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 @ 2:35 PM
Ignite Modification Date:
2025-12-25 @ 1:07 PM
NCT ID:
NCT02348359
Description:
None
Frequency Threshold:
5
Time Frame:
All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Study:
NCT02348359
Study Brief:
X-82 to Treat Age-related Macular Degeneration
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 50 mg of X-82 Plus Ivt Anti-VEGF Prn | Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. X-82 Anti-VEGF | 0 | None | 6 | 40 | 39 | 40 | View |
| 100 mg of X-82 Plus Ivt Anti-VEGF Prn | Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. X-82 Anti-VEGF | 1 | None | 7 | 39 | 38 | 39 | View |
| 200 mg of X-82 Plus Ivt Anti-VEGF Prn | Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. X-82 Anti-VEGF | 0 | None | 3 | 39 | 37 | 39 | View |
| Placebo Plus Ivt Anti-VEGF Prn | Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. Anti-VEGF Placebo | 0 | None | 2 | 39 | 34 | 39 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA 17.1 | View |
| lower gastrointestinal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 17.1 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedRA 17.1 | View |
| sudden cardiac death | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA 17.1 | View |
| Endopthalmitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 17.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 17.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 17.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 17.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 17.1 | View |
| Hip fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedRA 17.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedRA 17.1 | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedRA 17.1 | View |
| Bladder cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 17.1 | View |
| Basal cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 17.1 | View |
| Endometrial cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 17.1 | View |
| B cell lymphoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 17.1 | View |
| Oesophageal carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 17.1 | View |
| Squamous cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 17.1 | View |
| Cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA 17.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA 17.1 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedRA 17.1 | View |
| Hypertensive crisis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedRA 17.1 | View |
| Angioedema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedRA 17.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrioventricular block | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA 17.1 | View |
| Supraventricular systole | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA 17.1 | View |
| Conjunctival hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedRA 17.1 | View |
| Vitreous detachment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedRA 17.1 | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedRA 17.1 | View |
| Retinal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedRA 17.1 | View |
| Dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedRA 17.1 | View |
| Visual acuity reduced | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedRA 17.1 | View |
| Neovascular age related macular degeneration | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedRA 17.1 | View |
| Vitreous floaters | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedRA 17.1 | View |
| Diplopia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedRA 17.1 | View |
| Eye irritation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedRA 17.1 | View |
| Photopsia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedRA 17.1 | View |
| Vision blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedRA 17.1 | View |
| Eye pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedRA 17.1 | View |
| Eyelash discoloration | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedRA 17.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 17.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 17.1 | View |
| Urine protein/creatinine ratio increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedRA 17.1 | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedRA 17.1 | View |
| Ageusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA 17.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA 17.1 | View |
| Metamorphopsia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedRA 17.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 17.1 | View |
| nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 17.1 | View |
| vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 17.1 | View |
| dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 17.1 | View |
| abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 17.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 17.1 | View |
| Eructation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 17.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedRA 17.1 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedRA 17.1 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedRA 17.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 17.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 17.1 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 17.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 17.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 17.1 | View |
| Diverticulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 17.1 | View |
| Tinea cruris | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 17.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedRA 17.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedRA 17.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedRA 17.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedRA 17.1 | View |
| Blood pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedRA 17.1 | View |
| Bllod creatinine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedRA 17.1 | View |
| Blood glucose increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedRA 17.1 | View |
| Hepatic enzyme increase | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedRA 17.1 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedRA 17.1 | View |
| Urine analysis abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedRA 17.1 | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedRA 17.1 | View |
| White blood cells urine positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedRA 17.1 | View |
| Prostate specific antigen increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedRA 17.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedRA 17.1 | View |
| Vitamin D deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedRA 17.1 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedRA 17.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedRA 17.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedRA 17.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedRA 17.1 | View |
| Squamous cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 17.1 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA 17.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA 17.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA 17.1 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedRA 17.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedRA 17.1 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedRA 17.1 | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedRA 17.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedRA 17.1 | View |
| Sinus congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedRA 17.1 | View |
| Hair color change | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedRA 17.1 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedRA 17.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedRA 17.1 | View |