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 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:54 PM
NCT ID:
NCT00486603
Description:
Adverse events not serious are defined as having Grade 1 and Grade 2 severity
Frequency Threshold:
0
Time Frame:
3 years
Study:
NCT00486603
Study Brief:
Hydroxychloroquine, Radiation, and Temozolomide Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase 1: RT+TMZ+HCQ - 200mg | Daily hydroxychloroquine (HCQ) on 1st day of RT and concomitant temozolomide for 6wks during RT. Dose of HCQ is 200mg. After 6 wks, 4 wkd of HCQ alone daily. this will complete 10 week cycle. -Initiation Phase temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle) pharmacological study: Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4 Radiation: Radiation during the first six weeks of treatment Monday-Friday | 0 | None | 1 | 3 | 3 | 3 | View |
| Phase 1: RT+TMZ+HCQ - 400mg | Daily hydroxychloroquine (HCQ) on 1st day of RT and concomitant temozolomide for 6wks during RT. Dose of HCQ is 400mg. After 6 wks, 4 wkd of HCQ alone daily. this will complete 10 week cycle. -Initiation Phase temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle) pharmacological study: Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4 Radiation: Radiation during the first six weeks of treatment Monday-Friday | 0 | None | 7 | 7 | 7 | 7 | View |
| Phase 1: RT+TMZ+HCQ - 600mg | Daily hydroxychloroquine (HCQ) on 1st day of RT and concomitant temozolomide for 6wks during RT. Dose of HCQ is 600mg. After 6 wks, 4 wkd of HCQ alone daily. this will complete 10 week cycle. -Initiation Phase temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle) pharmacological study: Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4 Radiation: Radiation during the first six weeks of treatment Monday-Friday | 0 | None | 3 | 3 | 3 | 3 | View |
| Phase 1: RT+TMZ+HCQ - 800mg | Daily hydroxychloroquine (HCQ) on 1st day of RT and concomitant temozolomide for 6wks during RT. Dose of HCQ is 800mg. After 6 wks, 4 wkd of HCQ alone daily. this will complete 10 week cycle. -Initiation Phase temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle) pharmacological study: Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4 Radiation: Radiation during the first six weeks of treatment Monday-Friday | 0 | None | 3 | 3 | 3 | 3 | View |
| Phase 2: RT+TMZ+HCQ - MTD 600mg | Daily hydroxychloroquine (HCQ) on 1st day of RT and concomitant temozolomide for 6wks during RT. Dose of HCQ is 600mg MTD. After 6 wks, 4 wkd of HCQ alone daily. this will complete 10 week cycle. -Initiation Phase temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle) pharmacological study: Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4 Radiation: Radiation during the first six weeks of treatment Monday-Friday | 0 | None | 53 | 76 | 76 | 76 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| decreased depth perception | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE 3.0 | View |
| generalized muscle weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | View |
| hyperuricemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| other | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| white blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 3.0 | View |
| anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 3.0 | View |
| hemolysis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 3.0 | View |
| hyperkalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| mood alteration | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 3.0 | View |
| alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 3.0 | View |
| anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 3.0 | View |
| aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| ataxia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| bloating | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| bruising | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE 3.0 | View |
| blurred vision | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE 3.0 | View |
| chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 3.0 | View |
| diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| dysarthria | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| edema limbs | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| erythema multiforme | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| esophageal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| other | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE 3.0 | View |
| fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| feber | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| gastric hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| gastroesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| generalized muscle weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | View |
| headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| hyperkalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| hyperuricemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| hypocalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| hypomagnesemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 3.0 | View |
| other | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| other | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 3.0 | View |
| irritability | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 3.0 | View |
| lipase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| memory impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| mucositis oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| muscle weakness lower limb | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | View |
| nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | View |
| peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| photosensitivity | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| purpura | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| rash acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| serum amylase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| stomach pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| weight loss | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| white blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |