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 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
NCT ID:
NCT02312960
Description:
None
Frequency Threshold:
1
Time Frame:
Up to 7 years
Study:
NCT02312960
Study Brief:
Radium-223 Dichloride Long-term Follow-up Program
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| From Study 15396 Radium-223 Dichloride+Abi/Pred Group | Safety FU from feeder study 15396. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles. | 24 | None | 3 | 39 | 2 | 39 | View |
| From Study 15396 Placebo+Abi/Pred Group | Safety FU from feeder study 15396. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles. | 32 | None | 4 | 49 | 6 | 49 | View |
| From Study 16216 Radium-223 Dichloride Group | Safety FU from feeder study 16216. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles. | 25 | None | 4 | 31 | 0 | 31 | View |
| From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group | Safety FU from feeder study 16298. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with single hormonal agent, for up to 6 cycles. | 11 | None | 1 | 14 | 3 | 14 | View |
| From Study 16298 Placebo + Hormonal Therapy Group | Safety FU from feeder study 16298. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with single hormonal agent for up to 6 cycles. | 5 | None | 1 | 9 | 3 | 9 | View |
| From Study 16506 Radium-223 Dichloride Group | Safety FU from feeder study 16506. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles. | 5 | None | 0 | 5 | 0 | 5 | View |
| From Study 16507 Radium-223 Dichloride Treatment A Group | Safety FU from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 6 cycles. | 8 | None | 2 | 11 | 1 | 11 | View |
| From Study 16507 Radium-223 Dichloride Treatment B Group | Safety FU from feeder study 16507. Participants received radium-223 dichloride 88 kBg/kg at intervals of every 4 weeks for up to 6 cycles. | 5 | None | 3 | 9 | 1 | 9 | View |
| From Study 16507 Radium-223 Dichloride Treatment C Group | Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 12 cycles. | 7 | None | 3 | 11 | 3 | 11 | View |
| From Study 16544 Radium-223 Dichloride+Abi/Pred Group | Safety FU from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with Abi/Pred for up to 6 cycles. | 3 | None | 0 | 9 | 3 | 9 | View |
| From Study 16544 Radium-223 Dichloride+Enzalutamide Group | Safety FU from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with enzalutamide for up to 6 cycles. | 3 | None | 1 | 4 | 1 | 4 | View |
| From Study 16544 Radium-223 Dichloride Group | Safety FU from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks for up to 6 cycles. | 1 | None | 0 | 3 | 1 | 3 | View |
| From Study 17096 Radium-223 Dichloride + EXE/EVE Group | Safety FU from feeder study 17096. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) along with exemestane (EXE) + everolimus (EVE) once daily. | 25 | None | 4 | 33 | 8 | 33 | View |
| From Study 17096 Placebo + EXE/EVEgroup | Safety FU from feeder study 17096. Participants received placebo matched to radium-223 dichloride along with exemestane (EXE) + everolimus (EVE) once daily. | 19 | None | 6 | 28 | 3 | 28 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ankle fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Foot fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Rib fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Lumbar vertebral fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Periprosthetic fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Pathological fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Spondylolisthesis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Acute myeloid leukaemia | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | View |
| Cholangiocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | View |
| Colon cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | View |
| Hepatocellular carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | View |
| Spinal cord compression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Aplastic anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (26.1) | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (26.1) | View |
| Acetabulum fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Osteoporotic fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Osteonecrosis of jaw | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (26.1) | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Haemorrhoidal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Osteomyelitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Ankle fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Foot fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Radius fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Rib fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Spinal compression fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Craniofacial fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.1) | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.1) | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Osteoporosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Osteoporotic fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Pathological fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Osteopenia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Spondylitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Spondylolisthesis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Osteonecrosis of jaw | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Spinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Genital haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (26.1) | View |
| Petechiae | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.1) | View |
| Device failure | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (26.1) | View |