Adverse Events Module

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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 @ 1:45 AM
Ignite Modification Date: 2025-12-26 @ 12:03 AM
NCT ID: NCT01381094
Description: Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Frequency Threshold: 5
Time Frame: Up to Week 8 (Follow-up Visit 2 weeks after last dose)
Study: NCT01381094
Study Brief: 42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AKB-6548 500 mg Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days. 0 None 1 17 8 17 View
AKB-6548 630 mg Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days. 0 None 1 19 11 19 View
Placebo Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days. 0 None 1 19 11 19 View
AKB-6548 370 mg Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days. 1 None 3 18 5 18 View
AKB-6548 240 mg Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days. 0 None 2 18 9 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Azotaemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Cardiac pacemaker replacement SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 13.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 13.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 13.0 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 13.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 13.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 13.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 13.0 View
Ear haemorrhage SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDra 13.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDra 13.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 13.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 13.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 13.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 13.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 13.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 13.0 View
Frequent bowel movements SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 13.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 13.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 13.0 View
Adverse drug reaction SYSTEMATIC_ASSESSMENT General disorders MedDra 13.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDra 13.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDra 13.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDra 13.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 13.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 13.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 13.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 13.0 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 13.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 13.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 13.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 13.0 View
Joint sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 13.0 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 13.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 13.0 View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 13.0 View
Blood glucose decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 13.0 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDra 13.0 View
Transferrin saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 13.0 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 13.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 13.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 13.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 13.0 View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 13.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 13.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 13.0 View
Vitamin d deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 13.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 13.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 13.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 13.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 13.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 13.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 13.0 View
Eczema asteatotic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 13.0 View
Hair texture abnormal SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 13.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 13.0 View
Seborrhoeic dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 13.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 13.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 13.0 View
Wound infection pseudomonas SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 13.0 View