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 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
NCT ID:
NCT01200758
Description:
Safety Analysis Population included all participants who received at least one dose of rituximab, either IV or SC. Safety Analysis Population included 6 participants who were randomized under Rituximab SC arm but withdrew after Cy1 and then analyzed under Rituximab IV arm.
Frequency Threshold:
5
Time Frame:
Baseline up to data cutoff date of 31 Oct 2017 (up to 6 years)
Study:
NCT01200758
Study Brief:
A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months. | None | None | 76 | 210 | 187 | 210 | View |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | First cycle of rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months. | None | None | 74 | 197 | 186 | 197 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenic sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Bacterial prostatitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Creutzfeldt-Jakob disease | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Empyema | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Gastroenteritis norovirus | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Giardiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Meningitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Otitis externa | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Pneumocystis jirovecii pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Pneumonia mycoplasmal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Postoperative wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Urinary tract infection bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Oral lichen planus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Colitis ulcerative | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Duodenal ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Ileus paralytic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Mouth ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Proctalgia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Acute respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Multi-organ failure | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Acute coronary syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Cardiac failure congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Myocardial ischaemia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Stress fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Ankle fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| Femoral neck fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| Foreign body | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Multiple injuries | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Coma hepatic | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Hydrocephalus | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Sciatica | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Basal cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | View |
| Prostate cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| Rectal adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| Squamous cell carcinoma of lung | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | View |
| Squamous cell carcinoma of skin | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | View |
| Thyroid cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.1) | View |
| Tumour lysis syndrome | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.1) | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Lichen planus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Skin ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Arterial occlusive disease | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.1) | View |
| Hypertensive crisis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.1) | View |
| Vena cava thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Eastern Cooperative Oncology Group performance status worsened | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| International normalised ratio increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| Hydronephrosis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (16.1) | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.1) | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (18.1) | View |
| Cholangitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (16.1) | View |
| Cholecystitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (16.1) | View |
| Major depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.1) | View |
| Pelvic cyst | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.1) | View |
| Mesenteric vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Abdominal wall haematoma | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Large intestine polyp | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Jaundice | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (18.1) | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Urosepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Chronic hepatitis B | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Erysipelas | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Hepatitis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Intestinal sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Pulmonary tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Respiratory tract infection fungal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| Lumbar vertebral fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| Traumatic intracranial haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| Wrist fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Adenocarcinoma of colon | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| Cervix Carcinoma Stage 0 | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| Colon cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| Kaposi's sarcoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| Lung neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| Myelodysplastic syndrome | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| Renal cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| Uterine leiomyoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| Cognitive disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Hypoglycaemic coma | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Transient ischaemic attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Bipolar disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.1) | View |
| Ovarian cyst | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.1) | View |
| Uterovaginal prolapse | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.1) | View |
| Bronchitis chronic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| Subclavian artery occlusion | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.1) | View |
| Bladder calculus removal | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (18.1) | View |
| Hysterectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (18.1) | View |
| Calculus bladder | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.1) | View |
| Uterine polyp | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.1) | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| Cellulitis gangrenous | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| Breast cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| Plasma cell myeloma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| Squamous cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Skull fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Pathological fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Mucosal inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Injection site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.1) | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.1) | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.1) | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Neuropathy peripheral | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.1) | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.1) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.1) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.1) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.1) | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.1) | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.1) | View |