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 @ 11:51 AM
Ignite Modification Date: 2025-12-24 @ 11:51 AM
NCT ID: NCT00773461
Description: There are 70 participants randomized in Placebo+DMARDs group. Of these, 2 participants were excluded from safety population because one didn't receive any treatment while another received treatment but had no post-baseline safety assessment. Thus, a total of 68 participants were included in safety Population.
Frequency Threshold: 0
Time Frame: Adverse events were monitored and recorded throughout the study.
Study: NCT00773461
Study Brief: A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo + DMARDs Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy None None 4 68 19 68 View
Tocilizumab + DMARDs Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy None None 1 139 59 139 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abscess Limb NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Herpes Zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Uterine Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Neutrophil Count Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Abscess limb NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Helicobacter infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Uterine infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Transaminases increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Blood bilirubin unconjugated increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Hepatic enzyme increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Aphthous stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Cheilitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Gingival ulceration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Mouth ulceration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Skin disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Neuropathy peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Dysfunctional uterine bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Dysmenorrhoea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Menstruation irregular NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Uterine cervical erosion NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.1 View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.1 View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Hyperlipidaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View