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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT03273712
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
Study:
NCT03273712
Study Brief:
Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 90Y-DOTA-tyr3-Octreotide | Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry. 90Y-DOTA tyr3-Octreotide: 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors. 68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan: 68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors. Amino Acids: This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys. | 5 | None | 14 | 39 | 37 | 39 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Atrioventricular block complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Endocrine disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE v4.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Bronchial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Catheter related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Infections and infestations - Other, specify | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Musculoskeletal and connective tissue disorder - Other, specify | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v4.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Renal and urinary disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Vascular disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Atrioventricular block complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Cardiac disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Ear and labyrinth disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE v4.0 | View |
| Endocrine disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE v4.0 | View |
| Eye disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Gastrointestinal disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Gastroparesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Hemorrhoidal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Oral dysesthesia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Upper gastrointestinal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Edema face | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Flu like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Infusion site extravasation | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Localized edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Hepatobiliary disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE v4.0 | View |
| Bronchial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Catheter related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Infections and infestations - Other, specify | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Investigations - Other, specify | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Musculoskeletal and connective tissue disorder - Other, specify | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v4.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Renal and urinary disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Vascular disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |