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 @ 2:12 AM
Ignite Modification Date:
2025-12-26 @ 12:40 AM
NCT ID:
NCT03287960
Description:
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
Frequency Threshold:
5
Time Frame:
From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
Study:
NCT03287960
Study Brief:
Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Setmelanotide | Participants received titrated doses of setmelanotide once daily, by SC injection during titration period for 2 - 12 weeks. Thereafter, participants continued setmelanotide at their specific therapeutic dose for an additional 10 weeks during the open label treatment period. Participants who achieved at least a 5 kg weight loss (or at least 5% weight loss if baseline body weight was \<100 kg) at the end of the open label treatment period, continued into the 8-week double-blind withdrawal period and received 4 weeks setmelanotide and 4 weeks placebo. Following the withdrawal period, participants entered open label treatment period and received setmelanotide to complete approximately 52 weeks (\~1 year) of treatment at a therapeutic dose. | 1 | None | 3 | 15 | 15 | 15 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA | View |
| Road Traffic Accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Suicidal Ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.0 | View |
| Gastric Banding Reversal | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 22.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Xerosis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 22.0 | View |
| Spontaneous penile erection | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 22.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| Arthritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.0 | View |
| Melanocytic naevus | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| Eye naevus | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Injection site oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Injection site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Injection site haematoma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Injection site hypersensitivity | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Injection site atrophy | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Injection site urticaria | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Medical device pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Medical device site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.0 | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Affect lability | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Drug abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.0 | View |
| Fear of injection | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.0 | View |
| Illusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.0 | View |
| Ejaculation disorder | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 22.0 | View |
| Metrorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 22.0 | View |
| Amenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 22.0 | View |
| Ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 22.0 | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| Joint Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| Blood creatine phosphokinase abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| Blood follicle stimulating hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| Blood luteinising hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| Blood urea decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| Blood uric acid increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| Heart rate increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| Insulin tolerance test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| Neutrophil count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| Cardiac flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.0 | View |
| Eosinophilia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.0 | View |
| Iron deficiency anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Sleep paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Tic | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 22.0 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 22.0 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 22.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Gingival discolouration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Cholestasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 22.0 | View |
| Hepatocellular injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 22.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.0 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.0 | View |
| Renal colic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.0 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.0 | View |
| Skin hyperpigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Skin striae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Hair growth rate abnormal | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Hyperkeratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Lentigo | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Lipodystrophy acquired | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Melanocytic naevus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Pain of skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Pigmentation disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| Torticollis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 22.0 | View |
| Hypogonadism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 22.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.0 | View |
| Dyslipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.0 | View |
| Folate deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.0 | View |
| Glucose tolerance impaired | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.0 | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.0 | View |
| Vitamin A deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.0 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Gastrointestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Injection site abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Otitis externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |