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 @ 9:23 PM
Ignite Modification Date: 2025-12-25 @ 7:09 PM
NCT ID: NCT04745832
Description: 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Frequency Threshold: 0
Time Frame: The occurrence of adverse events was assessed for 1 year, 7 months
Study: NCT04745832
Study Brief: Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rituximab Plus Zandelisib Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles Zandelisib: Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3 Rituximab: Rituximab IV 375 mg/m2 for 6 cycles In the Rituximab plus Zandelisib arm, 41 subjects enrolled 1 None 12 41 38 41 View
Rituximab Plus Chemotherapy Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles Rituximab: Rituximab IV 375 mg/m2 for 6 cycles Bendamustine: Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles CHOP: Cyclophosphamide, Vindcristine IV, and Prednisone daily orally In the R-chemo arm 31 subjects were enrolled to R-B and 10 to R=CHOP 1 None 8 41 37 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Liver disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Pneumocystis jirovecii pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Vascular device infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Cytomegalovirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Breast cancer female SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Suspected Infection of unknown origin SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Supraventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24 View
Vertigo positional SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24 View
Goitre SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24 View
Hyperparathyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24 View
Corneal disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Anal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Injection site phlebitis SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24 View
Liver disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24 View
Hypogammaglobulinaemia SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Cytomegalovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Cytomegalovirus infection reactivation SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Gastrointestinal fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Infected cyst SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Nail infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Pneumocystis jirovecii pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Pneumonia cytomegaloviral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Vascular device infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Chillblains SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Heat stroke SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Beta 2 microglobulin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Cytomegalovirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Electrocardiogram QRS complex prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Impaired fasting glucose SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24 View
Musculoskeletal discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24 View
Breast cancer female SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Hypertonic bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Intermenstrual bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24 View
Bronchopneumopathy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Pharyngeal swelling SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Pulmonary alveolar haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Nail discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Pruritus allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Skin mass SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24 View
Suspected Infection of unknown origin SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
AST ALT increase SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View