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 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 12:54 AM
NCT ID:
NCT00819234
Description:
None
Frequency Threshold:
5
Time Frame:
52 Weeks, intent to treat population. Enrolled and treated with at least one injection during the extension study DFA102E.
Study:
NCT00819234
Study Brief:
Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin
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 - Stable | Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102. Stable: same treatment regimen in both DFA102 and DFA102E. | None | None | 0 | 31 | 20 | 31 | View |
| 360 mcg Pramlintide + 1.25mg Metreleptin - Stable | Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102. Stable: same treatment regimen in both DFA102 and DFA102E | None | None | 0 | 35 | 25 | 35 | View |
| 360 mcg Pramlintide + 2.5 Metreleptin - Stable | Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102. Stable: same treatment regimen in both DFA102 and DFA102E | None | None | 0 | 36 | 29 | 36 | View |
| 360 mcg Pramlintide + 5.0 Metreleptin - Stable | Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102. Stable: same treatment regimen in both DFA102 and DFA102E | None | None | 0 | 28 | 19 | 28 | View |
| 360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25 | Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. | None | None | 0 | 13 | 10 | 13 | View |
| 360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5 | Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. | None | None | 0 | 14 | 11 | 14 | View |
| 360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0 | Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. | None | None | 0 | 13 | 12 | 13 | View |
| 360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono | Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting. | None | None | 2 | 29 | 26 | 29 | View |
| 360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram | Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting. | None | None | 1 | 37 | 28 | 37 | View |
| 360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram | Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting. | None | None | 1 | 37 | 28 | 37 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Staphylococcal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Muscle strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Papillary thyroid cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | View |
| Cardiac enzymes increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| injection site hemorrhage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| injection site bruising | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| injection site pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| injection site nodule | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| injection site urticaria | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.0) | View |
| gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| muscle strain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| sinus congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| injection site induration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| back injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| injection site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| pharyngolaryngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| bacteriuria | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| hematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.0) | View |
| increased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| injection site irritation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| joint swelling | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| edema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| aphthous stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| enteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| eosinophil count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.0) | View |
| intervertebral disc protusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| nerve compression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| pharyngitis streptococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| sinus headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| thermal burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| tooth abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| urine analysis abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| blood chloride decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| blood sodium increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| conjunctival edema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (11.0) | View |
| dermal cyst | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| electrocardiogram QT prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| eye pruritus | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (11.0) | View |
| hypercalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (11.0) | View |
| hypoesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| malignant melanoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | View |
| nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.0) | View |
| palmar erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| pyuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.0) | View |
| somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |