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 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
NCT ID:
NCT03015220
Description:
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Frequency Threshold:
5
Time Frame:
Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Study:
NCT03015220
Study Brief:
Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Oral Semaglutide 14 mg | Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52. | 0 | None | 7 | 130 | 84 | 130 | View |
| Oral Semaglutide 3 mg | Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52. | 0 | None | 9 | 131 | 65 | 131 | View |
| Oral Semaglutide 7 mg | Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52. | 0 | None | 4 | 132 | 79 | 132 | View |
| Dulaglutide 0.75 mg | Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52. | 0 | None | 1 | 65 | 36 | 65 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20 | View |
| Atrioventricular block second degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20 | View |
| Cardiac ablation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 20 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20 | View |
| Colorectal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | View |
| Diabetic retinopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20 | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20 | View |
| Gastrointestinal inflammation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20 | View |
| Ischaemic cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20 | View |
| Large intestine polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20 | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20 | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | View |
| Rotator cuff syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20 | View |
| Shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20 | View |
| Sudden hearing loss | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20 | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20 | View |
| Colon adenoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | View |
| Rectal adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | View |
| Spinal operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 20 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20 | View |
| Diabetic retinopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20 | View |
| Upper respiratory tract inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20 | View |