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 @ 2:48 AM
Ignite Modification Date:
2025-12-26 @ 1:29 AM
NCT ID:
NCT02951533
Description:
Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Frequency Threshold:
0
Time Frame:
Up to Week 100
Study:
NCT02951533
Study Brief:
A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
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 I/IIa (Week 0 to Week 32): Guselkumab (GUS) | In Part I, participants received GUS 100 mg treatment administered as 100 mg/mL solution SC at Weeks 0, 4, 12 and 20. Participants who completed treatment phase until Week 24 entered Part II of study. Participants who completed Part I continued to receive GUS 100 mg SC at Week 28 and 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit. | 0 | None | 3 | 60 | 47 | 60 | View |
| Part I/IIa (Week 0 to Week 32): Fumaric Acid Esters (FAE) | In Part I, Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were up-titrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study. Participants who completed Part I and consented for Part IIa continued to receive commercially available FAE tablets specifically labeled for the study from Week 24 through Week 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit. | 0 | None | 2 | 58 | 57 | 58 | View |
| Part IIb (Week 32 Through Week 56): Guselkumab (GUS) | At Week 32 (study Part IIb), PASI 75 response was evaluated and PASI 75 responders and non-responders of guselkumab arm continued to receive guselkumab 100 mg SC every 8 weeks (weeks 36, 44 and 52). Safety follow up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed up 12 weeks after last treatment dose. For all participants who continued study, safety was followed-up at every visit. | 0 | None | 3 | 55 | 43 | 55 | View |
| Part IIb (Week 32 Through Week 56): Fumaric Acid Esters (FAE) | At Week 32, PASI 75 response was evaluated and PASI 75 responders of the FAE arm continued to receive commercially available FAE tablets specifically labeled for the study during Part IIb up to Week 56. Safety follow up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed up 12 weeks after last treatment dose. For all participants who continued study, safety was followed-up at every visit. | 0 | None | 1 | 14 | 13 | 14 | View |
| Part IIb (Week 32 Through Week 56): FAE to Guselkumab | At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to 100 mg guselkumab SC at Weeks 32 and continued at Week 36, 44 and Week 52. Safety follow up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed up 12 weeks after last treatment dose. For all participants who continued study, safety was followed-up at every visit. | 0 | None | 2 | 20 | 14 | 20 | View |
| Part III (Week 64 Through Week 100): Guselkumab | Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100. | 0 | None | 0 | 36 | 2 | 36 | View |
| Part III (Week 64 Through Week 100): FAE to Guselkumab | At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100. | 0 | None | 0 | 12 | 0 | 12 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thymus Enlargement | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 19.1 | View |
| Inguinal Hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Sarcoidosis | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 19.1 | View |
| Lipoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | View |
| Hydronephrosis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 19.1 | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 19.1 | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Clavicle Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Limb Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Post Procedural Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Radius Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Psoriatic Arthropathy | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 19.1 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 19.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 19.1 | View |
| Feeling Hot | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 19.1 | View |
| Inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 19.1 | View |
| Injection Site Rash | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 19.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 19.1 | View |
| Oedema Peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 19.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 19.1 | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 19.1 | View |
| Seasonal Allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 19.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Ear Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Gastrointestinal Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Herpes Zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Onychomycosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Oral Herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Otitis Media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Skin Candida | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Tinea Pedis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Viral Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Bone Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Ligament Sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Post Procedural Haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Post-Traumatic Neck Syndrome | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Sunburn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Traumatic Haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Alanine Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 19.1 | View |
| Aspartate Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 19.1 | View |
| Blood Glucose Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 19.1 | View |
| Gamma-Glutamyltransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 19.1 | View |
| Hepatic Enzyme Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 19.1 | View |
| Human Chorionic Gonadotropin Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 19.1 | View |
| Lymph Node Palpable | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 19.1 | View |
| Transaminases Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 19.1 | View |
| Weight Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 19.1 | View |
| Weight Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 19.1 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 19.1 | View |
| Food Intolerance | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 19.1 | View |
| Hypercholesterolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 19.1 | View |
| Hyperuricaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 19.1 | View |
| Vitamin D Deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 19.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
| Articular Calcification | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
| Muscle Tightness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
| Musculoskeletal Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
| Neck Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
| Pain in Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
| Spinal Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
| Tendonitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
| Giant Cell Tumour of Tendon Sheath | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | View |
| Papilloma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | View |
| Carpal Tunnel Syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 19.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 19.1 | View |
| Dysaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 19.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 19.1 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 19.1 | View |
| Transient Ischaemic Attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 19.1 | View |
| Device Breakage | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA Version 19.1 | View |
| Mood Altered | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 19.1 | View |
| Restlessness | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 19.1 | View |
| Glycosuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 19.1 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 19.1 | View |
| Leukocyturia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 19.1 | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 19.1 | View |
| Renal Failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 19.1 | View |
| Ureterolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 19.1 | View |
| Vaginal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 19.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | View |
| Oropharyngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | View |
| Pharyngeal Erythema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | View |
| Pulmonary Arterial Hypertension | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | View |
| Throat Irritation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Dermatitis Contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Hyperkeratosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Neurodermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Night Sweats | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Polymorphic Light Eruption | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Prurigo | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Rash Erythematous | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Rosacea | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Seborrhoea | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Skin Burning Sensation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Skin Exfoliation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Dental Operation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA Version 19.1 | View |
| Skin Neoplasm Excision | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA Version 19.1 | View |
| Aortic Elongation | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 19.1 | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 19.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 19.1 | View |
| Lymphoedema | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 19.1 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 19.1 | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 19.1 | View |
| Deafness | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 19.1 | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA Version 19.1 | View |
| Eye Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 19.1 | View |
| Hypothermia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 19.1 | View |
| Hepatic Steatosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 19.1 | View |
| Bronchitis Viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Furuncle | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Gastroenteritis Norovirus | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Gastroenteritis Salmonella | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Impetigo | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Periodontitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Pulpitis Dental | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Root Canal Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Rotavirus Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Tooth Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Arthropod Bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Joint Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Limb Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Post Procedural Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Procedural Pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Blood Glucose Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 19.1 | View |
| Breath Sounds Abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 19.1 | View |
| Lymphocyte Count Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 19.1 | View |
| Lymphocyte Morphology Abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 19.1 | View |
| Protein Urine Present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 19.1 | View |
| White Blood Cells Urine Positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 19.1 | View |
| Diabetes Mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 19.1 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 19.1 | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
| Bursitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
| Femoroacetabular Impingement | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
| Intervertebral Disc Protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
| Osteochondrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
| Spinal Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
| Basal Cell Carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | View |
| Dysplastic Naevus | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | View |
| Lipoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | View |
| Skin Papilloma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | View |
| Cervicogenic Vertigo | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 19.1 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 19.1 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 19.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 19.1 | View |
| Ketonuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 19.1 | View |
| Balanoposthitis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 19.1 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Dermatitis Allergic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 19.1 | View |
| Peripheral Venous Disease | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 19.1 | View |
| Defaecation Urgency | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Dry Mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Faeces Soft | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Gastrointestinal Disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Gastrointestinal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Tooth Disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 19.1 | View |
| Eosinophilia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 19.1 | View |
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 19.1 | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 19.1 | View |
| Monocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 19.1 | View |
| Ventricular Extrasystoles | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 19.1 | View |
| Ear Pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 19.1 | View |
| Middle Ear Inflammation | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 19.1 | View |
| Tympanic Membrane Perforation | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 19.1 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 19.1 | View |
| Dry Eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 19.1 | View |
| Visual Acuity Reduced | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 19.1 | View |
| Visual Impairment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 19.1 | View |
| Abdominal Discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Abdominal Distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Abdominal Pain Upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 19.1 | View |