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:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
NCT ID:
NCT00870818
Description:
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
Frequency Threshold:
2
Time Frame:
Throughout the study, up to 15 months
Study:
NCT00870818
Study Brief:
Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Open-label Herold Regimen | Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets | 0 | None | 1 | 32 | 8 | 32 | View |
| Double-blind Herold Regimen | Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets | 1 | None | 5 | 73 | 2 | 73 | View |
| Double-blind 33.3% Herold Regimen | Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets | 0 | None | 3 | 38 | 1 | 38 | View |
| Double-blind Curtailed Herold Regimen | Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets | 0 | None | 4 | 38 | 10 | 38 | View |
| Double-blind Placebo | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets | 0 | None | 0 | 38 | 4 | 38 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypoglycaemic seizure | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Appendicitis perforated | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Varicella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Caustic injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Iritis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Abortion spontaneous | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA | View |
| Diabetes mellitus inadequate control | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEddra | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fungal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Gastrointestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pharyngitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Tinea infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Diabetic neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Diabetic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Liver disorder | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA | View |
| Diabetic nephropathy | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Epstein-Barr virus antibody positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |