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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
NCT ID:
NCT02841267
Description:
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
Frequency Threshold:
0
Time Frame:
Baseline through 124 weeks
Study:
NCT02841267
Study Brief:
A Trial of PF-06252616 in Ambulatory Participants With LGMD2I
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort 1 - Low Dose | Subjects received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks for 32 weeks. | 0 | None | 0 | 4 | 4 | 4 | View |
| Cohort 1 Extension | Subjects enrolled in Cohort 1 were given the option to receive PF 06252616 at 40 mg/kg every 4 weeks for an additional 28 weeks. | 0 | None | 0 | 4 | 4 | 4 | View |
| Cohort 2 | Subjects received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks. | 0 | None | 0 | 7 | 6 | 7 | View |
| Cohort 2 Extension | Subjects enrolled in Cohort 2 were given the option to receive PF 06252616 at 40 mg/kg every 4 weeks for an additional 40 weeks. | 0 | None | 1 | 6 | 4 | 6 | View |
| Cohort 3 | Subjects received 40 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks. | 0 | None | 0 | 8 | 7 | 8 | View |
| Cohort 3 Extension | Subjects enrolled in Cohort 3 were given the option to receive PF 06252616 at 40 mg/kg every 4 weeks for an additional 24 weeks. | 0 | None | 0 | 6 | 6 | 6 | View |
| Lead-in | All subjects were observed in a 16-week untreated lead-in-phase prior to allocation to dosing cohorts. | 0 | None | 1 | 19 | 9 | 19 | View |
| Cohort 1 - High Dose | Following the Low Dose period, subjects in Cohort 1 received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks. | 0 | None | 0 | 4 | 4 | 4 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infectious illness - not otherwise specified | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Gastroesophageal reflux | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Low serum ferritin | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Hemoccult positive | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| New diagnosis - carpal tunnel syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| New diagnosis - hepatic steatosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 20.1 | View |
| New diagnosis - umbilical hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| New diagnosis - bipolar disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| New diagnosis - personality disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Pain associated with muscle biopsy | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Numbness following biopsy | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Lower extremity edema following biopsy | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Skin avulsion following biopsy | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Intravenous catheter infiltration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Ecchymosis at IV site | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Fall - not otherwise specified | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Musculoskeletal pain post fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Fracture - pelvic | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Knee injury post fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Shoulder injury post fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Facial injury post fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Ankle injury post fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Shoulder pain - not otherwise specified | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Knee pain - not otherwise specified | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Neck pain - not otherwise specified | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Hip pain - not otherwise specified | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Worsening cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.1 | View |
| Upper respiratory symptoms | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Flu-like illness | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Environmental allergies | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 20.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Urinary tract pain | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Prostatic hypertrophy | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Hematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Vaginal yeast infection | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.1 | View |
| Blepharitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Vision abnormality - not otherwise specified | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Eye twitching | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.1 | View |
| Ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.1 | View |
| Hearing loss | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.1 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Rash - not otherwise specified | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Cold sore | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Cyst - not otherwise specified | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Pruritis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Dental injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Dental infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Weight gain | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Weight loss | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Hypoglycemia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Ketones detected in urine | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Red blood cells in urine | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Elevated serum iron levels | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Low serum iron levels | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Elevated amylase | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Elevated serum ferritin | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |