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 @ 9:15 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
NCT ID:
NCT03343704
Description:
Treated set (TS): include all patients who are administered with idarucizumab.
Frequency Threshold:
5
Time Frame:
Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Study:
NCT03343704
Study Brief:
This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group A - Patients With Uncontrolled or Life-threatening Bleeding | Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart. Patients who were taking dabigatran etexilate and had uncontrolled or life-threatening bleeding requiring urgent medical or surgical intervention were included in this group. | 0 | None | 7 | 13 | 13 | 13 | View |
| Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure | Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart. Patients included in this group were those who were taking dabigatran etexilate and may not be bleeding, but do require an emergency surgery or other invasive procedure for a condition other than bleeding, where therapeutic anticoagulation with dabigatran etexilate was undesirable. | 1 | None | 3 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Multiple organ dysfunction syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.1 | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Thalamic infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Cardiac failure chronic | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Calculus urinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Hypertensive urgency | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.1 | View |
| Coagulopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.1 | View |
| Hyperfibrinolysis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.1 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Dysbiosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Gastrointestinal disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Cholestasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.1 | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.1 | View |
| Liver injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.1 | View |
| Anal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Pneumonia klebsiella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Post procedural infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Anal injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Cardiac procedure complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Urethral injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Antithrombin III decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Blood alkaline phosphatase decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Blood cholinesterase decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Blood creatinine decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Blood fibrinogen decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Blood fibrinogen increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Blood glucose decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Blood uric acid decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Fibrin D dimer increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Fibrin degradation products increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Gamma-glutamyltransferase decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Heart rate increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| High density lipoprotein decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Lymphocyte percentage decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Monocyte percentage decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Myoglobin blood increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Neutrophil percentage increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Prothrombin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Pulmonary arterial pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Thrombin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Troponin I increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| White blood cell count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Dyslipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Electrolyte imbalance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Hyperlipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Hypernatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Hypochloraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Hypoproteinaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.1 | View |
| Micturition urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.1 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.1 | View |
| Renal cyst | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.1 | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.1 | View |
| Pelvic fluid collection | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 23.1 | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Skin exfoliation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Thrombophlebitis superficial | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Venous thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |