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 @ 7:22 PM
Ignite Modification Date:
2025-12-25 @ 5:01 PM
NCT ID:
NCT04711603
Description:
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
Frequency Threshold:
5
Time Frame:
Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Study:
NCT04711603
Study Brief:
A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Double Blind Period: MR13A9 0.5 μg/kg Group | MR13A9 was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total). The dose of the study drug was determined according to mentioned below based on the subject's dry weight before dialysis on the start day of the screening period. 1. \<45.0 kg: 17.5 μg 2. \>=45.0 kg, \<65.0 kg: 25.0 μg 3. \>=65.0 kg, \<85.0 kg: 35.0 μg 4. \>=85.0 kg: 42.5 μg | 0 | None | 7 | 89 | 27 | 89 | View |
| Double Blind Period: Placebo Group | Placebo was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total). The dose of the study drug was determined according to mentioned below based on the subject's dry weight before dialysis on the start day of the screening period. 1. \<45.0 kg: 0 μg 2. \>=45.0 kg, \<65.0 kg: 0 μg 3. \>=65.0 kg, \<85.0 kg: 0 μg 4. \>=85.0 kg: 0 μg | 1 | None | 10 | 89 | 24 | 89 | View |
| Entire Study: MR-MR Group | \[Double-blind period (6 weeks)\] The subjects in this group received the investigational drug for 6 weeks as the MR13A9 0.5 μg/kg group. \[Extension period (52 weeks)\] The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 52 weeks (3 times weekly, 156 times in total). The dose of the study drug was determined according to mentioned below, and the dose of the study drug from Week 6 to immediately before Week 34 will be determined based on the subject's dry weight before dialysis at Week 6. The dose of the study drug after Week 34 will be determined based on the subject's dry weight before dialysis at Week 34. The study drug (MR13A9) will not be administered at Week 58. 1. \<45.0 kg: 17.5 μg 2. \>=45.0 kg, \<65.0 kg: 25.0 μg 3. \>=65.0 kg, \<85.0 kg: 35.0 μg 4. \>=85.0 kg: 42.5 μg | 2 | None | 33 | 85 | 74 | 85 | View |
| Entire Study: P-MR Group | \[Double-blind period (6 weeks)\] The subjects in this group received the investigational drug for 6 weeks as the Placebo group. \[Extension period (52 weeks)\] The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 52 weeks (3 times weekly, 156 times in total). The dose of the study drug was determined according to mentioned below, and the dose of the study drug from Week 6 to immediately before Week 34 will be determined based on the subject's dry weight before dialysis at Week 6. The dose of the study drug after Week 34 will be determined based on the subject's dry weight before dialysis at Week 34. The study drug (MR13A9) will not be administered at Week 58. 1. \<45.0 kg: 17.5 μg 2. \>=45.0 kg, \<65.0 kg: 25.0 μg 3. \>=65.0 kg, \<85.0 kg: 35.0 μg 4. \>=85.0 kg: 42.5 μg | 2 | None | 38 | 83 | 74 | 83 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |
| COVID-19 pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |
| Cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.1 | View |
| Immune thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 23.1 | View |
| Nephrogenic anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 23.1 | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.1 | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.1 | View |
| Angina unstable | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.1 | View |
| Cardiac failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.1 | View |
| Cardiac failure acute | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.1 | View |
| Coronary artery stenosis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.1 | View |
| Myocardial ischaemia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.1 | View |
| Paroxysmal atrioventricular block | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.1 | View |
| Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.1 | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 23.1 | View |
| Anal prolapse | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Colitis ischaemic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Diverticular perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Enterocolitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Gastric polyps | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Gastric ulcer haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Haematemesis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Inguinal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.1 | View |
| Cholangitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 23.1 | View |
| Cholecystitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 23.1 | View |
| Hepatic function abnormal | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 23.1 | View |
| Liver injury | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 23.1 | View |
| Anaphylactic shock | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA version 23.1 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |
| Renal cyst infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |
| Shunt infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |
| Tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |
| Cataract operation complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.1 | View |
| Shunt aneurysm | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.1 | View |
| Shunt occlusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.1 | View |
| Shunt stenosis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.1 | View |
| Blood pressure decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.1 | View |
| Diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.1 | View |
| Lumbar spinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | View |
| Osteonecrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | View |
| Spinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | View |
| Spondylitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | View |
| Chronic myeloid leukaemia | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | View |
| Clear cell renal cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | View |
| Gastric cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | View |
| Renal cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | View |
| Brain stem infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.1 | View |
| Status epilepticus | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.1 | View |
| Aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | View |
| Pneumonia aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | View |
| Skin ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | View |
| Large intestinal polypectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA version 23.1 | View |
| Aortic stenosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 23.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 23.1 | View |
| Peripheral arterial occlusive disease | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 23.1 | View |
| Cardiac failure congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.1 | View |
| Shunt stenosis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.1 | View |
| Skin abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.1 | View |
| Vaccination complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.1 | View |
| Wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.1 | View |
| Diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 23.1 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | View |
| Hyperkeratosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | View |
| Dialysis hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 23.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Vaccination site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |