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 @ 5:08 PM
Ignite Modification Date:
2025-12-25 @ 2:46 PM
NCT ID:
NCT00934050
Description:
For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Frequency Threshold:
5
Time Frame:
Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up).
Study:
NCT00934050
Study Brief:
ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo/ELND005 2000mg BID | In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks. | None | None | 1 | 12 | 0 | 12 | View |
| 250mg/ELND005 2000mg BID | In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks. | None | None | 1 | 12 | 0 | 12 | View |
| 1000 mg/ELND005 2000 mg BID | In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks. | None | None | 0 | 12 | 0 | 12 | View |
| 2000 mg ELND005/ELND005 2000 mg BID | In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks. | None | None | 2 | 14 | 3 | 14 | View |
| Placebo/ELND005 250 mg BID | In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks. | None | None | 5 | 26 | 11 | 26 | View |
| 250 mg/ELND005 250 mg BID | In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks. | None | None | 6 | 27 | 15 | 27 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cardiac Failure Congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Klebsiella Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Femoral Neck Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Lumbar Vertebral Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Rib Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Musculoskeletal Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Basal Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Bladder transitional Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Colon Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Transient Ischaemic Attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Confusional State | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Acute Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pneumonia Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain In Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |