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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 11:44 PM
NCT ID:
NCT03805594
Description:
None
Frequency Threshold:
5
Time Frame:
Up to 3 years
Study:
NCT03805594
Study Brief:
177Lu-PSMA-617 and Pembrolizumab in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part A: Dosing Schedule 1 (Lutetium Lu 177-PSMA-617, Pembrolizumab) | Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Beginning in cycle 2, participants receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve stable disease (SD) or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab. | 4 | None | 0 | 6 | 6 | 6 | View |
| Part A: Dosing Schedule 2 (Lutetium Lu 177-PSMA-617, Pembrolizumab) | Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab. | 3 | None | 2 | 6 | 6 | 6 | View |
| Part A: Dosing Schedule 3 (Lutetium Lu 177-PSMA-617, Pembrolizumab) | Starting day -21, participants receive pembrolizumab IV over 30 minutes. Participants also receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab. | 4 | None | 1 | 6 | 6 | 6 | View |
| Part B: Recommended Phase 2 Dosing Schedule (RP2DS) (Lutetium Lu 177-PSMA-617, Pembrolizumab) | Participants will receive the RP2DS determined in Part A. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab. | 5 | None | 5 | 25 | 24 | 25 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infections and infestations - Other | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Renal and urinary disorders - Other | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Tumor pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Renal and urinary disorders - Other | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Pelvic pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (5.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Localized edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Facial pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Flu like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Gastrointestinal disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Chest wall pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Muscle cramp | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Metabolism and nutrition disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Cognitive disturbance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (5.0) | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Erythema multiforme | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Breast pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (5.0) | View |
| Hot flashes | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Ear and labyrinth disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (5.0) | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | View |
| Psychiatric disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (5.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |