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 @ 2:24 AM
Ignite Modification Date: 2025-12-26 @ 12:57 AM
NCT ID: NCT04035434
Description: The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
Frequency Threshold: 0
Time Frame: Up to 5 years
Study: NCT04035434
Study Brief: A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)
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 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10\^7 CAR+ T cells. 3 None 3 3 3 3 View
Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells. 2 None 2 3 3 3 View
Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells. 4 None 1 6 6 6 View
Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10\^8 CAR+ T cells. 3 None 1 6 6 6 View
Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells. 9 None 5 10 10 10 View
Phase 1/2: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1. 21 None 8 35 34 35 View
Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells. 1 None 0 1 1 1 View
Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3x10\^8 CAR+ T cells. 3 None 1 5 5 5 View
Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells. 4 None 4 5 5 5 View
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells. 4 None 3 4 4 4 View
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells. 2 None 3 5 5 5 View
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) B Cell ALL: Cohort D: DL 4 (6\*10\^8 CAR+ T Cells) Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells. 1 None 1 7 7 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Immune effector cell-associated neurotoxicity syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Hypertensive encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Hypercalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Pancytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Hepatic failure NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Device related infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Enterococcal bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Staphylococcal bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Facial paralysis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Renal tubular necrosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Hepatic encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Respiratory syncytial virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Bronchopulmonary aspergillosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Enterococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Escherichia sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Periorbital cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pseudomonal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Upper gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Venoocclusive liver disease NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Myelodysplastic syndrome NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Neurotoxicity NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Cytokine release syndrome NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 27.0 View
Haemophagocytic lymphohistiocytosis NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 27.0 View
Rectal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Renal vein thrombosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tumour associated fever NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Lymphoedema NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Orthostatic hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Catheter site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Face oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Feeling abnormal NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Cytokine release syndrome NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 27.0 View
Hypogammaglobulinaemia NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 27.0 View
Genital cyst NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 27.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Lung infiltration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Pulmonary cavitation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Rhinitis allergic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Sinus disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Tachypnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Dyspnoea exertional NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 27.0 View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Hallucination, auditory NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Blood fibrinogen decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Cardiac murmur NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood potassium increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Troponin I increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Immune effector cell-associated neurotoxicity syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Lethargy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Disturbance in attention NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Anosmia NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Dysaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Dysarthria NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Muscle spasticity NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Neuralgia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Neuropathy peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Taste disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Tension headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Methaemoglobinaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Lymph node pain NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Deafness unilateral NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 27.0 View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 27.0 View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Conjunctival haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Diplopia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Eye irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Vitreous haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Anal incontinence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Haemorrhoidal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Paraesthesia oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Retching NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Hypertransaminasaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Hepatic vascular thrombosis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Nail discolouration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Skin exfoliation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Erythema multiforme NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Night sweats NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Rash macular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Hydronephrosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Nocturia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Urinary hesitation NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Renal vein thrombosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Adrenal insufficiency NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 27.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Joint effusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Respiratory syncytial virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pneumonia moraxella NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Viruria NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Bacterial disease carrier NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Escherichia urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Rhinovirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Tooth abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypophosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperchloraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypertriglyceridaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypoalbuminaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypercalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperphosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypervolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Magnesium deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Catheter site swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Sinus bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Supraventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Ear discomfort NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 27.0 View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Haematemesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Proctalgia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Catheter site thrombosis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Injection site reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Generalised oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Graft versus host disease NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 27.0 View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Clostridium difficile infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Staphylococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Urinary tract infection bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
International normalised ratio increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood magnesium decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
CD4 lymphocytes decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Lymph node palpable NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Respiratory syncytial virus test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Hepatic encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Sleep disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Cystitis haemorrhagic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Postmenopausal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 27.0 View
Pharyngeal erythema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Rhinalgia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Drug reaction with eosinophilia and systemic symptoms NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Hallucination NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View