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: 2025-12-25 @ 2:34 AM
Ignite Modification Date: 2025-12-26 @ 1:10 AM
NCT ID: NCT01081834
Description: The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
Frequency Threshold: 5
Time Frame: Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
Study: NCT01081834
Study Brief: The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Main Study (Baseline to Week 26): Cana 100 mg Each patient received 100 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 26. None None 8 195 39 195 View
Main Study (Baseline to Week 26): Cana 300 mg Each patient received 300 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 26. None None 2 197 51 197 View
Main Study (Baseline to Week 52): Placebo/Sitagliptin Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Data are presented for Baseline to Week 52. None None 11 192 63 192 View
Main Study (Baseline to Week 52): Cana 100 mg Each patient received 100 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 52. None None 11 195 54 195 View
Main Study (Baseline to Week 52): Cana 300 mg Each patient received 300 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 52. None None 5 197 69 197 View
High Glycemic Substudy (Baseline to Week 26): Cana 100 mg Each patient received 100 mg of canagliflozin (Cana) once daily for 26 weeks. Data are only available for Baseline to Week 26. None None 0 47 6 47 View
High Glycemic Substudy (Baseline to Week 26): Cana 300 mg Each patient received 300 mg of canagliflozin (Cana) once daily for 26 weeks. Data are only available for Baseline to Week 26. None None 1 44 6 44 View
Main Study (Baseline to Week 26): Placebo Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Data are presented for Baseline to Week 26. None None 4 192 38 192 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 14.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 14.0 View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 14.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 14.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 14.0 View
Ischaemic hepatitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MEDDRA 14.0 View
Abscess limb NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 14.0 View
Bacterial prostatitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 14.0 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 14.0 View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 14.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 14.0 View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 14.0 View
Ankle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 14.0 View
Brain herniation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 14.0 View
Wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 14.0 View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 14.0 View
Haemorrhage intracranial NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 14.0 View
Renal colic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA 14.0 View
Renal failure acute NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA 14.0 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA 14.0 View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDDRA 14.0 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 14.0 View
Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 14.0 View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 14.0 View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 14.0 View
Abdominal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 14.0 View
Inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 14.0 View
Umbilical hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 14.0 View
Liver disorder NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MEDDRA 14.0 View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 14.0 View
Pulmonary tuberculosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 14.0 View
Viral pericarditis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 14.0 View
Skeletal injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 14.0 View
Spinal column injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 14.0 View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 14.0 View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 14.0 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA 14.0 View
Hepatic enzyme increased NON_SYSTEMATIC_ASSESSMENT Investigations MEDDRA 14.0 View
Gastrointestinal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 14.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 14.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 14.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 14.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 14.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 14.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 14.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 14.0 View