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 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
NCT ID:
NCT00999518
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. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
Frequency Threshold:
4
Time Frame:
None
Study:
NCT00999518
Study Brief:
A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome
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 | Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24. | None | None | 0 | 42 | 21 | 42 | View |
| Tanezumab 1 mg | Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24. | None | None | 4 | 41 | 25 | 41 | View |
| Tanezumab 2.5 mg | Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24. | None | None | 6 | 37 | 15 | 37 | View |
| Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24. | None | None | 1 | 40 | 27 | 40 | View |
| Tanezumab 20 mg | Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24. | None | None | 1 | 40 | 22 | 40 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute coronary syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.0 | View |
| Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.0 | View |
| Bone 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 |
| Rotator cuff syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Unintended pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | View |
| Suicide attempt | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.0 | View |
| Bladder pain | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.0 | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.0 | View |
| Menorrhagia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 14.0 | View |
| Breast cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Eye swelling | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 14.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Muscle twitching | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Myalgia | 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 |
| Tendonitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Allodynia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Carpal tunnel syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Decreased vibratory sense | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Hyperaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.0 | View |
| Bladder pain | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.0 | View |
| Cystitis interstitial | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.0 | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.0 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.0 | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |