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 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
NCT ID:
NCT03170518
Description:
Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.
Frequency Threshold:
5
Time Frame:
Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56)
Study:
NCT03170518
Study Brief:
A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo | Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin \[HbA1c\] of greater than or equal to (\>=)7.0 percent \[%\], estimated glomerular filtration rate \[eGFR\] \>=60 milliliter per minute per 1.73 meter square \[mL/min/1.73 m\^2\]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52. | 0 | None | 5 | 87 | 45 | 87 | View |
| Canagliflozin 100 mg | Participants received canagliflozin 100 mg tablet orally once daily from Day 1 till Week 12. Participants who met re-randomization criteria (HbA1c of \>=7.0%, estimated eGFR \>=60 mL/min/1.73 m\^2) at Week 12 were alone re-randomized at Week 13 in a 1:1 ratio to receive 1 tablet of canagliflozin 100 mg tablet orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of canagliflozin 100 mg orally once daily till Week 52. | 0 | None | 7 | 67 | 37 | 67 | View |
| Canagliflozin 300 mg | Participants received canagliflozin 100 mg tablet orally once daily from Day 1 till Week 12. Participants who met re-randomization criteria (HbA1c of \>=7.0%, estimated eGFR \>=60 mL/min/1.73 m\^2) at Week 12 were alone re-randomized at Week 13 in a 1:1 ratio to receive 1 tablet of canagliflozin 300 mg tablet orally and 1 tablet of placebo matching canagliflozin 100 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of canagliflozin 100 mg orally once daily till Week 52. | 0 | None | 1 | 17 | 14 | 17 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pancreatitis Acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.0 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 26.0 | View |
| Anaphylactic Reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 26.0 | View |
| Erysipelas | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Ankle Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.0 | View |
| Diabetes Mellitus Inadequate Control | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Diabetic Ketoacidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Abortion Spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA Version 26.0 | View |
| Suicide Attempt | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 26.0 | View |
| Tonsillar Hypertrophy | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | View |
| Pancreatitis Acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.0 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 26.0 | View |
| Anaphylactic Reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 26.0 | View |
| Erysipelas | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Ankle Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.0 | View |
| Diabetes Mellitus Inadequate Control | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Diabetic Ketoacidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Abortion Spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA Version 26.0 | View |
| Suicide Attempt | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 26.0 | View |
| Tonsillar Hypertrophy | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bacterial Vaginosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Balanitis Candida | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Covid-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| External Ear Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Gastroenteritis Viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Genital Herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Genital Herpes Simplex | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Genital Infection Fungal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Pharyngitis Streptococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Pharyngotonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Urinary Tract Infection Bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Viral Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Viral Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Vulvovaginal Candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Skin Abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.0 | View |
| Skin Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.0 | View |
| Blood Glucose Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.0 | View |
| Blood Ketone Body Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.0 | View |
| High Density Lipoprotein Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Diabetes Mellitus Inadequate Control | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Hypertriglyceridaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Vitamin D Deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Musculoskeletal Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 26.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 26.0 | View |
| Autism Spectrum Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 26.0 | View |
| Ketonuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 26.0 | View |
| Balanoposthitis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 26.0 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | View |
| Skin Lesion | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 26.0 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.0 | View |
| Thirst | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.0 | View |
| Seasonal Allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 26.0 | View |
| Bacterial Vaginosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Balanitis Candida | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Covid-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| External Ear Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Gastroenteritis Viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Genital Herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Genital Herpes Simplex | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Genital Infection Fungal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Pharyngitis Streptococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Pharyngotonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Urinary Tract Infection Bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Viral Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Viral Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Vulvovaginal Candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Skin Abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.0 | View |
| Skin Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.0 | View |
| Blood Glucose Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.0 | View |
| Blood Ketone Body Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.0 | View |
| High Density Lipoprotein Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Diabetes Mellitus Inadequate Control | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Hypertriglyceridaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Vitamin D Deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Musculoskeletal Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 26.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 26.0 | View |
| Autism Spectrum Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 26.0 | View |
| Ketonuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 26.0 | View |
| Balanoposthitis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 26.0 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | View |
| Skin Lesion | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 26.0 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.0 | View |
| Thirst | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.0 | View |
| Seasonal Allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 26.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.0 | View |