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 @ 10:32 PM
Ignite Modification Date: 2025-12-25 @ 8:05 PM
NCT ID: NCT01292135
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01292135
Study Brief: Safety and Tolerability Study of PCI-32765 Combined With Fludarabine/Cyclophosphamide/Rituximab (FCR) and Bendamustine/Rituximab (BR) in Chronic Lymphocytic Leukemia (CLL)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PCI-32765 Plus Bendamustine/Rituximab (BR) PCI-32765: 420 mg daily None None 6 30 30 30 View
PCI-32765 Plus Fludarabine/ Cyclophosphamide/Rituximab (FCR) PCI-32765: 420 mg daily None None 1 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia None Blood and lymphatic system disorders None View
Cellulitis None Infections and infestations None View
Dehydration None Metabolism and nutrition disorders None View
Tumour lysis syndrome None Metabolism and nutrition disorders None View
Gastritis None Gastrointestinal disorders None View
Viral Infection None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotension None Vascular disorders None View
Neutropenia None Blood and lymphatic system disorders None View
Thrombocytopenia None Blood and lymphatic system disorders None View
Anaemia None Blood and lymphatic system disorders None View
Conjuctivitis None Eye disorders None View
Diarrhoea None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Gastrooesophageal reflux disease None Gastrointestinal disorders None View
Abdominal discomfort None Gastrointestinal disorders None View
Dry mouth None Gastrointestinal disorders None View
Stomatitis None Gastrointestinal disorders None View
Abdominal distension None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Flatulence None Gastrointestinal disorders None View
Mouth ulceration None Gastrointestinal disorders None View
Tongue ulcerlation None Gastrointestinal disorders None View
Fatigue None General disorders None View
Oedema peripheral None General disorders None View
Pyrexia None General disorders None View
Chills None General disorders None View
Asthenia None General disorders None View
Pain None General disorders None View
Chest discomfort None General disorders None View
Impaired healing None General disorders None View
Drug hypersensitivity None Immune system disorders None View
Seasonal allergy None Immune system disorders None View
Upper respiratory tract infection None Infections and infestations None View
Sinusitis None Infections and infestations None View
Urinary tract infection None Infections and infestations None View
Cellulitis None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Pneomonia None Infections and infestations None View
Contusion None Injury, poisoning and procedural complications None View
Arthropod bite None Injury, poisoning and procedural complications None View
Weight decreased None Investigations None View
Blood uric acid increased None Investigations None View
Decreased appetite None Metabolism and nutrition disorders None View
Hyperuricaemia None Metabolism and nutrition disorders None View
Hypomagnesaemia None Metabolism and nutrition disorders None View
Hyperglycaemia None Metabolism and nutrition disorders None View
Hypocalcaemia None Metabolism and nutrition disorders None View
Fluid retention None Metabolism and nutrition disorders None View
Hypophosphataemia None Metabolism and nutrition disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Muscle spasms None Musculoskeletal and connective tissue disorders None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Bone pain None Musculoskeletal and connective tissue disorders None View
Pain in extremity None Musculoskeletal and connective tissue disorders None View
Muscular weakness None Musculoskeletal and connective tissue disorders None View
Squamous cell carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Basal cell carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Headache None Nervous system disorders None View
Dizziness None Nervous system disorders None View
Paraesthesia None Nervous system disorders None View
Syncope None Nervous system disorders None View
Insomnia None Psychiatric disorders None View
Depression None Psychiatric disorders None View
Haematuria None Renal and urinary disorders None View
Pollakiuria None Renal and urinary disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain None Respiratory, thoracic and mediastinal disorders None View
Sinus congestion None Respiratory, thoracic and mediastinal disorders None View
Epistaxis None Respiratory, thoracic and mediastinal disorders None View
Nasal congestion None Respiratory, thoracic and mediastinal disorders None View
Rash maculo papular None Skin and subcutaneous tissue disorders None View
Increased tendency to bruise None Skin and subcutaneous tissue disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Dermatitis None Skin and subcutaneous tissue disorders None View
Ecchymosis None Skin and subcutaneous tissue disorders None View
Onychoclasis None Skin and subcutaneous tissue disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Sunburn None Skin and subcutaneous tissue disorders None View
Flushing None Vascular disorders None View
Oral herpes None Infections and infestations None View
Rhinitis None Infections and infestations None View
Skin Infection None Infections and infestations None View
Joint dislocation None Injury, poisoning and procedural complications None View
Hyponatraemia None Metabolism and nutrition disorders None View
Musculoskeletal pain None Musculoskeletal and connective tissue disorders None View
Neck Pain None Musculoskeletal and connective tissue disorders None View