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 @ 10:00 PM
Ignite Modification Date: 2025-12-25 @ 7:37 PM
NCT ID: NCT01209832
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01209832
Study Brief: A Tasisulam and Midazolam Drug Interaction Study in Cancer 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
Midazolam Period 1 (7 days): 1.2 milligrams (mg) midazolam orally on Day 1. None None 0 10 7 10 View
Tasisulam and Midazolam Period 2 (28 days): Tasisulam intravenously to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms per milliliter (h\*mcg/mL) on Day 1 and 1.2 mg midazolam orally on Day 8. None None 1 10 9 10 View
Tasisulam (M1) Maintenance Period 1 (35 days): Tasisulam was dosed intravenously to target AUCalb in the range of 1200 to 6400 h\*mcg/mL on Day 1. None None 0 4 2 4 View
Tasisulam (M2) Maintenance Period 2 (35 days): Tasisulam was dosed intravenously to target AUCalb in the range of 1200 to 6400 h\*mcg/mL on Day 1. None None 0 3 2 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Thrombotic thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Dermatitis bullous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View