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 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
NCT ID:
NCT02014051
Description:
All participants who received at least one dose of SyB C-1101.
Frequency Threshold:
0
Time Frame:
Up to 18 weeks for each dosing cohort
Study:
NCT02014051
Study Brief:
Safety and Pharmacokinetics Study of SyB C-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| SyB C-1101 280 mg/Dose Group | Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period. The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles. The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics. | None | None | 1 | 3 | 3 | 3 | View |
| SyB C-1101 560 mg/Dose Group | Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period. The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles. The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics. | None | None | 3 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cholecystitis | None | Hepatobiliary disorders | MedDRA (17.1) | View |
| Periodontitis | None | Infections and infestations | MedDRA (17.1) | View |
| Urinary tract infection | None | Infections and infestations | MedDRA (17.1) | View |
| Pneumonia | None | Infections and infestations | MedDRA (17.1) | View |
| Soft tissue infection | None | Infections and infestations | MedDRA (17.1) | View |
| Type 2 diabetes mellitus | None | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| Delirium | None | Psychiatric disorders | MedDRA (17.1) | View |
| Haematuria | None | Renal and urinary disorders | MedDRA (17.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infection | None | Infections and infestations | MedDRA (17.1) | View |
| Anaemia | None | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Constipation | None | Gastrointestinal disorders | MedDRA (17.1) | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA (17.1) | View |
| Gastrointestinal pain | None | Gastrointestinal disorders | MedDRA (17.1) | View |
| Ileus | None | Gastrointestinal disorders | MedDRA (17.1) | View |
| Stomatitis | None | Gastrointestinal disorders | MedDRA (17.1) | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA (17.1) | View |
| Anal haemorrhage | None | Gastrointestinal disorders | MedDRA (17.1) | View |
| CD4 lymphocytes decreased | None | Investigations | MedDRA (17.1) | View |
| Electrocardiogram QT prolonged | None | Investigations | MedDRA (17.1) | View |
| Haemoglobin decreased | None | Investigations | MedDRA (17.1) | View |
| Abdominal pain | None | Gastrointestinal disorders | MedDRA (17.1) | View |
| Dyspepsia | None | Gastrointestinal disorders | MedDRA (17.1) | View |
| Pyrexia | None | General disorders | MedDRA (17.1) | View |
| Thirst | None | General disorders | MedDRA (17.1) | View |
| Cystitis | None | Infections and infestations | MedDRA (17.1) | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA (17.1) | View |
| Pharyngitis | None | Infections and infestations | MedDRA (17.1) | View |
| Alanine aminotransferase increased | None | Investigations | MedDRA (17.1) | View |
| Aspartate aminotransferase increased | None | Investigations | MedDRA (17.1) | View |
| Lymphocyte count decreased | None | Investigations | MedDRA (17.1) | View |
| Neutrophil count decreased | None | Investigations | MedDRA (17.1) | View |
| Red blood cell count decreased | None | Investigations | MedDRA (17.1) | View |
| Reticulocyte count decreased | None | Investigations | MedDRA (17.1) | View |
| Weight decreased | None | Investigations | MedDRA (17.1) | View |
| White blood cell count decreased | None | Investigations | MedDRA (17.1) | View |
| Dehydration | None | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| Flank pain | None | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Hypoaesthesia | None | Nervous system disorders | MedDRA (17.1) | View |
| Insomnia | None | Psychiatric disorders | MedDRA (17.1) | View |
| Restlessness | None | Psychiatric disorders | MedDRA (17.1) | View |
| Urinary tract disorder | None | Renal and urinary disorders | MedDRA (17.1) | View |
| Cystitis noninfective | None | Renal and urinary disorders | MedDRA (17.1) | View |