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 @ 4:46 PM
Ignite Modification Date:
2025-12-25 @ 2:32 PM
NCT ID:
NCT03054350
Description:
None
Frequency Threshold:
5
Time Frame:
up to Week 18
Study:
NCT03054350
Study Brief:
Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Primary Efficacy Period: 150 mg Vadadustat | Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks. | 8 | None | 0 | 15 | 8 | 15 | View |
| Primary Efficacy Period: 300 mg Vadadustat | Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks. | 11 | None | 0 | 15 | 11 | 15 | View |
| Primary Efficacy Period: 600 mg Vadadustat | Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks. | 6 | None | 3 | 15 | 5 | 15 | View |
| Primary Efficacy Period: Placebo Matched to 150 mg Vadadustat | Participants were randomized to receive matching placebo for 6 weeks. | 2 | None | 0 | 5 | 2 | 5 | View |
| Primary Efficacy Period: Placebo Matched to 300 mg Vadadustat | Participants were randomized to receive matching placebo for 6 weeks. | 2 | None | 1 | 5 | 2 | 5 | View |
| Primary Efficacy Period: Placebo Matched to 600 mg Vadadustat | Participants were randomized to receive matching placebo for 6 weeks. | 2 | None | 0 | 5 | 2 | 5 | View |
| Dose Adjustment and Maintenance: 150 mg Vadadustat | Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target hemoglobin (Hb) of 10.0 to 12.0 grams/deciliter (g/dL) based on dose adjustment guidelines. | 9 | None | 1 | 15 | 9 | 15 | View |
| Dose Adjustment and Maintenance: 300 mg Vadadustat | Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines. | 9 | None | 1 | 15 | 9 | 15 | View |
| Dose Adjustment and Maintenance: 600 mg Vadadustat | Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines. | 9 | None | 1 | 15 | 9 | 15 | View |
| Dose Adjustment and Maintenance: Placebo to 150 mg Vadadustat | Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines. | 1 | None | 0 | 5 | 1 | 5 | View |
| Dose Adjustment and Maintenance: Placebo to 300 mg Vadadustat | Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines. | 1 | None | 0 | 5 | 1 | 5 | View |
| Dose Adjustment and Maintenance: Placebo to 600 mg Vadadustat | Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines. | 2 | None | 0 | 5 | 2 | 5 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pericarditis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Gastric ulcer haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Cholecystitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 20.0 | View |
| Enteritis infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Arteriovenous fistula site complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Shunt stenosis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Cerebral haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Toxic encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Faeces soft | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Pancreatic cyst | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Tracheobronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Foreign body | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Shunt stenosis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Blood parathyroid hormone increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Skin papilloma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Neurodermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Anaemia macrocytic | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.0 | View |
| Enterocolitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Catheter site erosion | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Vessel puncture site pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 20.0 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Gingivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Periodontitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Arteriovenous fistula site complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Thermal burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Vascular graft stenosis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Blood pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Blood uric acid decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Tenosynovitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Diabetic neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Post herpetic neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Restless legs syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Rhinitis allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Sleep apnoea syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Dermal cyst | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Ingrowing nail | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Rash pruritic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.0 | View |
| Cardiac failure chronic | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Diabetic retinopathy | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Upper respiratory tract inflammation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |