Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
NCT ID:
NCT04358458
Description:
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
Frequency Threshold:
0
Time Frame:
Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
Study:
NCT04358458
Study Brief:
First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part 1: GEN3009 Dose Level A in S1 | Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. | 1 | None | 0 | 3 | 3 | 3 | View |
| Part 1: GEN3009 Dose Level B in S1 | Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. | 1 | None | 0 | 4 | 4 | 4 | View |
| Part 1: GEN3009 Dose Level C in S1 | Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. | 3 | None | 4 | 7 | 7 | 7 | View |
| Part 1: GEN3009 Dose Level D in S1 | Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2. | 8 | None | 7 | 10 | 9 | 10 | View |
| Part 1: GEN3009 Dose Level D in S2 | Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle. | 1 | None | 2 | 3 | 3 | 3 | View |
| Part 1: GEN3009 Dose Level E in S1 | Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 8 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2. | 6 | None | 4 | 10 | 10 | 10 | View |
| Part 1: GEN3009 Dose Level F in S1 | Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2. | 2 | None | 2 | 3 | 3 | 3 | View |
| Part 1: GEN3009 Dose Level G in S1 | Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2. | 3 | None | 4 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Malignant melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Aphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| COVID-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Groin pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.0 | View |
| Staphylococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Urinary tract pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Scleral haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Rhinovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Restless legs syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Cytomegalovirus infection reactivation | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Refractive amblyopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Anosmia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| CD4 lymphocytes decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Injection site phlebitis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Blood creatine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Scrotal pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.0 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 26.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Skin atrophy | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Lymph node pain | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Candida infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Lymphocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Meralgia paraesthetica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Vascular access complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Hypogammaglobulinaemia | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Cancer pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Aphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Feeling jittery | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| Diplopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| Vein disorder | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Malnutrition | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Scratch | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Gingival pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Periorbital oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Steroid diabetes | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Phlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| Dermoid cyst | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 26.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Dizziness postural | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Hypermagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| International normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Coordination abnormal | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Infusion site paraesthesia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |