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 @ 1:50 PM
Ignite Modification Date: 2025-12-25 @ 12:42 PM
NCT ID: NCT00561795
Description: None
Frequency Threshold: 0
Time Frame: Enrollment to End of Study (up to a year)
Study: NCT00561795
Study Brief: Feasibility Study of Pazopanib in Combination With Chemotherapy in Gynaecological Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
A5-1 Paclitaxel 175 milligrams (mg)/square meter (m\^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study None None 6 6 5 6 View
A5-2 Paclitaxel 175 mg/m\^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study None None 2 6 4 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ileal Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Skin Necrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Haemoglobin Increase SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastric Disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Paraesthesia Oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Tooth Disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Palmar-Plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin Fissures SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Mucosal Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Catheter Related Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Peripheral Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
C-Reactive Protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Haemoglobin Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal Dryness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nervousness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Sleep Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View