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 @ 6:51 PM
Ignite Modification Date:
2025-12-25 @ 4:24 PM
NCT ID:
NCT00157157
Description:
Median days on study was 498 (range: 82 to 1360) days. Median days of rAHF-PFM exposure was 76 (range: 1 to 414) exposure days.
Frequency Threshold:
5
Time Frame:
Study period was to be at least 75 exposure days or 3 years (whichever came first)
Study:
NCT00157157
Study Brief:
Efficacy and Safety Study of a Recombinant Protein-Free Manufactured Factor VIII (rAHF-PFM) in Previously Untreated Hemophilia A Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| PUPs | None | None | None | 28 | 55 | 52 | 55 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Factor VIII inhibition | None | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Coagulopathy | None | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Mouth injury | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Pyrexia | None | General disorders | MedDRA (Unspecified) | View |
| Bacteraemia | None | Infections and infestations | MedDRA (Unspecified) | View |
| Bronchial hyperreactivity | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Bronchitis | None | Infections and infestations | MedDRA (Unspecified) | View |
| Catheter bacteraemia | None | Infections and infestations | MedDRA (Unspecified) | View |
| Catheter related infection | None | Infections and infestations | MedDRA (Unspecified) | View |
| Catheter site haematoma | None | General disorders | MedDRA (Unspecified) | View |
| Contusion | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Dehydration | None | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Haemarthrosis | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Haematoma | None | Vascular disorders | MedDRA (Unspecified) | View |
| Head injury | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Pneumonia | None | Infections and infestations | MedDRA (Unspecified) | View |
| Respiratory syncytial virus infection | None | Infections and infestations | MedDRA (Unspecified) | View |
| Skin laceration | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Tongue injury | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Wheezing | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pyrexia | None | General disorders | MedDRA (Unspecified) | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA (Unspecified) | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Rhinorrhoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Diarrhea | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Ear infection | None | Infections and infestations | MedDRA (Unspecified) | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Upper respiratory tract infection | None | Infections and infestations | MedDRA (Unspecified) | View |
| Nasal congestion | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Anaemia | None | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Conjuctivitis | None | Eye disorders | MedDRA (Unspecified) | View |
| Procedural pain | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Dermatitis diaper | None | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Otitis media | None | Infections and infestations | MedDRA (Unspecified) | View |
| Wheezing | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Hand-foot-and-mouth disease | None | Infections and infestations | MedDRA (Unspecified) | View |
| Iron deficiency anaemia | None | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Urticaria | None | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Arthropod bite | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Bronchitis | None | Infections and infestations | MedDRA (Unspecified) | View |
| Influenza | None | Infections and infestations | MedDRA (Unspecified) | View |
| Pain | None | General disorders | MedDRA (Unspecified) | View |
| Pharyngitis | None | Infections and infestations | MedDRA (Unspecified) | View |
| Rhinitis | None | Infections and infestations | MedDRA (Unspecified) | View |
| Varicella | None | Infections and infestations | MedDRA (Unspecified) | View |
| Abdominal pain | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Croup infectious | None | Infections and infestations | MedDRA (Unspecified) | View |
| Ear pain | None | Ear and labyrinth disorders | MedDRA (Unspecified) | View |
| Gasteroenteritis | None | Infections and infestations | MedDRA (Unspecified) | View |
| Mouth injury | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Oropharyngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Skin laceration | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Viral infection | None | Infections and infestations | MedDRA (Unspecified) | View |