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 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
NCT ID:
NCT03467932
Description:
Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Frequency Threshold:
0
Time Frame:
Each subject was followed for a period of 12 weeks
Study:
NCT03467932
Study Brief:
A Study to Evaluate the Efficacy and Safety of ORMD-0801 (Oral Insulin) in Patients 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 |
|---|---|---|---|---|---|---|---|---|
| Combined Cohort A + Cohort B: Matched Placebo | Placebo matched to one of the three active comparator arms. (either QHS, BID, or TID) Placebo oral capsule: Placebo provided QHS, BID, TID Per FDA, the sub-Cohort A, excipient-matched placebo TID is an exploratory arm and is not part of the primary analysis. | 0 | None | 0 | 82 | 11 | 82 | View |
| Cohort A: ORMD-0801 Once Daily - QD | Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia. | 0 | None | 5 | 69 | 19 | 69 | View |
| Cohort A: ORMD-0801 Twice Daily - BID | Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia. | 0 | None | 0 | 68 | 6 | 68 | View |
| Cohort B: ORMD-0801 8 mg Twice Daily - BID | ORMD-0801 8 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia. | 0 | None | 0 | 17 | 2 | 17 | View |
| Excipient Matched Placebo -TID | Exploratory endpoint not part of primary analysis per FDA | 1 | None | 3 | 20 | 13 | 20 | View |
| Cohort B: ORMD-0801 16 mg Once Daily - QD | ORMD-0801 16 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia. | 0 | None | 0 | 18 | 1 | 18 | View |
| Cohort B: ORMD-0801 16 mg Twice Daily - BID | ORMD-0801 16 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia. | 0 | None | 1 | 15 | 2 | 15 | View |
| Cohort A: ORMD-0801 Three Times Daily - TID | ORMD-0801 three times daily - TID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch. Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia. | 0 | None | 3 | 69 | 10 | 69 | View |
| Cohort B:ORMD-0801, 8 mg Once Daily - QD | ORMD-0801 8 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia. | 0 | None | 0 | 15 | 5 | 15 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Supraventricular Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Acute Kidney Injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (21.1) | View |
| Acute Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| Angina Pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Coronary Artery Disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Chronic Obstructive Pulmonary Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| Angina Pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Atrioventricular Block First Degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Atypical Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Mulscle Spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Pain in Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.1) | View |
| Vulvovaginal Discomfort | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (21.1) | View |
| Peripheral Arterial Occlusive Disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (21.1) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Skin Ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Intracardiac Mass | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Supraventricular Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Abdominal pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Large Intestine Polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Pancreatic Cyst | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (21.1) | View |
| Seasonal Allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (21.1) | View |
| Acute Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Adenoviral upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Body Tinea | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Gastroenteritis Viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Dispepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |