Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:15 PM
Ignite Modification Date: 2025-12-25 @ 2:13 PM
NCT ID: NCT02156466
Description: None
Frequency Threshold: 0
Time Frame: Baseline up to Day 85
Study: NCT02156466
Study Brief: Multiple Ascending Dose Trial of MSB0010841 (Anti-IL17A/F Nanobody) in Psoriasis Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MSB0010841 30 mg MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks. None None 1 8 5 8 View
MSB0010841 60 mg MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks. None None 0 8 5 8 View
MSB0010841 120 mg MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks. None None 0 8 5 8 View
MSB0010841 240 mg MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks. None None 0 9 6 9 View
Placebo Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks. None None 0 8 6 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute vestibular syndrome NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Lacrimation increased NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Hypoaesthesia oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Injection site reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Injection site swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Injection site urticaria NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Biliary colic NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Bacterial vaginosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Paronychia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Sunburn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Fibrin D dimer increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood cholesterol increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood creatine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Glucose urine present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Hepatic enzyme increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood creatine phosphokinase MB increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood glucose increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood iron decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
C-reactive protein increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Haemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Protein urine present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Urine ketone body present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Sleep disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Leukocyturia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Catarrh NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Pruritus generalised NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Psoriasis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View