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 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
NCT ID:
NCT01700335
Description:
None
Frequency Threshold:
0
Time Frame:
Up to 16 weeks
Study:
NCT01700335
Study Brief:
Safety and Pharmacokinetics Study of SyB L-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 L-1101 1200 mg/Day Group | Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period. The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles. | None | None | 0 | 3 | 3 | 3 | View |
| SyB L-1101 1800 mg/Day Group | Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period. The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles. | None | None | 2 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Meningitis | None | Infections and infestations | MedDRA (18.0) | View |
| Sepsis | None | Infections and infestations | MedDRA (18.0) | View |
| Device related infection | None | Infections and infestations | MedDRA (18.0) | View |
| Pneumonia bacterial | None | Infections and infestations | MedDRA (18.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blood chloride decreased | None | Investigations | MedDRA (18.0) | View |
| Blood creatinine increased | None | Investigations | MedDRA (18.0) | View |
| Haematuria | None | Renal and urinary disorders | MedDRA (18.0) | View |
| Pollakiuria | None | Renal and urinary disorders | MedDRA (18.0) | View |
| Anaemia | None | Blood and lymphatic system disorders | MedDRA (18.0) | View |
| Febrile neutropenia | None | Blood and lymphatic system disorders | MedDRA (18.0) | View |
| Atrioventricular block second degree | None | Cardiac disorders | MedDRA (18.0) | View |
| Chronic gastritis | None | Gastrointestinal disorders | MedDRA (18.0) | View |
| Constipation | None | Gastrointestinal disorders | MedDRA (18.0) | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA (18.0) | View |
| Gastritis | None | Gastrointestinal disorders | MedDRA (18.0) | View |
| Nausea | None | Gastrointestinal disorders | MedDRA (18.0) | View |
| Tongue haematoma | None | Gastrointestinal disorders | MedDRA (18.0) | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA (18.0) | View |
| Fatigue | None | General disorders | MedDRA (18.0) | View |
| Injection site reaction | None | General disorders | MedDRA (18.0) | View |
| Malaise | None | General disorders | MedDRA (18.0) | View |
| Oedema | None | General disorders | MedDRA (18.0) | View |
| Pyrexia | None | General disorders | MedDRA (18.0) | View |
| Thirst | None | General disorders | MedDRA (18.0) | View |
| Catheter site haemorrhage | None | General disorders | MedDRA (18.0) | View |
| Catheter site pain | None | General disorders | MedDRA (18.0) | View |
| Catheter site pruritus | None | General disorders | MedDRA (18.0) | View |
| Catheter site haematoma | None | General disorders | MedDRA (18.0) | View |
| Infusion site extravasation | None | General disorders | MedDRA (18.0) | View |
| Herpes zoster | None | Infections and infestations | MedDRA (18.0) | View |
| Rash pustular | None | Infections and infestations | MedDRA (18.0) | View |
| Urinary tract infection | None | Infections and infestations | MedDRA (18.0) | View |
| Muscle abscess | None | Infections and infestations | MedDRA (18.0) | View |
| Device related infection | None | Infections and infestations | MedDRA (18.0) | View |
| Accident | None | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Fall | None | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Overdose | None | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Alanine aminotransferase increased | None | Investigations | MedDRA (18.0) | View |
| Aspartate aminotransferase increased | None | Investigations | MedDRA (18.0) | View |
| Blood albumin decreased | None | Investigations | MedDRA (18.0) | View |
| Blood bilirubin increased | None | Investigations | MedDRA (18.0) | View |
| Blood calcium decreased | None | Investigations | MedDRA (18.0) | View |
| Blood urea increased | None | Investigations | MedDRA (18.0) | View |
| Blood uric acid decreased | None | Investigations | MedDRA (18.0) | View |
| C-reactive protein increased | None | Investigations | MedDRA (18.0) | View |
| CD4 lymphocytes decreased | None | Investigations | MedDRA (18.0) | View |
| Gamma-glutamyltransferase increased | None | Investigations | MedDRA (18.0) | View |
| Haemoglobin decreased | None | Investigations | MedDRA (18.0) | View |
| Lymphocyte count decreased | None | Investigations | MedDRA (18.0) | View |
| Neutrophil count decreased | None | Investigations | MedDRA (18.0) | View |
| Platelet count decreased | None | Investigations | MedDRA (18.0) | View |
| Protein total decreased | None | Investigations | MedDRA (18.0) | View |
| Red blood cell count decreased | None | Investigations | MedDRA (18.0) | View |
| Weight decreased | None | Investigations | MedDRA (18.0) | View |
| White blood cell count decreased | None | Investigations | MedDRA (18.0) | View |
| Neutrophil percentage decreased | None | Investigations | MedDRA (18.0) | View |
| Lymphocyte percentage increased | None | Investigations | MedDRA (18.0) | View |
| Protein urine present | None | Investigations | MedDRA (18.0) | View |
| Blood alkaline phosphatase increased | None | Investigations | MedDRA (18.0) | View |
| Hepatitis B DNA assay positive | None | Investigations | MedDRA (18.0) | View |
| Hypochloraemia | None | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Hypokalaemia | None | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Hyponatraemia | None | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Decreased appetite | None | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Somnolence | None | Nervous system disorders | MedDRA (18.0) | View |
| Delirium | None | Psychiatric disorders | MedDRA (18.0) | View |
| Insomnia | None | Psychiatric disorders | MedDRA (18.0) | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Hiccups | None | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Laryngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Pleural effusion | None | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Upper respiratory tract inflammation | None | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Oropharyngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Dermatitis contact | None | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| Purpura | None | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |