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 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
NCT ID:
NCT02148718
Description:
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Frequency Threshold:
0
Time Frame:
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
Study:
NCT02148718
Study Brief:
Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s Disease
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Adalimumab | Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4). | None | None | 2 | 86 | 35 | 86 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (17.1) | View |
| Eyelid disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.1) | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.1) | View |
| Presbyopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.1) | View |
| Abdominal mass | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Aphthous ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Crohn's disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Subileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (17.1) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Herpes virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Pharyngotonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Rash pustular | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Rotavirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Blood triglycerides increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Sacroiliitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.1) | View |