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 @ 5:52 PM
Ignite Modification Date:
2025-12-25 @ 3:17 PM
NCT ID:
NCT00624468
Description:
ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).
Frequency Threshold:
5
Time Frame:
Baseline up to Week 48
Study:
NCT00624468
Study Brief:
Atacicept in Subjects With Optic Neuritis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Atacicept: SFU Period | Participants who received atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial. | None | None | 2 | 14 | 10 | 14 | View |
| Placebo: Double-blind Period | Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks. | None | None | 0 | 17 | 14 | 17 | View |
| Atacicept: Double-blind Period | Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks. | None | None | 0 | 17 | 16 | 17 | View |
| Placebo: SFU Period | Participants who received placebo matched to atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial. | None | None | 1 | 13 | 6 | 13 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Myelitis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Blister | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Bacterial pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Multiple sclerosis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Myelitis transverse | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Tongue disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Aerophagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Faecal incontinence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Vomiting in pregnancy | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Bursitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Musculoskeletal stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Rash pustular | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Syphilis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Viral pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.0) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.0) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.0) | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Tracheal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Dysphonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Pulmonary congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Eye pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (13.0) | View |
| Asthenopia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (13.0) | View |
| Eye haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (13.0) | View |
| Uhthoff's phenomenon | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (13.0) | View |
| Visual acuity reduced | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (13.0) | View |
| Photopsia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (13.0) | View |
| Vitreous floaters | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (13.0) | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.0) | View |
| Liver function test abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.0) | View |
| Weight increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.0) | View |
| Blood glucose increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.0) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Rosacea | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Pruritus allergic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Bundle branch block right | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Ventricular arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (13.0) | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (13.0) | View |
| Dysmenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (13.0) | View |
| Galactorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (13.0) | View |
| Ovarian cyst | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (13.0) | View |
| Arthropod bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Arthropod sting | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Muscle strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Bone fissure | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Concussion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Road traffic accident | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (13.0) | View |
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (13.0) | View |
| Anaemia of pregnancy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (13.0) | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (13.0) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.0) | View |
| Hypertensive crisis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.0) | View |
| Pollakiuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.0) | View |
| Stress urinary incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.0) | View |
| Urinary incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.0) | View |
| Lipoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Skin papilloma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Drug hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (13.0) | View |
| Food allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (13.0) | View |
| Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (13.0) | View |
| Optic neuritis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Injection site swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Balance disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Carpal tunnel syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Muscle contractions involuntary | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Injection site haematoma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Injection site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Injection site pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |