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 @ 4:53 PM
Ignite Modification Date:
2025-12-25 @ 2:36 PM
NCT ID:
NCT01643850
Description:
None
Frequency Threshold:
0
Time Frame:
Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
Study:
NCT01643850
Study Brief:
MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| MCS110 10 mg/kg (PART A) | Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion | 0 | None | 0 | 5 | 3 | 5 | View |
| Placebo (PART A) | Participants received single dose placebo by i.v. infusion to match MCS110 10 mg/kg | 0 | None | 1 | 2 | 1 | 2 | View |
| MCS110 10mg/kg (PART B) | MCS110 10 mg/kg (i.v. infusion) | 0 | None | 2 | 11 | 11 | 11 | View |
| MCS110 3mg/kg (PART C) | MCS110 3 mg/kg (i.v. infusion) | 0 | None | 3 | 7 | 7 | 7 | View |
| MCS110 5mg/kg (PART C) | MCS110 5 mg/kg (i.v. infusion) | 0 | None | 1 | 7 | 6 | 7 | View |
| MCS110 10mg/kg (PART C) | MCS110 10 mg/kg (i.v. infusion) | 0 | None | 4 | 12 | 11 | 12 | View |
| Placebo/10mg/kg (PART B) | Participants received single dose placebo to match first dose of MCS110 10 mg/kg and then continued with monthly administration of MCS110 10 mg/kg. fter this first single dose of placebo participants switched to monthly administration of MCS110 10 mg/kg and were added to the MCS110 10 mg/kg (PART B) group, which then increased from 8 to 11 participants. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again | 0 | None | 0 | 3 | 3 | 3 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Oesophageal spasm | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (21.1) | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Meningoencephalitis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Streptococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Electrocardiogram ST segment depression | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Facial paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Device dislocation | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (21.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (21.1) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (21.1) | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (21.1) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (21.1) | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (21.1) | View |
| Autoimmune thyroiditis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (21.1) | View |
| Blepharitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (21.1) | View |
| Dark circles under eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (21.1) | View |
| Eye pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (21.1) | View |
| Eye swelling | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (21.1) | View |
| Eyelid oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (21.1) | View |
| Papilloedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (21.1) | View |
| Periorbital oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (21.1) | View |
| Periorbital swelling | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (21.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Haemorrhoidal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Administration site rash | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Face oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Infusion site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Soft tissue inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (21.1) | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (21.1) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Gastroenteritis norovirus | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Peritonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Subcutaneous abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Fibula fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Procedural dizziness | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Amylase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Antinuclear antibody positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Blood cholesterol increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Blood triglycerides increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.1) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.1) | View |
| Fluid retention | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Joint stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Benign joint neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Intracranial pressure increased | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (21.1) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (21.1) | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (21.1) | View |
| Menstrual disorder | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (21.1) | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Dermal cyst | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Dermatitis acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Erythema nodosum | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Pruritus generalised | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Rash generalised | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Skin wrinkling | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Swelling face | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (21.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (21.1) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (21.1) | View |