Adverse Events Module

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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 @ 5:45 PM
Ignite Modification Date: 2025-12-25 @ 3:12 PM
NCT ID: NCT02545868
Description: Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
Frequency Threshold: 5
Time Frame: Baseline up 5 years, 10 months, 26 days
Study: NCT02545868
Study Brief: A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of 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
Group A1 Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV boosted with 13-PCV and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24. 0 None 5 33 31 33 View
Group A2 Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24. 0 None 5 35 34 35 View
Group B Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period. No study drug was administered. 0 None 6 34 32 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
VENTRICULAR TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
ANAPHYLACTIC REACTION SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.1 View
APPENDICITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
HERPES ZOSTER DISSEMINATED SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
HEAD INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
OVERDOSE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
SARS-COV-2 TEST POSITIVE SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
LOBULAR BREAST CARCINOMA IN SITU SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
CAROTID ARTERY ANEURYSM SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
CEREBROVASCULAR ACCIDENT SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
ABORTION SPONTANEOUS SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 24.1 View
BIPOLAR DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
CONFUSIONAL STATE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
UTERINE PROLAPSE SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
PALPITATIONS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
VERTIGO SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
OCULAR HYPERAEMIA SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
VISION BLURRED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
ANAL INCONTINENCE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
DYSPHAGIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
CHEST DISCOMFORT SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
CYST SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
GAIT DISTURBANCE SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
INJECTION SITE ERYTHEMA SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
INJECTION SITE PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
INJECTION SITE REACTION SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
INJECTION SITE SWELLING SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
PERIPHERAL SWELLING SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
TEMPERATURE INTOLERANCE SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
SEASONAL ALLERGY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.1 View
EAR INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
FUNGAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
GASTROENTERITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
HERPES ZOSTER SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
LOCALISED INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
LOWER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
ORAL HERPES SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
PHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
PYELONEPHRITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
TOOTH INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
ARTHROPOD BITE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
INFUSION RELATED REACTION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
JOINT INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
LIGAMENT SPRAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
MUSCLE STRAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
PROCEDURAL PAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
SKIN LACERATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
BLOOD CREATINE PHOSPHOKINASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
BLOOD PRESSURE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
VITAMIN D DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
WEIGHT INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
MUSCULAR WEAKNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
NECK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
PAIN IN JAW SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
SYNOVIAL CYST SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
BALANCE DISORDER SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
DYSAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
HYPOAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
LETHARGY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
MIGRAINE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
MULTIPLE SCLEROSIS RELAPSE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
MUSCLE SPASTICITY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
NEURALGIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
PARAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
SCIATICA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
TENSION HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
TREMOR SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
PANIC ATTACK SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
DYSURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
MICTURITION URGENCY SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
NEPHROLITHIASIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
POLLAKIURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
URINARY INCONTINENCE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
URINARY RETENTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
HICCUPS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
PARANASAL SINUS DISCOMFORT SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
SINUS CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
SLEEP APNOEA SYNDROME SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
ACNE SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
ERYTHEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
HAND DERMATITIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
MILIARIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
NIGHT SWEATS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
URTICARIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
HYSTERECTOMY SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.1 View
TOOTH EXTRACTION SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.1 View
HAEMATOMA SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
RAYNAUD'S PHENOMENON SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
VIRAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
VULVOVAGINAL MYCOTIC INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
ANIMAL BITE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
HYPERTONIC BLADDER SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
TOOTHACHE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
CONJUNCTIVITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View