Adverse Events Module

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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 @ 8:01 PM
Ignite Modification Date: 2025-12-25 @ 5:34 PM
NCT ID: NCT02190604
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT02190604
Study Brief: Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part 1 QBW251 25mg Part 1 QBW251 25mg None None 0 6 2 6 View
Part 1 QBW251 150mg Part 1 QBW251 150mg None None 0 6 1 6 View
Part 1 QBW251 300mg Part 1 QBW251 300mg None None 0 6 2 6 View
Part 1 QBW251 500mg Part 1 QBW251 500mg None None 0 6 2 6 View
Part 1 QBW251 500mg (Fed) Part 1 QBW251 500mg (fed) None None 0 5 1 5 View
Part 1 QBW251 750mg Part 1 QBW251 750mg None None 0 6 1 6 View
Part 1 QBW251 1000mg Part 1 QBW251 1000mg None None 0 6 4 6 View
Part 2 Placebo Part 2 Placebo None None 0 10 7 10 View
Part 2 QBW251 150mg Part 2 QBW251 150mg None None 0 6 3 6 View
Part 2 QBW251 400mg Part 2 QBW251 400mg None None 0 6 6 6 View
Part 2 QBW251 750mg Part 2 QBW251 750mg None None 0 6 3 6 View
Part 2 QBW251 450mg BID Part 2 QBW251 450mg BID None None 0 6 6 6 View
Part 2 QBW251 750mg BID Part 2 QBW251 750mg BID None None 0 6 4 6 View
Part 3 Placebo C1/C2/C3 Part 3 Placebo C1/C2/C3 None None 0 12 8 12 View
Part 3 QBW251 150mg BID C1 Part 3 QBW251 150mg BID C1 None None 1 6 5 6 View
Part 3 QBW251 450mg BID C2 Part 3 QBW251 450mg BID C2 None None 1 12 8 12 View
Part 3 QBW251 450mg BID C3 Part 3 QBW251 450mg BID C3 None None 1 19 18 19 View
Part 1 Placebo Part 1 Placebo None None 0 16 8 16 View
Part 1 QBW251 10mg Part 1 QBW251 10mg None None 0 6 3 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
VITAMIN D DEFICIENCY SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
SINUS CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
SNEEZING SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PALPITATIONS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
ICHTHYOSIS SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
EAR DISCOMFORT SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
EAR PAIN SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
TINNITUS SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
ABDOMINAL DISCOMFORT SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL DISTENSION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL PAIN LOWER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
APHTHOUS STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
FAECES DISCOLOURED SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
FLATULENCE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
GINGIVAL DISORDER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
SALIVA ALTERED SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
SALIVARY GLAND PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
CHEST DISCOMFORT SYSTEMATIC_ASSESSMENT General disorders MedDRA View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA View
PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA View
PERIPHERAL SWELLING SYSTEMATIC_ASSESSMENT General disorders MedDRA View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
SENSATION OF FOREIGN BODY SYSTEMATIC_ASSESSMENT General disorders MedDRA View
THIRST SYSTEMATIC_ASSESSMENT General disorders MedDRA View
VESSEL PUNCTURE SITE BRUISE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
BRONCHOPULMONARY ASPERGILLOSIS ALLERGIC SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
FOLLICULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
FUNGAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
ORAL HERPES SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
PHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
VIRAL UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
ARTHROPOD BITE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
LIGAMENT SPRAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
SKIN WOUND SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
ADENOVIRUS TEST POSITIVE SYSTEMATIC_ASSESSMENT Investigations MedDRA View
BLOOD ALKALINE PHOSPHATASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
BLOOD POTASSIUM DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
BREATH SOUNDS ABNORMAL SYSTEMATIC_ASSESSMENT Investigations MedDRA View
CORONAVIRUS TEST POSITIVE SYSTEMATIC_ASSESSMENT Investigations MedDRA View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPOGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
JOINT SWELLING SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCULOSKELETAL CHEST PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCULOSKELETAL PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCULOSKELETAL STIFFNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
NECK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
BALANCE DISORDER SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
HYPERAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
PRESYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
SCIATICA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
TREMOR SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
AGITATION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
STRESS SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
CHROMATURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
GLYCOSURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
PROTEINURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
BRONCHIAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
HAEMOPTYSIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
NASAL DISCOMFORT SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PAINFUL RESPIRATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PRODUCTIVE COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PULMONARY CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
RHINORRHOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
SPUTUM INCREASED SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
THROAT IRRITATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
TONSILLAR DISORDER SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
ERYTHEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
HEAT RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
NIGHT SWEATS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
PHOTOSENSITIVITY REACTION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
PRURITUS GENERALISED SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
RASH ERYTHEMATOUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
RASH PRURITIC SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
URTICARIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
HOT FLUSH SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View