Adverse Events Module

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 @ 1:39 AM
Ignite Modification Date: 2025-12-25 @ 11:55 PM
NCT ID: NCT03397394
Description: None
Frequency Threshold: 5
Time Frame: Adverse events for each patient were reported from the first dose until 28 days after last dose of study drug, and the total study time for adverse event reporting was approximately 19 months.
Study: NCT03397394
Study Brief: Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HRD Unknown Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown. 9 None 20 47 45 47 View
HRD Negative Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH \< 10% were considered HRD-negative. 8 None 14 30 29 30 View
HRD Positive Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive. 7 None 11 20 19 20 View
Overall All patients 24 None 45 97 93 97 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (20.1) View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (20.1) View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (20.1) View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (20.1) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View
Gastric ulcer perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.1) View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.1) View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.1) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.1) View
Hepatocellular injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (20.1) View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.1) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.1) View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.1) View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.1) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.1) View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.1) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.1) View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.1) View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (20.1) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.1) View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.1) View
Pubic pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.1) View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (20.1) View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (20.1) View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (20.1) View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (20.1) View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (20.1) View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (20.1) View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (20.1) View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (20.1) View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (20.1) View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (20.1) View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (20.1) View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (20.1) View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (20.1) View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (20.1) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (20.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (20.1) View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (20.1) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (20.1) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (20.1) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View
Anorectal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.1) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.1) View
Localized oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.1) View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.1) View
Nodule SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.1) View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.1) View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.1) View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.1) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.1) View
Bacterial vaginosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.1) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.1) View
Sialoadenitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.1) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.1) View
Back injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (20.1) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (20.1) View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (20.1) View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (20.1) View
Toxicity to various agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (20.1) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (20.1) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (20.1) View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (20.1) View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (20.1) View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (20.1) View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (20.1) View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (20.1) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (20.1) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (20.1) View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (20.1) View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (20.1) View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (20.1) View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (20.1) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (20.1) View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (20.1) View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (20.1) View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (20.1) View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (20.1) View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (20.1) View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (20.1) View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (20.1) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.1) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.1) View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.1) View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.1) View
Muscle twitching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.1) View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.1) View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.1) View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.1) View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.1) View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.1) View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (20.1) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (20.1) View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (20.1) View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (20.1) View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (20.1) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (20.1) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (20.1) View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (20.1) View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (20.1) View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (20.1) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (20.1) View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (20.1) View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (20.1) View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (20.1) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (20.1) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (20.1) View
Intermittent claudication SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (20.1) View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (20.1) View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (20.1) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View
Swollen tongue SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.1) View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.1) View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.1) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (20.1) View