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 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
NCT ID:
NCT02473393
Description:
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs.
All subjects receiving at least 1 dose of IMP were included in the safety set.
Frequency Threshold:
5
Time Frame:
From the start day of IMP administration up to Day 38
Study:
NCT02473393
Study Brief:
A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| CDI Group | OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days. | 0 | None | 0 | 5 | 3 | 5 | View |
| EI Group (50 mg) | OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days. The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step. | 0 | None | 0 | 12 | 4 | 12 | View |
| EI Group (100 mg) | OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days. The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step. | 0 | None | 1 | 13 | 8 | 13 | View |
| EI Group (200 mg) | OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days. The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step. | 0 | None | 0 | 12 | 4 | 12 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Ver. 19.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 19.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 19.0 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Ver. 19.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Ver. 19.0 | View |
| Hepatic steatosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Ver. 19.0 | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 19.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 19.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 19.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver. 19.0 | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver. 19.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Ver. 19.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Ver. 19.0 | View |
| Hypertriglyceridaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Ver. 19.0 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Ver. 19.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Ver. 19.0 | View |
| Chondrocalcinosis pyrophosphate | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Ver. 19.0 | View |
| Musculoskeletal stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Ver. 19.0 | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Ver. 19.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 19.0 | View |
| Intercostal neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 19.0 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 19.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Ver. 19.0 | View |
| Dysmenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Ver. 19.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 19.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 19.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Ver. 19.0 | View |
| Eosinophilia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Ver. 19.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 19.0 | View |
| Cardiac failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Ver. 19.0 | View |