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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 11:37 PM
NCT ID:
NCT00810693
Description:
None
Frequency Threshold:
2
Time Frame:
Adverse event data were collected after signing the informed consent until 2 days after end of study treatment over a period of approximately 30 days.
Study:
NCT00810693
Study Brief:
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT | Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks | None | None | 29 | 254 | 216 | 254 | View |
| Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT | Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks | None | None | 11 | 63 | 57 | 63 | View |
| Placebo | Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks | None | None | 23 | 126 | 96 | 126 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| Atrioventricular block | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Cardiac failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Cardiomegaly | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Right ventricular failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Supraventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Retinal artery occlusion | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Haematemesis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Irritable bowel syndrome | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Intra-abdominal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Bronchopneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Diarrhoea infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Encephalitis herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Tooth infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Enterocolitis infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Mycoplasma infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Muscle rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Subdural haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Catheterisation cardiac | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Electrocardiogram ST-T segment abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| Metastatic malignant melanoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Loss of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Renal failure acute | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| Vaginal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.0) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Haemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Interstitial lung disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Pulmonary congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Pulmonary hypertension | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Pulmonary arterial hypertension | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Circulatory collapse | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Gastric polyps | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Face oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Feeling hot | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Activated partial thromboplastin time prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| International normalised ratio increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Hyperuricaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| Iron deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Pharyngeal inflammation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Hot flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |