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 @ 4:52 PM
Ignite Modification Date:
2025-12-25 @ 2:35 PM
NCT ID:
NCT03431350
Description:
The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Frequency Threshold:
5
Time Frame:
Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months
Study:
NCT03431350
Study Brief:
A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg | Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study. | 6 | None | 2 | 6 | 6 | 6 | View |
| Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg | Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study. | 5 | None | 3 | 6 | 6 | 6 | View |
| Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg | Participants with mCRPC and were BM+ received established recommended Phase 2 dose (RP2D) of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study. | 18 | None | 12 | 21 | 21 | 21 | View |
| Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg | Participants with mCRPC and were BM- received established RP2D of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study. | 7 | None | 6 | 11 | 11 | 11 | View |
| Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone | Participants with mCRPC and HRR gene alterations (breast cancer gene \[BRCA\] biallelic loss \[2A\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone (P) 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study. | 5 | None | 4 | 8 | 8 | 8 | View |
| Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone | Participants with mCRPC and HRR gene alterations (BRCA monoallelic loss \[2C\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study. | 4 | None | 5 | 9 | 9 | 9 | View |
| Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone | Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss \[2D\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study. | 2 | None | 1 | 6 | 5 | 6 | View |
| Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone | Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study. | 0 | None | 1 | 1 | 1 | 1 | View |
| Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | Participants with mCRPC (regardless of HRR BM status) received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as single agent (SA) orally from Cycle 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (Pharmacokinetic \[PK\] Assessment Phase), Participants had the option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation. | 3 | None | 4 | 17 | 10 | 17 | View |
| Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 as fixed-dose combination 1 (FDC1) regular-strength (RS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation. | 1 | None | 4 | 17 | 10 | 17 | View |
| Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) | Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC2 RS tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation. | 4 | None | 7 | 17 | 6 | 17 | View |
| Combination 3: Cohort 3: Niraparib + Abiraterone Acetate, FDC1-LS | Participants with mCRPC received a single oral dose of niraparib 100 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC1 low strength (LS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation. | 2 | None | 3 | 17 | 5 | 17 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Tumour Compression | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.1 | View |
| Tumour Pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.1 | View |
| Non-Cardiac Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Peripheral Swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Arthritis Bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Corona Virus Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Enterocolitis Infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Herpes Simplex Encephalitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Pyonephrosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Urosepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Viral Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Femur Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.1 | View |
| Humerus Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.1 | View |
| Lower Limb Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.1 | View |
| Spinal Compression Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.1 | View |
| Blood Creatinine Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Cachexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Diabetic Ketoacidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Hypercalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Hypomagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Muscular Weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Myositis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Osteoporosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Cerebral Ischaemia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Cerebrovascular Accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Spinal Cord Compression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Device Dislocation | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA Version 22.1 | View |
| Device Occlusion | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA Version 22.1 | View |
| Acute Kidney Injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 22.1 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 22.1 | View |
| Hydronephrosis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 22.1 | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 22.1 | View |
| Pelvic Pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 22.1 | View |
| Prostatitis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 22.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Pharyngeal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Pleural Effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Pulmonary Embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 22.1 | View |
| Pelvic Venous Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 22.1 | View |
| Localised Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 22.1 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 22.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 22.1 | View |
| Atrial Fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 22.1 | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA Version 22.1 | View |
| Abdominal Distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Anal Fistula | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Lower Gastrointestinal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| General Physical Health Deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 22.1 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 22.1 | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 22.1 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 22.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 22.1 | View |
| Angina Pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 22.1 | View |
| Atrial Fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 22.1 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 22.1 | View |
| Sinus Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 22.1 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 22.1 | View |
| Ear Pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 22.1 | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 22.1 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 22.1 | View |
| Adrenal Insufficiency | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA Version 22.1 | View |
| Hyperthyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA Version 22.1 | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA Version 22.1 | View |
| Eye Pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 22.1 | View |
| Eye Swelling | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 22.1 | View |
| Ocular Hyperaemia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 22.1 | View |
| Abdominal Distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Diverticulum | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Dry Mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Gastrointestinal Angiodysplasia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Gastrooesophageal Reflux Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Gingival Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Hiatus Hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Lip Dry | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Mouth Ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Oral Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Retching | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Tongue Coated | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Chest Discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Influenza Like Illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Injection Site Swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Non-Cardiac Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Oedema Peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Peripheral Swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Temperature Intolerance | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 22.1 | View |
| Candida Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Eye Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Herpes Zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Oral Candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Oral Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Tooth Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Urosepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Viral Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Viral Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.1 | View |
| Muscle Strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.1 | View |
| Procedural Pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.1 | View |
| Radiation Proctitis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.1 | View |
| Skin Abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.1 | View |
| Skin Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.1 | View |
| Alanine Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Alpha 1 Globulin Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Alpha 2 Globulin Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Aspartate Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Blood Alkaline Phosphatase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Blood Chloride Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Blood Corticotrophin Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Blood Corticotrophin Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Blood Creatinine Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Blood Lactate Dehydrogenase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Blood Pressure Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Blood Thyroid Stimulating Hormone Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Blood Thyroid Stimulating Hormone Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Blood Urea Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Cortisol Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Fibrin D Dimer Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Gamma-Glutamyltransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Lipase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Thyroxine Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Thyroxine Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Tri-Iodothyronine Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Troponin T Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Vitamin D Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Weight Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Abnormal Loss of Weight | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Hyperamylasaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Hypomagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Polydipsia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Bone Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Bursitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Flank Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Foot Deformity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Joint Swelling | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Muscle Spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Muscular Weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Musculoskeletal Chest Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Musculoskeletal Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Musculoskeletal Stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Neck Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Osteoporosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Pain in Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Melanocytic Naevus | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.1 | View |
| Metastases to Bone | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.1 | View |
| Tumour Pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.1 | View |
| Amnesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Dysaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Facial Neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Mental Impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Peripheral Motor Neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Peripheral Sensory Neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Spinal Cord Compression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Taste Disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.1 | View |
| Mood Altered | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.1 | View |
| Chromaturia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 22.1 | View |
| Chronic Kidney Disease | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 22.1 | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 22.1 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 22.1 | View |
| Micturition Urgency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 22.1 | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 22.1 | View |
| Pollakiuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 22.1 | View |
| Polyuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 22.1 | View |
| Renal Impairment | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 22.1 | View |
| Urinary Incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 22.1 | View |
| Urinary Retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 22.1 | View |
| Urinary Tract Obstruction | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 22.1 | View |
| Urine Flow Decreased | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 22.1 | View |
| Gynaecomastia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 22.1 | View |
| Pelvic Discomfort | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 22.1 | View |
| Pelvic Pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 22.1 | View |
| Testicular Pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 22.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Dysphonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Dyspnoea Exertional | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Hiccups | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Nasal Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Oropharyngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Productive Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Pulmonary Embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Rhinitis Allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Sinus Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Sneezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Upper-Airway Cough Syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Petechiae | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Photosensitivity Reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Purpura | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Rash Maculo-Papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Skin Burning Sensation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Skin Exfoliation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Skin Hyperpigmentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Skin Lesion | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Deep Vein Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 22.1 | View |
| Embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 22.1 | View |
| Hot Flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 22.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 22.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 22.1 | View |
| Lymphoedema | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 22.1 | View |
| Orthostatic Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 22.1 | View |