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 @ 4:19 PM
Ignite Modification Date:
2025-12-25 @ 2:16 PM
NCT ID:
NCT04075266
Description:
Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.
Frequency Threshold:
5
Time Frame:
Up to 3.7 years
Study:
NCT04075266
Study Brief:
A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Ocrelizumab 300 mg | Participants who weighed between 25 kg to 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 300 mg was administered as a single IV infusion given 24 weeks apart. | 0 | None | 1 | 6 | 5 | 6 | View |
| Ocrelizumab 600 mg | Participants who weighed 40 kg or more were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 600 mg was administered as a single IV infusion given 24 weeks apart. | 0 | None | 4 | 17 | 17 | 17 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Candida infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Gonococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Abscess limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Conversion disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 26.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 26.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 26.1 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 26.1 | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | 26.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Defaecation urgency | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Irritable bowel syndrome | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Temperature intolerance | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | 26.1 | View |
| Adenovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Anal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Bacterial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Bacterial vaginosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Nasal herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Arthropod sting | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Product preparation error | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Torus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Blood immunoglobulin G decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Blood immunoglobulin M decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Blood triglycerides increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| CD4 lymphocytes decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| International normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Monocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Protein urine present | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Urine output decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Vitamin D decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Hypertriglyceridaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Benign neoplasm of thyroid gland | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.1 | View |
| Skin papilloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.1 | View |
| Brain fog | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Cognitive disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Decreased vibratory sense | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Dizziness postural | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Facial paresis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Nervous system disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Conversion disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 26.1 | View |
| Initial insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 26.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 26.1 | View |
| Mood altered | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 26.1 | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 26.1 | View |
| Micturition urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 26.1 | View |
| Amenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 26.1 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 26.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Throat irritation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Upper respiratory tract congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Skin disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Wisdom teeth removal | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | 26.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 26.1 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Ligament rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| CD8 lymphocytes decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Electrocardiogram QT prolonged | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Fungal test positive | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Pain in jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Sensory loss | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 26.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Monocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 26.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 26.1 | View |
| Bundle branch block left | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 26.1 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 26.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 26.1 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 26.1 | View |
| Hyperprolactinaemia | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 26.1 | View |
| Chalazion | SYSTEMATIC_ASSESSMENT | Eye disorders | 26.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Gastrointestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Herpes virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Immunisation reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |