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 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
NCT ID:
NCT00960804
Description:
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00960804
Study Brief:
Long-Term Study Of The Safety Of Tanezumab In Arthritis Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Tanezumab 5 mg + Standard of Care | Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities. | None | None | 1 | 7 | 6 | 7 | View |
| Tanezumab 10 mg + Standard of Care | Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | None | None | 1 | 4 | 3 | 4 | View |
| Placebo + Standard of Care | Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | None | None | 0 | 10 | 4 | 10 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vitreous floaters | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 14.0 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Seasonal allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 14.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Diverticulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Nerve conduction studies abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Bursitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Lumbar spinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Myositis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Spinal column stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Basal cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Muscle contractions involuntary | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Sciatica | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Ecchymosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Joint swelling | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |