^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m\^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days. | 6 | None | 7 | 11 | 11 | 11 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v22.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.1 | View |
| Disease progression | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.1 | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v22.1 | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Hypercalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.1 | View |
| Laryngeal oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | View |
| Non-Hodgkin's lymphoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.1 | View |
| Ophthalmic herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.1 | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Septic shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Small intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.1 | View |
| Superior vena cava syndrome | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v22.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v22.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.1 | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.1 | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v22.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Amylase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v22.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v22.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.1 | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v22.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | View |
| Bilirubin conjugated increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Blood alkaline phosphatase | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Blood calcium | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Blood chloride increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Blood cholesterol increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Blood triglycerides increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.1 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.1 | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | View |
| Confusional state | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v22.1 | View |
| Conjunctival haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v22.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.1 | View |
| Decubitus ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.1 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v22.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v22.1 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | View |
| Dyspnoea exertional | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.1 | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Generalised oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.1 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v22.1 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Head discomfort | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Hiatus hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.1 | View |
| Hypercalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.1 | View |
| Hypercholesterolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.1 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.1 | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.1 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.1 | View |
| Hypermagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.1 | View |
| Hypernatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v22.1 | View |
| Hypertriglyceridaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.1 | View |
| Hyperuricaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.1 | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.1 | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.1 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.1 | View |
| Hypomagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.1 | View |
| Hypophosphataemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v22.1 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.1 | View |
| Infusion related reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.1 | View |
| Injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.1 | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.1 | View |
| Joint range of motion decreased | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | View |
| Lacrimation increased | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v22.1 | View |
| Lethargy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v22.1 | View |
| Lipase decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Lymph node pain | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v22.1 | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.1 | View |
| Microalbuminuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v22.1 | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.1 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v22.1 | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Night sweats | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.1 | View |
| Nocturia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v22.1 | View |
| Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.1 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.1 | View |
| Oesophageal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.1 | View |
| Ophthalmic herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Pollakiuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v22.1 | View |
| Post procedural haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.1 | View |
| Primary hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v22.1 | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v22.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.1 | View |
| Pulmonary oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.1 | View |
| Rash erythematous | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.1 | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.1 | View |
| Rash papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.1 | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v22.1 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | View |
| Sinus bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v22.1 | View |
| Skin abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.1 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.1 | View |
| Superior vena cava syndrome | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v22.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v22.1 | View |
| Taste disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v22.1 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.1 | View |
| Transfusion reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.1 | View |
| Tumour pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.1 | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Electrocardiogram QT prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |