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 @ 9:22 PM
Ignite Modification Date: 2025-12-25 @ 7:08 PM
NCT ID: NCT02047604
Description: None
Frequency Threshold: 5
Time Frame: Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
Study: NCT02047604
Study Brief: (C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With 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
Cohort A - SAN-300 0.5 mg/kg QW SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks 0 None 0 6 1 6 View
Cohort B - SAN-300 1.0 mg/kg QW SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks 0 None 0 7 1 7 View
Cohort C - SAN-300 2.0 mg/kg QOW SAN-300 2.0 mg/kg subcutaneous every other week for six weeks 0 None 0 6 1 6 View
Cohort D - SAN-300 4.0 mg/kg QOW SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks 0 None 2 6 6 6 View
Cohort E - SAN-300 4.0 mg/kg QW SAN-300 4.0 mg/kg subcutaneous every week for six weeks 0 None 0 6 2 6 View
Placebo Placebo dosing 0 None 0 10 3 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Flank Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
diarrheoa SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Mouth Ulcerations SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection Site Rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection Site Reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Blood Pressure Increase SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Electrocardiogram Abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Headaches SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View